TLJ Daily E-Mail Alert No. 1,261, November 29, 2005.
November 29, 2005, 8:00 AM ET, Alert No. 1,261.
11/28. The Supreme Court granted certiorari in eBay v. Mercexchange, a patent infringement case against eBay involving the fixed-price purchasing feature of eBay's website. The main issue is the standard to be followed by courts in granting injunctions against infringement.
The relevant statute, which is codified at 35 U.S.C. § 283, provides that "The several courts having jurisdiction of cases under this title may grant injunctions in accordance with the principles of equity to prevent the violation of any right secured by patent, on such terms as the court deems reasonable."
eBay and its amicus curiae supporters argue that Federal Circuit opinions do not follow Section 283. Rather, they all but ignore the "principles of equity" language, and require District Courts to accord patent holders an irrebuttable presumption of entitlement to injunctive relief. Moreover, they argue that these automatic injunctions have dire consequences for the information technology sector.
Proponents of injunctive relief argue that patents are a form of property, and that the essential attributes of property are the owner's right to use the property, and the owner's right to exclude others from using the property. However, patent law confers no right to use upon the owner -- only a right to exclude. Moreover, since patents by nature are conceptual, and publicly disclosed, the owner has no means of excluding, other than by judicial injunction. If deprived of injunctive relief, the character of the right is substantially degraded, and the patent is of much less value. And hence, the incentive to invest, research, develop, and disclose is substantially lessened.
This is also one of the main issues involved in current debates in the Congress regarding patent law reform. While some internet based companies, such as eBay, support legislation that would raise the standard for issuance injunctions, many patent holders oppose such efforts. There have been numerous House and Senate hearings in 2005, and considerable lobbying and negotiations; however, no consensus has been obtained, and no bill has yet been reported by either the House Judiciary Committee or Senate Judiciary Committee.
The Supreme Court may provide eBay some of the relief that it has been unable to obtain from the Congress.
The Supreme Court wrote in its November 28 Order List [20 pages in PDF] that "The petition for a writ of certiorari is granted. In addition to the Question presented by the petition, the parties are directed to brief and argue the following Question: "Whether this Court should reconsider its precedents, including Continental Paper Bag Co. v. Eastern Paper Bag Co., 210 U.S. 405 (1908), on when it is appropriate to grant an injunction against a patent infringer."
While the Supreme Court's order references its 1908 opinion in Continental Paper Bag, it is a series of recent opinions issued by the U.S. Court of Appeals (FedCir) that is guiding District Court Judges' decisions regarding the issuance of injunctions.
Continental Paper Bag? Continental Paper Bag has not heretofore been at the center of debates regarding the issuance of injunctions in patent cases. It is a nearly 100 year old case involving paper bags, not information technology. The parties and amici all but ignored Continental Paper Bag in their pleadings. eBay cites it only once, late in its brief. The Court of Appeals did not cite it.
The Supreme Court's opinion in Continental Paper Bag acknowledges both the importance of granting injunctive relief to patent holders to maintain exclusivity, and of applying principles of equity. But, it does not provide lower courts clear guidance on standards for issuing injunctive relief.
The Court wrote that "The right which a patentee receives does not need much further explanation. We have seen that it has been the judgment of Congress from the beginning that the sciences and the useful arts could be best advanced by giving an exclusive right to an inventor."
It continued that "From the character of the right of the patentee we may judge of his remedies. It hardly needs to be pointed out that the right can only retain its attribute of exclusiveness by a prevention of its violation. Anything but prevention takes away the privilege which the law confers upon the patentee."
However, the Court added the following language, which eBay cites in its petition: "If the conception of the law that a judgment in an action at law is reparation for the trespass, it is only for the particular trespass that is the ground of the action. There may be other trespasses and continuing wrongs and the vexation of many actions. These are well-recognized grounds of equity jurisdiction, especially in patent cases, and a citation of cases is unnecessary. Whether, however, as case cannot arise where, regarding the situation of the parties in view of the public interest, a court of equity might be justified in withholding relief by injunction, we do not decide."
Proceedings Below. Mercexchange is the holder of U.S. Patent No. 5,845,265, tilted "Consignment Nodes", U.S. Patent No. 6,085,176, titled "Method and apparatus for using search agents to search plurality of markets for items", and U.S. Patent No. 6,202,051, titled "Facilitating internet commerce through internetworked auctions".
Mercexchange filed a complaint in U.S. District Court (EDVa) against eBay and two other companies alleging infringement of three patents.
To greatly oversimplify this proceeding, the District Court found willful infringement of some claims, and awarded damages, but not injunctive relief. District Court's opinion is reported at 275 F.Supp. 2d 695. Both eBay and Mercexchange appealed on various issues.
The Court of Appeals issued its opinion [31 pages in PDF] on March 16, 2005, and an errata [1 page in PDF] on March 22, 2005. This opinion is also reported at 401 F.3d 1323.
Again, to greatly oversimplify this proceeding, the Court of Appeals reversed the denial of injunctive relief. It wrote that there is "no reason to depart from the general rule that courts will issue permanent injunctions against patent infringement absent exceptional circumstances."
The Court, quoting from its 1989 opinion in Richardson v. Suzuki Motor Co., 868 F.2d 1226, wrote that "Because the ``right to exclude recognized in a patent is but the essence of the concept of property,´´ the general rule is that a permanent injunction will issue once infringement and validity have been adjudged."
eBay petitioned the Supreme Court for writ of certiorari.
eBay's Petition. eBay argued in its petition for writ of certiorari [PDF, long download] that "This case presents an important question of federal patent law with significant implications for the Nation's economy. A permanent injunction in the context of patent law is a potent remedy. The enjoined defendant is faced with tough choices: redesign its product or the product's functionality to eliminate reliance on the patent, negotiate a license on possibly onerous terms, or cease production or use altogether. Recognizing that this powerful and coercive remedy is not always appropriate, Congress has expressly authorized district courts to use the equitable discretion in granting injunction in patent cases. In particular, § 283 of the Patent Act provides that an injunction may issue to prevent future violations only when the relief comports with the principles of equity. ..."
eBay argued that "The Federal Circuit has decided to ignore this rule. And in its place, the court of appeals has authored its own variant of § 283, replacing equitable discretion with a virtually irrebuttable presumption that permanent injunctions will issue absent the exceptional circumstance where injunctive relief would pose a harm to the public interest by endangering the public health."
"The consequences of this rule are clear. Injunctions will issue even when, as in this case, the district court has decided that the balance of the equities requires otherwise. Plaintiffs who will suffer no irreparable injury, because their future losses are fully compensable by ordinary money damages, nevertheless would receive a patent injunction", wrote eBay.
Amicus Curiae Support for eBay. This case has attracted some amicus curiae briefs.
The Computer and Communications Industry Association (CCIA), a Washington DC based interest group that represents some information technology companies, submitted a brief [PDF] in which it urged the Supreme Court to grant certiorari.
It wrote that "The Federal Circuit’s standard of automatic injunctive relief is fundamentally hostile towards complex products, especially today’s extremely complex, systems-based digital information technology. The value of a deeply embedded patented function or component may be miniscule in relation to the value of the finished product and the costs of bringing it to market. Under such conditions, the extraordinary leverage accorded by automatic injunctive relief enables the patentee to extract settlements that approach the costs of shutting down an entire product line, far in excess of what a reasonable royalty is likely to be."
They wrote that the Federal Circuit "has effectively read the terms ``may´´ and ``in accordance with principles of equity´´ out of the statute. In no case in the last twenty years has the Federal Circuit permitted a district court to apply its equitable powers to refuse a permanent injunction after a finding of infringement. Indeed, the court’s grant of permanent injunctive relief is so automatic that it rarely even recites the equitable factors any longer, relying instead on an all-but-conclusive presumption that injunctive relief is appropriate."
They want the Supreme Court "to confirm the applicability of traditional principles of equity to patent law."
The Electronic Frontier Foundation (EFF), a California based interest group that advocates the weakening of all forms of intellectual property rights, submitted a brief [23 pages in PDF] in which it urged the Supreme Court to grant certiorari.
It wrote that "The Federal Circuit Court of Appeals has overstepped its bounds and, in the process, tied the hands of federal judges around the nation. Flagrantly rejecting the plain language of the United States Patent Code and the clear discretionary powers it grants, not to mention longstanding common-law remedies doctrines, the Federal Circuit has imposed an ``automatic injunction´´ rule in patent cases that ignores important equitable considerations -- including those affecting free speech and other activities protected by the First Amendment."
The EFF elaborated on its First Amendment concerns. It argued that the courts, in determining whether to grant an injunction, must balance the interests of the patent holder with the public's interest in free expression. "Such balance is particularly necessary in Internet-related patent actions. Tools such as websites and ``blogging´´ have become increasingly popular means of expression. Video and audio streaming technology is ubiquitous. Email and Instant Messaging are essential communications media. As more and more people use software and Internet technology to express themselves online, more and more speech is potentially subject to regulation by intellectual property laws that govern the use of these technologies."
"Patent owners who claim control over Internet publishing mechanisms are in a position to threaten anyone who uses them, even for personal noncommercial purposes. Thus, forcing courts to grant mandatory injunctive relief to patent owners gives those owners the right to control who can speak on the Internet. The Federal Circuit’s rule denies judges the discretion they will need to address this problem."
The EFF brief lists some patents on internet technologies. However, it does not identify any instances in which a patent holder has engaged in a content based assertion of patent rights. That is, it has not cited any example in which a patent holder has sought or obtained an injunction for the purpose of suppressing any particular speaker with whom the patent holder disagrees.
More Information. eBay is represented by Carter Philips of the Washington DC office of the law firm of Sidley Austin. Mercexchange is represented by Scott Robertson of the Washington DC office of the law firm of Hunton & Williams.
The Business Software Alliance (BSA), America Online (AOL), and Qualcomm also submitted amicus briefs.
11/28. Federal Communications Commission (FCC) Chairman Kevin Martin named Nancy Victory (at right) Chair of the FCC’s Independent Panel Reviewing the Impact of Hurricane Katrina on Communications Networks. She is a partner in the law firm of Wiley Rein & Fielding (WRF). Martin previously worked at WRF. She is also a former head of the National Telecommunications and Information Administration (NTIA). She is also Chair of the FCC's Advisory Committee for the 2007 World Radiocommunication Conference (WRC-07). See, story titled "Powell Appoints Nancy Victory to WRC-07 Post" in TLJ Daily E-Mail Alert No. 761, October 20, 2003. She is also a member of the Progress & Freedom Foundation's (PFF) Digital Age Communications Act Project's (DACA) Advisory Committee. See, FCC release [PDF].
11/28. Kevin Washington was named Director of the Federal Communications Commission's (FCC) Office of Legislative Affairs. He was previously Deputy Director of the Department of Education's No Child Left Behind Office of Communications and Outreach. See, FCC release [PDF].
The House will next meet on Tuesday, December 6, 2005.
The Senate will next meet on Monday, December 12, 2005.
10:00 AM. The Supreme Court will hear oral argument in Illinois Tool Works v. Independent Ink, No. 04-1329, a patent tying antitrust case. See, story titled "Supreme Court Grants Certiorari in Patent Tying Antitrust Case" in TLJ Daily E-Mail Alert No. 1,158, June 21, 2005.
12:00 NOON - 1:30 PM. The Federal Communications Bar Association (FCBA) will host an event titled "The On-Going Debate Over the Sunshine Act". Location: 6th floor, Sidley Austin, 1501 K Street, NW.
9:30 AM - 5:00 PM. The Senate Commerce Committee (SCC) will host an event titled "Open Forum on Decency". Press contact: Melanie Alvord (Stevens) at 202 224-8456 or Melanie_Alvord at commerce dot senate dot gov, or Aaron Saunders (Stevens) at 202 224-3991 or Aaron_Saunders at commerce dot senate dot gov. Location: Room 50, Dirksen Building.
9:00 AM - 4:00 PM. The National Archives and Records Administration's (NARA) Advisory Committee on the Electronic Records Archives (ACERA) will hold a meeting. The NARA asserts that registration is required for attendance. See, notice in the Federal Register, November 15, 2005, Vol. 70, No. 219, at Pages 69360. Location: 700 Pennsylvania Ave., NW.
9:30 AM. The Federal Communications Commission's (FCC) North American Numbering Council (NANC) will meet. See, notice in the Federal Register, November 9, 2005, Vol. 70, No. 216, at Pages 68045 - 68046. Location: FCC, Commission Meeting Room (Room TW-C305), 445 12th Street, SW.
10:30 AM. The U.S. District Court (DC) will hold a supplemental status conference in U.S. v. Microsoft, D.C. Nos. 98-1232 and 98-1233. Judge Colleen Kotelly will preside. Location: Courtroom 11, Prettyman Courthouse, 333 Constitution Ave., NW.
11:45 AM - 1:00 PM. BellSouth's CTO Bill Smith will hold a news conference on network neutrality. Lunch will be served. BellSouth's notice states "Working Press Only Please". RSVP to Bill McCloskey at 202 463-4129. Location: BellSouth, 1133 21st St., NW, Suite 900.
TIME? The Federal Communications Bar Association's (FCBA) will host a luncheon on the future of regulation of communications. The panelists will be Ray Gifford (Progress and Freedom Foundation), Andy Schwartzman (Media Access Project), Jeannine Kenney (Consumers Union), and Jerry Ellig (Mercatus Center at George Mason University). The moderators will be FCBA President Michele Farquhar and Bryan Tramont. Location: Hogan & Hartson, 13th floor, 555 13th Street, NW.
2:00 - 3:00 PM. The Department of State's (DOS) International Telecommunication Advisory Committee (ITAC) will meet to prepare for meetings of the Organization for Economic Cooperation and Development/Committee for Information, Computer and Communications Policy (OECD/ICCP) Working Parties ITU-D Telecommunication Development Advisory Group (TDAG). See, notice in the Federal Register, October 26, 2005, Vol. 70, No. 206, at Page 61876. Location: DOS, Harry Truman Building, Room 2533A.
10:00 AM. The Antitrust Modernization Commission (AMC) will meet. There will be a panel from 10:00 AM to 12:00 NOON titled "Government Civil Remedies". There will be three panels from 1:15 - 4:30 PM titled "Statutory Immunities and Exemptions". See, notice in the Federal Register, November 16, 2005, Vol. 70, No. 220, at Page 69511. Location: Federal Trade Commission, Conference Center, 601 New Jersey Ave., NW.
12:00 NOON - 2:00 PM. The Forum on Technology will host an event titled "The Future of Broadband". See, notice. Location: Room G50, Dirksen Building, Capitol Hill.
12:00 NOON. The Heritage Foundation will host a lecture by Tom Bethell, author of the book titled The Politically Incorrect Guide to Science [Amazon]. See, notice. Location: Heritage, 214 Massachusetts Ave., NE.
12:30 - 2:00 PM. The Federal Communications Bar Association's (FCBA) International Telecommunications Practice Committee will host a brown bag lunch. David Gross (U.S. Coordinator for Communications and Information Policy at the State Department) will discuss the November meeting of the World Summit on Information Society (WSIS) in Tunis, Tunisia. Location: Hogan & Hartson, 555 13th St., NW, Concourse Level.
10:00 AM - 4:30 PM. The Antitrust Modernization Commission (AMC) will meet. The topic will be "Statutory Immunities and Exemptions". See, prepared testimony [PDF] of John Sullivan, prepared testimony [PDF] of James Miller, prepared testimony [27 pages in PDF] of Peter Carstenen (University of Wisconsin law school), and prepared testimony [44 pages in PDF] of Darren Bush, Gregory Leonard (NERA Economic Consulting), and Stephen Ross (University of Illinois law school). See, AMC notice and notice in the Federal Register, Vol. 70, No. 220, November 16, 2005, at Page 69511. Location: FTC, Conference Center, 601 New Jersey Ave., NW.
CANCELLED. 6:00 - 8:15 PM. The Federal Communications Bar Association (FCBA) will host a continuing legal education (CLE) seminar titled "Regulation in the Post-Katrina Environment".
Deadline to submit initial comments to the Copyright Office in response to its notice of inquiry (NOI) regarding exempting certain classes of works from the prohibition against circumvention of technological measures that control access to copyrighted works. See, 17 U.S.C. § 1201(a), and notice in the Federal Register, October 3, 2005, Vol. 70, No. 190, at Pages 57526 - 57531.
Deadline for the National Cable & Telecommunications Association's (NCTA) and Consumer Electronics Association (CEA) to file their second round of status reports with the Federal Communications Commission (FCC) regarding progress in talks regarding the feasibility of a downloadable security solution for integrating navigation and security functionalities in cable set top boxes. See, FCC's Second Report and Order [37 pages in PDF] adopted and released on March 18, 2005. This order is FCC 05-76 in CS Docket No. 97-80. See also, FCC release [PDF] summarizing this order, and story titled "FCC Again Delays Deadline for Integrating Navigation and Security Functionalities in Cable Set Top Boxes" in TLJ Daily E-Mail Alert No. 1,099, March 21, 2005. See also, notice of extensions (DA 05-1930) [2 pages in PDF].
8:30 AM - 3:00 PM. The National Institute of Standards and Technology's (NIST) Malcolm Baldrige National Quality Award Board of Overseers will meet. See, notice in the Federal Register, November 18, 2005, Vol. 70, No. 222, at Page 69954. Location: NIST, Administration Building, Room A1038, Gaithersburg, MD.
12:00 NOON - 1:45 PM. The American Enterprise Institute (AEI) will host a luncheon titled "The State of Trade: The Doha WTO Round, APEC, and the FTAA". The speakers will be Claude Barfield (AEI), James Glassman (AEI), and Arvind Panagariya (Columbia University). See, notice. Location: Twelfth floor, 1150 17th St., NW.
Deadline to submit comments to the Office of the U.S. Trade Representative (USTR) regarding its out of cycle reviews (OCRs) of Russia, Canada, Indonesia and the Philippines. These OCRs pertain to the identification of countries that deny adequate and effective protection of intellectual property rights or deny fair and equitable market access to U.S. persons who rely on intellectual property protection. See, notice in the Federal Register: September 29, 2005, Vol. 70, No. 188, at Pages 56963 - 56964.
1:00 - 5:00 PM. The Antitrust Modernization Commission (AMC) will meet. The topic will be "Antitrust in Regulated Industries". The witnesses will be Scott Alvarez, Ellen Hanson, Rob McKenna, Mark Cooper, Harold Furchtgott-Roth, Diana Moss, and John Thorne. See, AMC notice and notice in the Federal Register, November 16, 2005, Vol. 70, No. 220, at Page 69511. Location: Federal Trade Commission, Conference Center, 601 New Jersey Ave., NW.
The House will return from its Thanksgiving recess at 2:00 PM.
8:30 AM - 5:00 PM. Day one of a two day meeting of the National Institute of Standards and Technology's (NIST) Information Security and Privacy Advisory Board (ISPAB). The agenda includes the following items: (1) Privacy Act framework effort, (2) status reports on ISPAB work plan items, (3) briefing on NIST Next Generation Internet Protocol (IPv6), (4) briefing on NIST National Vulnerability Database Project, (5) NTIA Information Security Outreach Briefing, and (6) discussion of NIST's Cryptographic Hash Function Workshop. See, notice in the Federal Register, November 18, 2005, Vol. 70, No. 222, at Pages 69953 - 69954. Location: Doubletree Hotel and Executive Meeting Center, 1750 Rockville Pike, Rockville, MD.
9:00 AM. The Department of Commerce's (DOC) Bureau of Industry and Security's (BIS) Regulations and Procedures Technical Advisory Committee will hold a partially closed meeting. The agenda includes a discussion of the BIS's deemed export rules. See, notice in the Federal Register, November 23, 2005, Vol. 70, No. 225, at Page 70784. Location: Room 3884, Hoover Building, 14th Street between Constitution and Pennsylvania Avenues, NW.
TIME? The Department of Homeland Security's (DHS) Data Privacy and Integrity Advisory Committee will meet. Location: ___.
5:00 - 7:00 PM. The Public Knowledge will host an event titled "celebration of the season". RSVP by December 1, 2005 to aoliverio at publicknowledge dot org or 202 518-0020. Location: Suite 650, 1875 Connecticut Ave., NW.


The United States Food & Drug Administration (FDA) conducted an inspection at your dietary supplement firm, Rocky Road Formulas, located at 528 Leacrest Place W., Westerville, OH on May 22, May 28, July 8 and August 27, 2015. Based on the inspection, a review of the product labels collected during the inspection, and a review of your website at https://www.rockyforkformulas.com, we have identified serious violations of the Federal Food, Drug and Cosmetic Act (the Act) and applicable regulations. You may find the Act and the FDA’s regulations through links on FDA’s home page at www.fda.gov.
We received your written response letters on July 23, 2015 to the 483 issued on July 8, 2015. We have reviewed your response, and we address your proposed corrective actions below.
The FDA reviewed your website at the Internet address https://www.rockyforkformulas.com in March 2016 and has determined that you take orders there for the products Angio Fin, Arthritis Complex HS, EPA 1000, Gluco-Poise, Liver Complex, Niacin 500 Time-Released, Prostate Complex HS, Univase, Virex Complex. The claims on your websites establish that the products are drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act.
The name of your product is a drug claim.
Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. § 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.
A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. 353 § (b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.
Your products Adrenal Complex HS, Angio Fin, EPA 1000, Gluco-Poise, Prostate Complex HS, and Univase are intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, Angio Fin, EPA 100, Gluco-Poise, Prostate Complex HS, and Univase fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C. § 331(a)].
Your response indicates that your firm is currently researching name changes for some of your dietary supplements. However, your response is inadequate, because your products continue to be marketed as unapproved new drugs and a violation of the Act.
Even if your dietary supplements were not unapproved new drugs, they would still be adulterated dietary supplements under section 402(g)(1) of the Act. The inspection revealed significant violations of the CGMP requirements for dietary supplements. These violations cause your dietary supplement products to be adulterated under section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] in that they have been prepared, packed or held under conditions which do not meet the Current Good Manufacturing Practice (CGMP) regulations for dietary supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111).
1. You failed to establish specifications that provide sufficient assurance that the products you receive from a supplier for packaging or labeling as dietary supplements (and for distribution rather than for return to the supplier) are adequately identified and are consistent with your purchase orders, specifically, for those products purchased from SGT, NOW Foods and GRL that are formulated by those manufacturers, as required by 21 CFR 111.70(f).
Additionally, your response states that you have always had product specifications; however, you were unable to provide your product specifications during the inspection, nor were the specifications provided in your response, therefore we are unable to verify the adequacy of your response.
Once your have established specifications for products that you receive from a supplier for packaging or labeling as dietary supplements, you must verify that the specifications are met in accordance with 21 CFR 111.165(b) and 21 CFR 111.165(c), and you must make and keep records of such specification in accordance with 21 CFR 111.95(b)(1).
2. Your firm failed to establish a system of production and process controls and implement quality control operations to ensure the quality of your dietary supplements and that the dietary supplements are packaged and labeled as specified in the master manufacturing record as required by 21 CFR 111.65. Specifically, you do not have any quality control operations to oversee the packaging and holdings of your dietary supplements that are contract manufactured for your firm. Furthermore, you failed to establish and follow written procedures for the responsibility of quality control operations, including written procedures for conducting a material review and making a disposition decision, as required by 21 CFR 111.103.
Your response states you are currently developing a more stringent program to oversee and certify GMP practices. We are unable to evaluate the adequacy of your response because you did not provide written documentation showing how you plan to implement your quality control operations.
Your response states you have a procedure for product labeling but are developing a more stringent procedure for labeling unlabeled products. We are unable to evaluate the adequacy of your response because you did not provide written documentation showing how you plan to implement your packaging and labeling operations.
4. You failed to establish and follow written procedures to fulfill the requirements related to product complaints, as required by 21 CFR 111.553. Specifically, our investigators found that your firm failed to have written procedures to review customer complaints for dietary supplement products distributed by your firm.
Your response states you are developing a written procedure and appropriate forms for maintaining records of complaint. We are unable to evaluate the adequacy of your response because you did not provide written documentation showing how you plan to document and investigate product complaints.
5. Your firm failed to establish and follow written procedures to fulfill the requirements related to returned dietary supplements, as required by 21 CFR 111.503. Specifically, our investigators found that your firm failed to have a written procedure to review returned dietary supplement products distributed by your firm.
Your response indicated that you have had an unwritten return policy for many years. We are unable to evaluate the adequacy of your response because you failed to provide documentation of an established returned products procedure.
6. Your firm failed to collect and hold reserve samples of each lot of packaged and labeled dietary supplements that you distribute, as required by 21 CFR 111.83(a). Specifically, you do not collect and hold reserve samples of any of the dietary supplements that you distribute. You must collect and hold the required reserve samples in accordance with the requirements set forth in 21 CFR 111.83(b).
Your response indicated that you have implemented an interim policy for keeping reserve samples. We are unable to evaluate the adequacy of your response because you failed to provide documentation of your interim policy for keeping reserve samples.
Your Fibromyalgia Complex and Depression Complex products are in the form of capsules, but the label fails to declare capsule ingredients.
Your Fibromalate, Fibromyalgia Complex, Arthritis Complex HS and Arthrite product labels declare the dietary ingredient MSM, but this is not the common or usual name for this dietary ingredient.
Your Allergy Relief and Allerform product labels do not identify the species which are the sources of the omega-3 fish oil nor the sources of the lyophilized adrenal, pituitary, liver and parathyroid dietary ingredients.
2. Your Allerform, Allergy Relief, Arthrite, Arthritis Complex HS and Fibromalate, Vitamin B-15 products are misbranded within the meaning of section 403(q)(1)(A) of the Act [21 U.S.C. § 343 (q)(1)(A)], because the serving size declared on the labels is incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. For example, your Vitamin B-15 and Fibromalate product label directions of use suggest the consumer takes one or two capsules, but the serving size lists 1 capsule.
The following products list vitamins and/or minerals in the incorrect order and not in accordance with 21 CFR 101.36(b)(2)(i)(B): Andepress, Allergy Relief, Allerform, Fibromalate, Arthrite, Arthritis Complex HS, Fibromyalgia Complex and Depression Complex.
All (b)(2)-dietary ingredients must be listed above the (b)(3)-dietary ingredients, and separated by a heavy bar, in accordance with 101.36(e)(6).
Your Fibromalate, Andepress, Depression Complex, Fibromyalgia Complex, Allergy Relief and Allerform product labels do not identify the sources of all dietary ingredients in accordance with 21 CFR 101.36(d).
Your Arthrite, Arthritis Complex HS and Fibromyalgia Complex product labels do not state the percent Daily Value for the (b)(2)-dietary ingredient manganese in accordance with 21 CFR 101.36(b)(2)(iii).
Your Fibromyalgia Complex and Depression Complex product labels declare a quantitative amount of zero for (b)(2)-dietary ingredients sodium, total carbohydrate and protein and fail to comply with 21 CFR 101.36(b)(2)(i). Specifically, the (b)(2)-dietary ingredients shall not be declared if they are present in amounts that can be declared as zero in accordance with 21 CFR 101.9(c).
Your Fibromalate product label bears an incorrect percent Daily Value for chromium based on the listed amount, in accordance with 21 CFR 101.36(b)(2)(iii)(B).
4. Your Allerform, Allergy Relief, Andepress, Arthrite, Arthritis Complex HS, Fibromalate, and Vitamin B-15 products are misbranded within the meaning of section 403(r)(6)(C) of the Act [21 U.S.C. § 343(r)(6)(C)] because the labels appear to contain a disclaimer statement that is similar to the FDA disclaimer that is required with respect to structure function claims. The label disclaimer statement is not in compliance with the required wording and format as required in 21 CFR 101.93(c). We also note that product labels for product names that imply a structure function claim are required to contain the disclaimer statement per 21 CFR 101.93.
5. Your Allerform and Allergy Relief products are misbranded within the meaning of sections 403(q)(5)(F) and 403(s)(2)(A) of the FD&C Act [21 U.S.C. §§ 343(q)(5)(F) and 343(s)(2)(A)] in that the labels fail to list the name of each ingredient of the supplement that is described in section 201(ff) and the quantity of each such ingredient. For example, your labeling contains ingredient information to suggest that your product contains amino acids. You do not list the names of the specific amino acids in the Supplement Facts panel in accordance with 21 CFR 101.36(b)(3) and 101.4.
6. Your Vitamin B-15, Arthritis Complex HS, Fibromyalgia Complex, Allerform, Depression Complex, Arthrite, Fibromalate, Allergy Relief, Andepress products are misbranded within the meaning of section 403(s)(2)(B) of the Act [21 U.S.C. § 343(s)(2)(B)] because the labels fail to include a statement of identity as a “dietary supplement” as required by 21 CFR 101.3(g).
7. Your Andepress, Arthrite, Arthritis Complex HS, Depression Complex, Fibromalate and Fibromyalgia Complex products are misbranded within the meaning of section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)] because the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). For example, your Andepress and Depression Complex labels fail to include the part of the plant from which St. John’s wort is derived.
8. Your Depression Complex and Fibromyalgia Complex products are misbranded within the meaning of 403(y) of the Act [21 U.S.C. § 343(y)] because the labels fail to include a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplements. “Domestic address or domestic phone number” means a complete address or phone number. The labels for these two products do not include complete addresses or phone numbers.
This letter nor the FDA 483 are intended to be an all-inclusive list of the violations that may exist at your facility and with your products, labels, and labeling. It also does not indicate that FDA has conducted an all-inclusive review of all the products you manufacture and distribute. It is your responsibility to ensure the products you manufacture and distribute are in compliance with all applicable statutes and regulations, including the Act, the CGMP regulations for dietary supplements (21 CFR Part 111), and all applicable FDA labeling regulations.
You should take prompt action to correct all of the violations noted in this letter and establish and implement procedures that will prevent these and other violations in the future. Failure to implement lasting corrective actions may result in FDA taking regulatory action, such as seizure or injunction, without further notice.
Your Allerform, Allergy Relief, Andepress, Arthrite, Arthritis Complex HS, Depression Complex, Fibromalate, Fibromyalgia Complex, and Vitamin B-15 product labels bear the statement “based on a 2,000 calorie diet.” This statement is only permitted when the percent of Daily Value is declared for total fat, saturated fat, total carbohydrate, dietary fiber, or protein as required by 21 CFR 101.9(c) and 21 CFR 101.36(b)(2)(iii)(D). None of those dietary ingredients is present in amounts allowed to be declared on the label, so the statement is not permitted.
Your Allerform Allergy Relief, Andepress, Arthrite, Arthritis Complex HS, Depression Complex, Fibromalate, Fibromyalgia Complex, and Vitamin B-15 product labels bear the statement “RDA has not been established” or “RDI not established.” The correct statement is “DV has not been established,” “Daily Value not established,” or similar wording.
Your Allerform, Allergy Relief, Andepress, Arthrite,, Arthritis Complex HS, Fibromalate, and Vitamin B15 product labels bear the title “Also Contains.” The correct title of the ingredient statement is “Other ingredients” (to be used if some source ingredients are listed in the Supplement Facts) or “Ingredients” in accordance with 21 CFR 101.4(g).
Your Andepress product label bears an incorrect spelling for folic acid.
Section 743 of the Act [21 U.S.C. § 379j-31] authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including reinspection-related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determining whether compliance has been achieved. Reinspection-related costs means all expenses, including administrative expenses incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the re-inspection fees [21 U.S.C. § 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for reinspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any reinspection-related costs.
Your written response should be sent to the U.S. Food and Drug Administration, Allison C. Hunter, Compliance Officer, at the address noted in the letterhead. If you have questions, please contact Compliance Officer Hunter at (513) 679-2700 ext. 2134 or by email at allison.hunter@fda.hhs.gov.


058 Pa. Code § 115.8. Personnel requirements of passenger carrying boats.
§ 115.8. Personnel requirements of passenger carrying boats.
(a) It is unlawful for a person to operate a boat carrying passengers for hire unless the person first obtains an operators license for passenger carrying boats under § 115.9 (relating to licenses for operators).
(1) The length of the boat exceeds 45 feet.
(2) The boat is certified to carry more than 49 passengers.
(3) The operator cannot handle the mooring lines or associated equipment without assistance.
(1) Be at least 16 years of age.
(2) Be capable of performing the duties required.
(3) Possess a valid Boating Safety Education Certificate.
The provisions of this § 115.8 amended under section 5122 of the Fish and Boat Code (30 Pa.C.S. § 5122).
The provisions of this § 115.8 amended November 15, 2002, effective January 1, 2003, 32 Pa.B. 5659. Immediately preceding text appears at serial page (227700).


text:
This project unites four existing projects in wet tropical forests of Latin America. Coordinated annual vegetation censuses in long-term study plots will be conducted to test specific chronosequence predictions for a range of dependent variables. Our collaborative project began in 2007 and is funded for 10 years by the US National Science Foundation.
The Bosques Project, located in northeastern Costa Rica in and around La Selva Biological Station, was initiated in 1997 to investigate the factors that influence the spatial and temporal dynamics of seedling, sapling, and tree regeneration in second-growth forests. The project hopes to increase our knowledge of successional vegetation dynamics, and the use of secondary forests for forestry and biodiversity conservation.
NOTE: The available funding for this project covers only half of the actual cost of field research. The project urgently needs funds to continue. If you are interested in making a donation to this project please contact Robin Chazdon. Your financial support will make a difference!
Since 2008, together with Costa Rican researchers and with support from the blue moon fund, we have been monitoring trees in 18 0.5 ha forest monitoring plots in the Osa Biological Corridor in Costa Rica to evaluate changes in carbon storage and biodiversity during forest regrowth. We hope to expand this project to include studies of tree regeneration, tree functional traits, and remote sensing.
People and Reforestation in the Tropics, a Network for Education, Research, and Synthesis. PARTNERS is an NSF-funded Research Coordination Network that brings natural and social scientists together to address the complexity of socio-ecological processes that shape tropical reforestation. The 5-year project began in September 2013.
If you support the long-term research I am doing in Costa Rica, please consider making a donation to this project.
Front-page article on tropical deforestation and forest regeneration in the New York Times on Dec. 24, 2014 features my research and co-workers in Costa Rica.
Blog on "Advancing the role of natural regeneration in large-scale forest restoration"
My book "Second growth: Tropical forest regeneration in an age of deforestation" is available as an e-book, paperback, or hardcover from the University of Chicago Press. Portuguese translation to be published soon!
I am on leave from UConn for the 2015-2016 academic year and am a part-time Senior Research Associate with the International Institute of Sustainability in Rio de Janeiro, Brazil.
Tent-making bats, frugivory, and seed dispersal of mature forest species.
Baynes, J., J. Herbohn, R. L. Chazdon, H. Nguyen, J. Firn, N. Gregorio, D. Lamb. 2016. Effects of fragmentation and landscape variation on tree diversity in post-logging regrowth forests of the Southern Philippines. Biodiversity and Conservation (in press).
Poorter, L. F. Bongers, T. M. Aide, A. M. Almeyda Zambrano, P. Balvanera, J. Becknell, V. Boukili, P. H. S. Brancalion, E. N. Broadbent, R. L. Chazdon, D. Craven et al. 2016. Biomass resilience of Neotropical secondary forests. Nature 530: 211-214.
Menge, D. N. L., and R. L. Chazdon. 2015. Higher survival drives the success of nitrogen-fixing trees through succession in Costa Rican rainforests. New Phytologist 209: 965-977.
Magnuszewski, P., K. Ostasiewicz, R. L. Chazdon, C. Salk, M. Pajak, J. Sendzimir, K. Andersson. 2015. Resilience and alternative stable states of tropical forest landscapes under shifting cultivation regimes. PLoS ONE (in press).
Norden, N. H. A. Angarita, F. Bongers, M. Martínez-Ramos, I. Granzow-de la Cerda, M. van Breugel, E. Lebrija-Trejos, J. A. Meave, J. Vandermeer, G. B. W, B, Finegan, R. Mesquita, R. L. Chazdon. 2015. Successional dynamics in Neotropical forests are as uncertain as they are predictable. Proceedings of the National Academy of Science 112: 8013-8018.
Slik, F. et al. 2015. An estimate of the number of tropical tree species. Proceedings of the National Academy of Sciences 112:7472-7477.
Fagan, M. E., R. S. DeFries, S. E. Sesnie, J. P. Arroyo-Mora, C. Soto, A. Singh, P. A. Townsend, and R. L. Chazdon. 2015. Mapping species composition of forests and tree plantations in Northeastern Costa Rica with an integration of hyperspectral and multitemporal Landsat imagery. Remote Sensing 7:5660-5696.
Bongers, F., R. Chazdon, L. Poorter, and M. Peña-Claros. 2015. The potential of secondary forests. Science (New York, NY) 348:642.
Rozendaal, D. A. and Chazdon, R. L. 2015. Demographic drivers of tree biomass change during secondary succession in northeastern Costa Rica. Ecological Applications 25, 506-516.
Messier, C., K. Puettmann, R. Chazdon, K. Andersson, V. Angers, L. Brotons, E. Filotas, R. Tittler, L. Parrott, and S. Levin. 2015. From management to stewardship: viewing forests as complex adaptive systems in an uncertain world. Conservation Letters (in press).
Valle, D., B. Baiser, C. W. Woodall, and R. Chazdon. 2014. Decomposing biodiversity data using the Latent Dirichlet Allocation model, a probabilistic multivariate statistical method. Ecology Letters 17:1591-1601.
Chazdon, R. L. 2014. Second growth: The promise of tropical forest regeneration in an age of deforestation. University of Chicago Press, Chicago, IL. 449 pages.
Plourde, B. T., Boukili, V. K. and Chazdon, R. L. 2015. Radial changes in wood specific gravity of tropical trees: inter- and intraspecific variation during secondary succession. Functional Ecology 29, 111-120.
Lasky, J. R., M. Uriarte, V. K. Boukili, D. L. Erickson, W. J. Kress, and R. L. Chazdon. 2014. The relationship between tree biodiversity and biomass dynamics changes with tropical forest succession. Ecology Letters 17:1158-1167.
Sullivan, B. W., W. K. Smith, A. R. Townsend, M. K. Nasto, S. C. Reed, R. L. Chazdon, and C. C. Cleveland. 2014. Spatially robust estimates of biological nitrogen (N) fixation imply substantial human alteration of the tropical N cycle. Proceedings of the National Academy of Sciences 111:8101-8106.
Chazdon, R. L., B. Vilchez Alvarado, S. Letcher, A. Wendt, and U. U. Sezen. 2014. Effects of human activities on successional pathways: Case studies from lowland wet forests of Northeastern Costa Rica. Pp. 129-139 in Hecht, S., K. Morrison, and C. Padoch, Eds. The Social Life of Forests; Editors; University of Chicago Press.
Klos, P. Z., A. Chain-Guadarrama, T. E. Link, B. Finegan, L. A.Vierling, R. Chazdon. 2014. Throughfall heterogeneity in tropical forested landscapes as a focal mechanism for deep percolation. Journal of Hydrology 519: 2180-2188.
Lasky, J. R., M. Uriarte, V. K. Boukili, and R. L. Chazdon. 2014. Multiple effects of functional trait variation on tree community dynamics in tropical successional forests. Proceedings of the National Academy of Science 111: 5616-5621.
Sandor, M. E., and R. L. Chazdon. 2014. Remnant trees affect species composition but not structure of tropical second-growth forest. PLoS One 9:e83284.
Filotas, E., Parrott, L., Burton, P. J., Chazdon, R. L., Coates, K. D., Coll, L., Haeussler, S., Martin, K., Nocentini, S., Puettmann, K. J., Putz, F. E., Simard, S. W., Messier, C. 2014. Viewing forests through the lens of complex systems science. EcoSphere 5:art1.
Chazdon, R. L. and J. P. Arroyo. 2013. Tropical forests as complex adaptive systems. Pp. 35-59 in Messier, C., K J. Puettmann, and K. D. Coates, Eds. Managing forests as complex adaptive systems: Building resilience to the challenge of global change. Routledge, NY.
Chazdon, R. L. 2013. Regenerating tropical forest ecosystems. Pp. 277-286 in: Levin, S., Editor. Encyclopedia of Biodiversity, 2nd Edition, Volume 7. Academic Press, Waltham, MA.
Arroyo-Rodriguez, V., M. Ros, F. Escobar, F. P. L. Melo, B. A. Santos, M. Tabarelli, and R. Chazdon. 2013. Plant β-diversity in fragmented rain forests: testing floristic homogenization and differentiation hypotheses. Journal of Ecology 101: 1449-1458.
Chazdon, R. L. 2013. Strategies for landscape-scale restoration in the tropics. Journal of Sustainable Forestry 32:649–658.
Salk, C. F., R. L. Chazdon, and K. P. Andersson. 2013. Detecting landscape-level changes in above-ground tree biomass and biodiversity: Methodological constraints and challenges of plot-based approaches. Canadian Journal of Forest Research 43:799-808.
Norden, N., S. G. Letcher, V. Boukili, N. G. Swenson, and R. L. Chazdon. 2012. Demographic drivers of successional changes in phylogenetic structure across life history stages in tropical plant communities. Ecology 93 (Supplement): S70-S82.
Letcher, S. G., R. L. Chazdon, A. Andrade, F. Bongers, M. van Breugel, B. Finegan, S. G. Laurance, R. C. G. Mesquita, M. Martinez-Ramos, and G. B. Williamson. 2011. Phylogenetic community structure during succession: evidence from three Neotropical forest sites. Perspectives in Plant Ecology Evolution and Systematics 14: 79-87.
Chazdon, R. L., C. A. Harvey, M. Martínez-Ramos, P. Balvanera, K. E. Stoner, J. E. Schondube, L. D. Avila-Cabadilla, and M. Flores-Hidalgo. 2011. Seasonal dry forest biodiversity and conservation value in agricultural landscapes of Mesoamerica. Pages 195-219 in R. Dirzo, H. A. Mooney, G. Ceballos, and H. Young, editors. Ecology and Conservation of Neotropical Dry Forests. Island Press, Washington, D. C.
Jost, L., A. Chao, and R. L. Chazdon. 2011. Compositional similarity and β (beta) diversity. Pages 66-84 in A. E. Magurran and B. J. McGill, editors. Biological diversity: Frontiers in measurement and assessment. Oxford University Press, New York.
Norden, N., R. C. G. Mesquita, T. V. Bentos, R. L. Chazdon, and G. B. Williamson. 2011. Contrasting community compensatory trends in alternative successional pathways in central Amazonia. Oikos 120:143-151.
Antonarakis, A. S., S. S. Saatchi, R. L. Chazdon, and P. R. Moorcroft. 2011. Using Lidar and Radar measurements to constrain predictions of forest ecosystem structure and function. Ecological Applications 21:1120-1137.
Saatchi, S., M. Marlier, R. Chazdon, D. Clark, and A. Russell. 2011. Impact of spatial variability of tropical forest structure on radar estimation of aboveground biomass. Remote Sensing of Environment doi:10.1016/j.rse.2010.07.015.
Chazdon, R. L., A. Chao, R. K. Colwell, S.-Y. Lin, N. Norden, S. G. Letcher, D. B. Clark, B. Finegan, and J. P. Arroyo. 2011. A novel statistical method for classifying habitat generalists and specialists. Ecology 92:1332-1343.
DeClerck, F., R. Chazdon, K. Holl, J. Milder, B. Finegan, A. Martinez-Salinas, P. Imbach, L. Canet, and Z. Ramos. 2010. Biodiversity conservation in human-modified landscapes of Mesoamerica: Past, present and future. Biological Conservation 143:2301-2313.
Dubayah, R. O., S. L. Sheldon, D. B. Clark, M. A. Hofton, J. B. Blair, G. C. Hurtt, and R. L. Chazdon. 2010. Estimation of tropical forest height and biomass dynamics using lidar remote sensing at La Selva, Costa Rica. Journal of Geophysical Research 115:1-17.
Uriarte, M., N. G. Swenson, R. L. Chazdon, L. S. Comita, W. J. Kress, D. Erickson, J. Forero-Montaña, J. K. Zimmerman, and J. Thompson. 2010. Trait similarity, shared ancestry and the structure of neighbourhood interactions in a subtropical wet forest: implications for community assembly. Ecology Letters 13:1503-1514.
Vilchez Alvarado, B., R. L. Chazdon, and V. Milla Quesada. 2009. Dinámica de la regeneración en cuatro bosques secundarios tropicales de la región Huetar Norte, Costa Rica: Su valor para la conservación o uso commercial. Recursos Naturales y Ambiente no. 55: 118-128.
Norden, N., S. G. Letcher, V. Boukili, N. G. Swenson, and R. L. Chazdon. 2011. Demographic drivers of successional changes in phylogenetic structure across life history stages in tropical plant communities. Ecology in press.
Chazdon, R. L., A. Chao, R. K. Colwell, S.-Y. Lin, N. Norden, S. G. Letcher, D. B. Clark, B. Finegan, and J. P. Arroyo. 2011. A novel statistical method for classifying habitat generalists and specialists Ecology 92:1332-1343.
Chazdon, R. L., B. Finegan, R. S. Capers, B. Salgado-Negret, F. Casanoves, V. Boukili, and N. Norden. 2010. Composition and dynamics of functional groups of trees during tropical forest succession in northeastern Costa Rica. Biotropica 42:31-40.
Melo, F., B. Rodriguez-Herrera, R. L. Chazdon, G. Ceballos and R. Medellin. 2009. Small tent-roosting bats promote dispersal of large-seeded plants in a Neotropical forest. Biotropica 41: 737-743.
Letcher, S. G. and R L. Chazdon. 2009. Lianas and self-supporting plants during tropical forest succession. Forest Ecology and Management 257: 2150-2156.
Gardner, T., J. Barlow, R. L. Chazdon, R. Ewers, C. A. Harvey and N. S. Sodhi. 2009. Prospects for tropical forest biodiversity in a human-modified world. Ecology Letters 12: 561-582.
Norden, N., R. L. Chazdon, A. Chao, Y.-H. Jiang and B. Vilchez Alvarado. 2009. Resilience of tropical rain forests: Tree community reassembly in secondary forests. Ecology Letters 12: 385-394.
Sezen, U. U., R. L. Chazdon and K. E. Holsinger. 2009. Proximity is not a proxy for parentage in an animal-dispersed Neotropical canopy palm. Proc. Royal Soc. London B 276: 2037-2044.
Chazdon, R. L., C. Harvey, O. Komar, D. Griffith, B. Ferguson, M. Martínez-Ramos, H. Morales, R. Nigh, L.Soto-Pinto, M. van Breugel S. Philpott. 2009. Beyond reserves: A research agenda for conserving biodiversity in tropical human-modified landscapes. Biotropica 41: 142-153.
Chazdon, R.L. 2008. Beyond deforestation: Restoring forests and ecosystem services on degraded lands. Science 320: 1458-1460.
Chao, A., L. Jost, S. C. Chiang, Y.-H. Jian, and R. L. Chazdon. 2008. A two-stage probabilistic approach to multiple-community similarity indices. Biometrics 64: 1178-1186.
Chazdon, R. L. 2008. Chance and determinism in tropical forest succession. In: Carson, W. and S. Schnitzer, Eds. Tropical Forest Community Ecology. Wiley-Blackwell Publishing, pp. 384-408.
Dupuy, J. M. and R. L. Chazdon. 2008. Interacting effects of canopy gap, understory vegeation and leaf litter on tree seedling recruitment and composition in tropical secondary forests. Forest Ecology and Management 255: 3716-3725.
Harvey, C. A., O. Komar, R. Chazdon, B. G. Ferguson, B. Finegan, D. M. Griffith, M. Martinez-Ramos, H. Morales, R. Nigh, L. Soto-Pinto, M. van Breugel, and M. Wishnie. 2008. Integrating agricultural landscapes with biodiversity conservation in the Mesoamerican Hotspot. Conservation Biology 22: 8-15.
Sodhi, N. S., L. P. Koh, K. S.-H. Peh, H. T. W. Tan, R. L. Chazdon, R. T. Corlett, T. M. Lee, R. K. Colwell, B. W. Brook, C. H. Sekercioglu, and C. J. A. Bradshaw. 2008. Correlates of extinction proneness in tropical angiosperms. Diversity and Distributions 14: 1-10.
Vilchez, B., R. L. Chazdon, and W. Alvarado. 2007. Fenologia reproductive de las especies del dosel superior en seis sitions de la region Huetar Norte de Costa Rica. 2007. Kuru: Revista Forestal Costa Rica.
Sezen, U. U., R. L. Chazdon, and K. E. Holsinger. 2007. Multigenerational genetic analyses of tropical secondary regeneration in a canopy palm. Ecology 88: 3065-3075.
Chazdon, R. L., S. G. Letcher, M. van Breugel, M. Martinez-Ramos, F. Bongers and B. Finegan. 2007. Rates of change in tree communities of secondary Neotropical forests following major disturbances. Philosophical Transactions of the Royal Society B-Biological Sciences 362: 273-289.
Chao, A., R. L. Chazdon, R. K. Colwell and T. J. Shen. 2006. Abundance-based similarity indices and their estimation when there are unseen species in samples. Biometrics 62: 361-371.
Palomaki, M. B., R. L. Chazdon, J. P. Arroyo and S. G. Letcher. 2006. Juvenile tree growth in relation to light availability in second-growth tropical rain forests. Journal of Tropical Ecology 22: 223-226.
Lusk, C. H., Chazdon, R. L., and G. Hofmann. 2006. A bounded null model explains juvenile tree community structure along light availability gradients in an old-growth temperate rain forest. Oikos 112: 131-137.
Dupuy, J. M. and R. L. Chazdon. 2006. Effects of vegetation cover on seedling and sapling dynamics in secondary tropical wet forests in Costa Rica. Journal of Tropical Ecology 22: 65-76.
Ruiz, J., M. C. Fandino, and R.L. Chazdon. 2005. Vegetation structure, composition, and species richness across a 56-year chronosequence of dry tropical forest on Providencia Island, Colombia. Biotropica 37: 520-530.
Capers, R. S. R. L. Chazdon, Redondo Brenes, Al, and Vilchez Alvarado, B. 2005. Successional dynamics of woody seedling communities in wet tropical secondary forests. Journal of Ecology 93: 1071-1084.
Cardelus, C. L. and R. L. Chazdon. 2005. Inner-crown microenvironments of two emergent tree species in a lowland wet forest. Biotropica 37: 238-244.
Chazdon, R. L., A. Redondo Brenes, and B. Vilchez Alvarado. 2005. Effects of climate and stand age on annual tree dynamics in tropical second-growth rain forests. Ecology 86: 1808-1815.
Iriarte, S. B. B. and R. L. Chazdon. 2005. Light-dependent seedling survival and growth of four tree species in Costa Rican second-growth rain forests. Journal of Tropical Ecology 21: 383-395.
Vilchez Alvarado, R. L. Chazdon, and A. Redondo. 2004. Fenologia reproductiva de cinco especies forestales del Bosque Secundario Tropical. Kuru: Revista Forestal Costa Rica 1(2): 1-10.
Redondo Brenes, R. L. Chazdon, and B. Vilchez Alvarado. 2004. Effects of selective logging on dynamics and composition of woody seedlings in a tropical secondary forest. Kuru: Revista Forestal Costa Rica 1(3): 1-11.
Capers, R. S. and R. L. Chazdon. 2004. Rapid assessment of understory light availability in a wet tropical forest. Agricultural and Forest Meteorology 123: 177-185.
Chazdon, R. L. 2003. Tropical forest recovery: legacies of human impact and natural disturbances. Perspectives in Plant Ecology, Evolution and Systematics, 6: 51-71.
Chazdon, R. L., S. Careaga, C. Webb, and O. Vargas. 2003. Community and phylogenetic structure of reproductive traits of woody species in wet tropical forests. Ecological Monographs 73: 331-348.
Chazdon, R. L. and T. C. Whitmore. 2002. Foundations of Tropical Forest Biology: Classic Papers with Commentaries. University of Chicago Press.
Montgomery, R. A. and R. L. Chazdon. 2002. Light gradient partitioning by tropical tree seedlings in the absence of canopy gaps. Oecologia 131: 165-174.
Drake, J. B., R. O. Dubayah, D. B. Clark, R. G. Knox, J. B. Blair, M. A. Hofton, R. L. Chazdon, J. F. Weishampel, and S. Prince. 2002. Estimation of Tropical Forest Structural Characteristics Using Large-footprint Lidar.? Remote Sensing of Environment. 79: 305-319.
Redondo B., A., B. Vilchez A., R. L. Chazdon. 2001. Estudio de la dinamina y composicion de cuatro bosques secundarios en la region Huetar Norte, Sarapiqui--Costa Rica. Revista Forestal Centroamericana No. 36 (Oct-Dec) 21-26.
Montgomery, R. A. and R. L. Chazdon. 2001. Forest structure, canopy architecture, and light transmittance in old-growth and second-growth tropical rain forests. Ecology 82: 2707-2718.
Chazdon, R. L., R. K. Colwell, and J. S. Denslow. 1999. Tropical tree richness and resource-based niches. Science 285: 1459a [on-line journal only].
Chazdon, R. L. and F. G. Coe. 1999. Ethnobotany of woody species in second-growth, old-growth, and selectively logged forests of northeastern Costa Rica. Conservation Biology 13: 1312-1322.
Nicotra, A. B., R. L. Chazdon, and S. Iriarte. 1999. Spatial heterogeneity of light and woody seedling regeneration in tropical wet forests. Ecology 80: 1908-1926.
Canham, C. D., R. K. Kobe, Latty, E. F. Chazdon, R. L. 1999. Interspecific and intraspecific variation in tree seedling survival: effects of allocation to roots versus carbohydrate reserves. Oecologia 121: 1-11.
Dupuy, J. M. and R. L. Chazdon. 1998. Long-term effects of forest regrowth and selective logging on the seed bank of tropical forests in NE Costa Rica. Biotropica 30: 223-237.
Butler, B. J. and R. L. Chazdon. 1998. Species richness, spatial variation, and abundance of the soil seed bank of a secondary tropical rain forest. Biotropica 30: 214-222.
Guariguata, M. R., R. L. Chazdon, J. S. Denslow, J. M. Dupuy and L. Anderson. 1997. Structure and floristics of secondary and old-growth forest stands in lowland Costa Rica. Plant Ecology 132: 107-120.
Nicotra, A. B., R. L. Chazdon and C. D. Schlichting. 1997. Patterns of genotypic variation and phenotypic plasticity of light response in two tropical Piper (Piperaceae) species. American Journal of Botany 84: 1542-1553.
Kabakoff, R. P. and R. L. Chazdon. 1996. Effects of canopy species dominance on understory light availability in tropical secondary rain forest. Journal of Tropical Ecology 12: 779-788.
Chazdon, R. L., R. K. Colwell, J. S. Denslow and M. Guariguata. 1998. Statistical estimation of species richness of woody regeneration in primary and secondary rainforests of NE Costa Rica. . Pp 285-309 In: Dallmeier, F., and J. Comisky, eds. Forest Biodiversity in North, Central, and South America and the Caribbean: Research and Monitoring. Parthenon Press, Paris.
Chazdon, R. L., R. W. Pearcy, D. W. Lee and N. Fetcher. 1996. Photosynthetic responses to contrasting light environments. pp. 5-55 in: Mulkey, S., Chazdon, R. and Smith, A. P. (eds.) Tropical Forest Plant Ecophysiology, Chapman and Hall.

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