You asked about the history of constitutional conventions in Connecticut and the process involved in undertaking and conducting a convention.
State legislatures have the power to call constitutional conventions even when authority is not specifically granted by the state constitution. In Connecticut, the General Assembly called the first constitutional convention in 1818, but it was not until the 1965 constitutional convention that the process for calling a convention was set in law.
Today, a constitutional convention can be called by a vote of two-thirds of each house of the General Assembly at least 10 years after the last convention. Alternatively, the General Assembly must call a convention when a majority of voters approve a general election ballot question posed at least 20 years after the last convention or ballot question. The General Assembly is responsible for choosing the membership and dates for a convention. Proposed amendments or revisions must be submitted to the electors within two months of the convention's final adjournment.
Historically, state legislatures have had the power to call a constitutional convention even if the state constitution does not provide for one, or they may submit to the people the question of calling a convention (16 C.J.S. Constitutional Law § 29).
The first constitutional convention in Connecticut, called by the legislature, was held in 1818. The convention was not open to the public, and the official Journal of the Constitutional Convention of Connecticut, Held at Hartford in 1818 (1873) provides only brief minutes and voting records. Reports from The Connecticut Currant (later The Hartford Courant) and The Connecticut Journal (later The New Haven Register) include details about the debates and the results of the roll call votes. The 1818 convention yielded the Constitution of 1818, which replaced the Fundamental Orders of 1639 and introduced a new mode of governance, including a Declaration of Rights that limited the role of the state in religion (Paula G. Shakelton, Remembering What Cannot Be Forgotten, 52 Emory L.J. 997 (Spring 2003), Wesley Horton, Annotated Debates of the 1818 Constitutional Convention, 65 Conn. B.J. SI-3 (1991)).
In 1902, another constitutional convention met to discuss reapportionment, but the proposal was rejected (http://www.cslib.org/cts4ch.htm).
In 1965, a constitutional convention was convened, focusing on its mandate: reapportionment. A 1964 U.S. Supreme Court case had established the “one person, one vote” principle, and a federal district court orderd a convention in Connecticut to revise the districting plan for the General Assembly (Reynolds v. Sims, 377 U.S. 533; Butterworth v. Dempsey, 237 F. Supp. 302 (D. Conn.), affirmed, 378 U.S. 564 (1964)). Beyond that, the convention fine-tuned the 1818 Constitution. References to Christianity were eliminated; a broader equal protection clause was added; the Supreme Court of Errors became the Supreme Court; the governor was given revised veto powers; a section on free public education was added; and Article 13, a provision establishing the process for future constitutional conventions, was added.
On a roll call vote, with support of two-thirds of the total membership of each house, the General Assembly may call a constitutional convention to amend the state constitution at least 10 years after the date of a prior convention (Conn. Const. Art. 13, § 1).
A convention must be held if approved by voters pursuant to a ballot question that must appear at specified times. Voters are asked, “Shall there be a Constitutional Convention to amend or revise the Constitution of the State?” at the general election in the even-numbered year at least 20 years from the date of the last convention or the last date that question appeared on the ballot, whichever date is most recent. If a majority of voters voting on the question approves the measure, the General Assembly follows the constitutional process for convening the convention (Conn. Const. Art. 13, § 2).
With a favorable vote of at least two-thirds of the total membership of each house, the General Assembly then stipulates the (1) manner of selecting the convention's membership; (2) date of convening, which must be within one year from the date of the roll call vote or general election; and (3) date of its final adjournment (Conn. Const. Art. 13, § 3).
The convention's proposals to amend or revise the constitution must be submitted to all the electors of the state by two months after its final adjournment. If a majority of the voters voting on the question approves the proposal, it becomes part of the constitution, taking effect 30 days after the vote, unless otherwise provided (Conn. Const. Art. 13, § 4).


Re: Response to the FDA-Warning Letter 14-PHI-03 received on February 3rd, 2014.
This is our response to the FDA-Warning Letter 14-PHI-03 that we received on Monday February 3rd, 2014. In this letter we will offer detailed responses to each observation and provide supporting documentation. Before we offer our detailed responses, we would like to provide some Insight into the work that we have already completed to address the deficiencies that were cited in the Form FDA 483 dated March 21st, 2013. We respectfully request that this response be posted online along with the Warning Letter.
The inspection in 2013 was the first FDA inspection of our facility. Since that time we have taken steps to correct the deficiencies cited in the Form FDA 483. As you will read, we have implemented improvements Standard Operating Procedures (SOPs) to address the calibration and complaint handling deficiencies and we have also concluded our investigation into the Certificate of Analysis issue regarding Androbolix Lot #C071185. Also, after the inspection, we enrolled our new Chief Operations Officer (COO) and Quality Control Manager (QCM) in the following NSF courses: 21 CFR 111 Dietary Supplement GMP Overview, Vendor Qualification & Audit Training, SOP & Record Keeping, and FDA Inspection Readiness. They also attended two (2) speaking presentations given by Dr. Fabricant, the Director, Division of Dietary Supplement Programs. We strive to be compliant with all FDA regulations and FDA Guidance Documents, so continued education and training of our personnel is an example of our commitment to quality and compliance to 21 CFR 111. We have included their certificates of attendance at these NSF cGMP courses for your review. [see APPENDIX A].
Furthermore, we have worked to address all of the deficiencies related to the Master Manufacture Records (MMRs) and product specifications. As part of these improvements, we are reformulating and re-labeling all of our products. All production on our current products will cease on March 31st, 2014, and the first of our new products will begin production on April 7th, 2014. As you will read, we have created product specifications and MMRs that are compliant with 21 CFR 111.70. We have included a copy of a few of these specifications along with an MMRs for your consideration. We have also included detailed information as to specification limits for identity, purity, strength, and composition and the testing that will be used to determine if the specifications have been met.
We reviewed your website at the Internet address http://biorhythm-ads.com/index.cfm In January 2014, and we have determined that you take orders there for your BioRhythm Olio and ReGenerate products, which the website promotes for conditions that cause the products to be drugs under section 201(g)(1)(B) of the Act [21 U.S.C.§ 321 (g)(1)(B)]. The therapeutic claims on your website establish that the products are drugs 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.
• "Supports reduction of 'bad' cholesterol"
• "Research Indicates a diet that includes olive oil yields less overall disease and lower mortality rates"
• "Supports reduction of "bad" cholesterol"
• "Decrease bone fracture healing time and lessen joint pain"
• "Cissus Quadrangularis [an ingredient in the product] ... has already proven to be an excellent healing aid by significantly reducing the average recovery time in major injuries as well as reducing the pain associated with minor tears or inflammation"
Your BioRhythm Olio and ReGenerate 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)(1) of the Act [21 U.S.C. § 321 (p)(1)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in section 505(a) of the Act [21 U.S.C § 355(a)]; see also section 301(d) of the Act [21 U.S.C. § 331(d)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.
Furthermore, your BioRhythm Olio product is offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use the drug safely for its intended purposes. Thus, your BioRhythm Olio product is misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. §352(f)(1)], in that its labeling fails to bear adequate directions for use. The introduction of a misbranded drug into Interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)].
We take extreme care to ensure that the statements on our labels are not misleading. After reading Warning letter 14-PHI-03, we reviewed our website at the Internet address http://biorhvthmads.com/index.cfm. We are pleased to report that all of the statements mentioned in Warning letter 14-PHI-03 have been removed. we have provided screen shots of the pages and tabs from our website as verification [see APPENDIX B).
During the inspection, our Investigators collected labeling for your BioRhythm Androbolix product, which you market as a dietary supplement. The labeling for this product declares 4-etioallocholen-3,6, 17-trione as a dietary ingredient. The term "dietary supplement is defined in section 201(ff) of the FD&C Act [21 U.S.C. § 321 (ff)]. Assuming that 4-etioallocholen-3,6, 17-trione is a dietary ingredient under section 201 (ff)(1) of the Act, it would also be a "new dietary ingredient for which a notification is required under section 413(a)(2) of the Act [21 U.S.C. § 350b(a)(2)] and 21 CFR 190.6.
2. There is a history of use or other evidence of safety establishing that the dietary ingredient, when used under the conditions recommended or suggested In the labeling of the dietary supplement, will reasonably be expected to be safe and, at least 75 days before being introduced or delivered for introduction into interstate commerce, the manufacturer or distributor of the dietary ingredient or dietary supplement provides FDA with information, including any citation to published articles, which is the basis on which the manufacturer or distributor has concluded that a dietary supplement containing such dietary ingredient will reasonably be expected to be safe.
The ingredient 4-etioallocholen-3,6,17-trione was only used as an ingredient in our original formulation of Androbolix. We have provided a copy of the original Androbolix label along with its formula for your consideration [see APPENDIX C). In February of 2011, we began offering a reformulated version named Androbolix300 and started phasing out Androbolix. The formulation for Androbolix300 does not contain the ingredient 4-etioallocholen-3,6,17-trione. We have provided a copy of the Androbolix300 label along with its formula for your consideration [see APPENDIX C].
Our Androbolix product was officially discontinued on November 30th, 2012 and any remaining units, and bulk capsules were destroyed on that day. After reviewing our inventory report for these items, you will see that we do not have any Androbolix units in our inventory with the exception of the units that we kept for retains in accordance with 21 CFR 111.80 and 111.83. We have provided copies of our inventory records for these items along with the material destruction logs for the remaining units. [see APPENDIX C]. We have not distributed Androbolix or any other products containing 4-etioallocholen-3,6,17-trione since November 30th, 2012.
Even if your BioRhythm Olio and ReGenerate products did not have therapeutic claims which make them unapproved new and misbranded drugs, these products would be adulterated dietary supplements within the meaning of section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] because the products have been prepared, packed, or held under conditions that 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) these. In addition, your BioRhythm Androbolix 300, Androbolix, Whole Gains Mango, Olio, and ReGenerate products are adulterated dietary supplements within the meaning of section 402(g)(1) of the Act for the same reason.
As a distributor that contracts with other manufacturers to manufacture dietary supplements that your firm releases for distribution under your firm's name, your firm has an obligation to know what and how these activities are performed so that you can make decisions related to whether the products conform to established specifications and whether to approve and release the products for distribution [72 Fed. Reg. 34752, 34790 (June 25, 2007)]. Your firm introduces or delivers, or causes the introduction or delivery, of dietary supplements into interstate commerce for distribution to consumers. As such, your firm has an overarching and ultimate responsibility to ensure that all phases of the production of that product are in compliance with dietary supplement CGMP requirements.
1. You did not establish product specifications for the identity, purity, strength, and composition of your finished dietary supplements, and for limits on those types of contamination that may adulterate, or that may lead to adulteration of, the finished batch of dietary supplements, as required by 21 CFR 111.70(e). Specifically, during the inspection, you stated that you create and approve product formulations, which you provide to other manufacturers for the manufacture of your products In bulk. You also stated that you do not provide any additional specifications for the products. Further, in your response letter, dated April 10, 2013, you provided a Standard Operating Procedure (SOP) entitled "Specifications Setting Policy," which specifies that "Exclusive Supplements must establish specifications for the finished batch of the dietary supplement." While you stated that your firm will review the specifications that you have in place for finished products and establish finished product specifications where necessary, you failed to provide documentation of such finished product specifications. As such, we are unable to determine the adequacy of your proposed corrective actions at this time.
Improving our product specifications and MMRs have been our firm's top priority. We have written a new SOP for Specifications (ESI-SOP-019) that is compliant with 21 CFR section 111.70, 111.77, and 111.90. We have included a copy of ESI-SOP-019 for your consideration [see APPENDIX D). As you will read, ESI-SOP-019 requires that we establish written specifications for the Identity, purity, strength, and composition of every finished batch of every dietary supplement. Specifications must also be established for the limits of those types of contaminants that may adulterate, or that may lead to adulteration of, the finished batch of the dietary supplement.
We have been working on reformulating and relabeling our entire product line since May of 2013. On March 31st, 2014 all production of our current products will be discontinued. Production on our new reformulated products is slated to begin on April 7th, 2014. All products packaged, labeled, and distributed by ESI after March 31st, 2014, will be in accordance with SOP ESI-019. We have included a copy of one of these specifications for our finished dietary supplements for your consideration [see APPENDIX E). We have also written a new SOP for the sampling of all incoming materials (ESI-SOP-020). As part of ESI-SOP-020, we have developed testing schedules for each incoming material utilizing ANSI/ASQ Z1.4 tables to ensure a statistically sound testing program. We have included a copy of ESI-SOP-020 for your consideration [see APPENDIX F).
2. You did not prepare a written Master Manufacturing Record (MMR) related to your packaging and labeling operations, as required by 21 CFR 111.205. An MMR must include, among other things, the identity and weight or measure of each dietary Ingredient that will be declared on the Supplement Facts label and the identity of each ingredient that will be declared on the Ingredients list of the dietary supplement and a description of packaging and a representative label, or cross-references to the physical location of the actual or representative label (21 CFR 111.210). However, your firm did not prepare an MMR for the packaging and labeling operations conducted at your firm. We note the records provided as part of your firm response, dated April 10, 2013, are Batch Product Records and not MMRs. You must prepare MMRs for each of your products for the operations you perform.
As we stated before, improving our product specifications and MMRs have been our firm's top priority. We have written a new SOP for MMRs (ESI-SOP-026) that is compliant with 21 CFR section 111.205 and 111.210. We have included a copy of ESI-SOP-026 for your consideration [see APPENDIX G]. As you will read, ESI-SOP-026 requires that we document the identity and weight or measure of each dietary ingredient that will be declared on the Supplement Facts label, and the identity of each ingredient that will be declared on the ingredients list of the dietary supplement. ESI-SOP-026 also requires a description of packaging and a representative label.
As we stated before, we have been working on reformulating and relabeling our entire product line since May of 2013. On March 31st, 2014 all production of our current products will be discontinued. Production on our new reformulated products is slated to begin on April 7th, 2014. All products packaged and labeled by ESI after March 31st, 2014, will be in accordance with ESI-SOP-026. We have also included a copy of a MMR for your consideration [see APPENDIX H).
3. You did not establish specifications to sufficiently assure that the product you receive for packaging and labeling as a dietary supplement is adequately identified and is consistent with your purchase order, as required by 21 CFR 111.70(f). Specifically, you stated during the inspection that you do you do not have written specifications for the packaging and labeling of your dietary supplement products, packaging, or labels that you receive for packaging and labeling. You also stated that you perform a visual examination of incoming products, but you stated that you do not document the visual examination you perform of incoming products. We note that a visual examination generally cannot sufficiently assure that dietary supplement products are adequately identified and consistent with your purchase order as a visual examination only provides information about the appearance of a product and such information alone generally cannot be used to verify the identity of product, particularly a product in capsule or tablet form.
We have reviewed your response letter, dated April 10, 2013, and determined your response to be inadequate. Your response states that you "will review the specifications [you] have in place for product [you] receive for packaging and labeling as a dietary supplement. Where necessary, these will be revised, approved and implemented." However, you have not provided FDA with any documentation of such specifications, including those you have in place. As such, we are unable to determine the adequacy of your proposed corrective actions at this time.
It should be noted that we do not blend our various powders in-house. We receive blended powders from contract manufacturers. Confirming the identity of a blended powder is not as straightforward as establishing the identity of a single pure ingredient. In 2013, we began looking for the most appropriate method for identity testing for our various blended powder and capsule products. A feasibility study was conducted by Bruker Optics to determine which method would provide the most reliable results. It was concluded that Fourier Transform Near lnfared Analysis (FT-NIR) is the most suitable analysis for blended powders and capsules. We have included a copy of the feasibility study and supporting information for your consideration [see APPENDIX 1]. We have purchased a new Bruker Optics MATRIX-1-FT-Near Infrared Spectrometer unit and we are awaiting delivery.
4. Your quality control personnel approved and released for distribution product received from a supplier for packaging and labeling as a dietary supplement for which sufficient assurance was not provided to adequately identify the product to determine that the product Is consistent with your purchase order, as required by 21 CFR 111.123(b)(4). Specifically, two products that you receive from a supplier for packaging and labeling are similar in name: BioRhythm Androbolix 300 capsules and BioRhythm Androbolix capsules. Your quality control personnel approved and released for distribution your BioRhythm Androbolix 300 capsules, lot# (b)(4), which you received from your contract manufacturer on 8/20/11. However, the Certificate of Analysis (COA) for this product lists ingredients that are not listed in your Androbolix 300 product Master Formula or product label. Rather, the ingredients listed on this COA are the ingredients listed In the Master Formula and product label for the other product, BioRhythm Androbolix capsules. Lot# (b)(4) was used to repack and label a total of (b)(4) - 120 capsule bottles of Androbolix 300 with finished product lot# (b)(4) and lot# (b)(4).
We note your firm's response, dated April 10, 2013, concludes that the product received for packaging and labeling as Androbolix 300 was, indeed, Androbolix 300; your conclusion is that the COA included typographical errors. You base this conclusion on the fact that the product you received had the appropriate visual characteristics, namely color. You also submitted documentation in the form of a Master Batch Record from your contract manufacturer for your Androbolix 300 product. However, the listing of ingredients in this batch record further calls into question the identity of the product in that the ingredients are not consistent with either the Androbolix 300 Master Formula or the product label. Further, you did not submit the complete Batch Product Record, and there is no information as to how this product was manufactured or any other information that would assist in determining the Identity of this product, such as results of identity testing. Reliance upon visual characteristics is not adequate to verify the identity and ensure quality of a dietary supplement product.
Furthermore, we note that the violations described above with respect to not preparing MMRs for your packaging and labeling operations under 21 CFR 111.205, not establishing specifications under 21 CFR 111.70(f), and the failures in your quality control operations under 21 CFR 111.123(b)(4) to ensure the products you receive from contract manufacturer(s) are consistent with your purchase order demonstrate a pervasive problem with your facility's operations. It is critical that your firm have a system of production and process controls in place along with sufficient quality control operations to ensure the quality of your dietary supplements and that the dietary supplements are packaged and labeled as specified in the MMR (21 CFR 111.55 and 111.65). MMRs, applicable specifications, and quality control measures that relate specifically to your packaging, labeling and distribution operations are necessary to ensure the quality of your dietary supplement products, and to be compliant with the regulations under 21 CFR Part 111.
We assure you that we have taken this incident with the utmost seriousness. Upon being made aware of this incident, we contacted our customers who had purchased lot #C071185 in an attempt to retrieve any units that could still be in circulation. Lot #C071185 of Androbolix300 was bottled on September 7th of 2011, so it is not surprising that we were unable to locate a single bottle of lot #C071185 in circulation.
We also contacted the contract manufacturer that produced lot #C071185. The contract manufacturer provided us with a copy of their Batch Production Record (BPR) for lot # C071185 and asserted that it was simply a typographical error on the Certificate of Analysis that caused the information from Androbolix to be listed on the documentation for Androbolix300. We feel that this oversight should have been detected by ESI but also by the contract manufacturer, so we immediately discontinued the use of this contract manufacturer for our Androbolix300 product. On March 16th, 2013, we began purchasing Androbolix300 from another contract manufacturer.
We agree with the FDA that relying on the contract manufacturer's BPR and visual verification were not sufficient. We began looking for a way to scientifically prove that lot # C071185 was Androbolix300 and not Androbolix. We determined that the best way to differentiate between the two formulas would be to test for an ingredient that would be present in Androbolix300 and not in Androbolix. While there are several differences between the two formulas, we determined that the most obvious difference is that Eurycoma Longofolia is present in Androbolix300 but not in Androbolix. If we were to detect the presence of Eurycoma Longofolia In Lot #C071185 it would confirm that it was Androbolix300 and not Androbolix. We contracted Alkemist Labs to perform the analysis. We sent Alkemist Labs samples of both Androbolix and Androbolix300 along with Lot #C071185 of Androbolix300. They analyzed the samples using High Performance Thin-Layer Chromatography and concluded that Eurycoma Longofolia was present in Androbolix300 Lot #C071185. We feel that these analyses results confirm that Lot #C071185 was indeed Androbolix 300. We have included the results from these tests for your consideration. [see APPENDIX J]. On September 30th, 2013, after reviewing the findings of Alkemist Labs, we concluded our investigation into this incident.
1. Any batch of dietary supplement for which any component In the batch does not meet its identity specification.
2. Any batch of dietary supplement, including any reprocessed batch which does not meet all product specifications.
3. Any batch of dietary supplement, including any reprocessed batch which has not been manufactured, packaged, labeled, and held under conditions to prevent adulteration.
4. Any product received from a supplier for packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier) for which sufficient assurance is not provided to adequately identify the product and to determine that the product is consistent with the purchase order.
• A serious adverse event, dated 2/19/13, regarding BioRhythm brand Whole Gains Protein Watermelon in which the complainant experienced a rapid heart rate and dizziness after using the product.
• A serious adverse event, dated 4/5/11, regarding BioRhythm brand Olio softgels in which the complainant experienced rectal bleeding.
Furthermore, you failed to make and keep records related to product complaints, as required by 21 CFR 111.570. Specifically, you stated during the inspection that you remembered Investigating two complaints related to your BioRhythm brand product, AfterGlow, in which the complainants stated that the product did not mix, and that the product tasted like sour milk; however, you did not document the investigation. You must investigate product complaints and document the investigation in order to comply with 21 CFR 111 Subpart O - Product Complaints.
We have since adopted an improved SOP for handling of customer complaints that is compliant with 21 CFR 111.560 (ESI-SOP-036). As part of the new SOP, any customer service personnel that receives a complaint must gather initial information regarding the incident. This information is then given in writing to the Quality Control Manager. We have attached copies of ESI-SOP-036 along with a copy of a completed complaint record for your consideration [see APPENDIX L].
A. A qualified employee of the Quality Unit must review each consumer complaint to determine whether the complaint involves a possible failure of a dietary ingredient or dietary supplement to meet any of its specifications, or any other requirements which may render the product non-conforming, and a possible risk of illness or injury to the consumer.
B. The Quality Unit must review and approve decisions to investigate a product complaint, and they must review and approve the findings and follow-up action of any investigation performed.
C. Review, investigations, and follow-up action for product complaint must extend to all relevant batches and records.
D. If the review indicates that the product is a possible risk to consumer safety, the consumer complaint must be fully investigated, and the need to recall the product must be evaluated.
E. The investigator must review the batch records associated with the dietary supplement involved in the consumer complaint. In addition, the investigator must review batch records for other dietary supplements that may have also been affected and could also pose a threat to consumer safety.
F. The Quality Unit must maintain a written record of every consumer complaint, whether the complaint relates only to product quality, or to concerns about a possible health hazard.
6. You did not make and keep documentation of calibrations for instruments or controls that you use in manufacturing or testing a component or dietary supplement as required by 21 CFR 111.35(b)(3). Specifically, you do not document that your scales have been calibrated.
In September of 2013 we implemented our Equipment Calibration (ESI-SOP-017) that is compliant with 21 CFR sections 111.25, 111.27, 111.30, and 111.35. We have attached a copy of ESI-SOP-017 along with our calibration log sheets for your consideration [see APPENDIX M]. Furthermore, all of our scales have been calibrated by WISCO calibration Services and their accuracy is now tested on a weekly basis. It should also be noted that our improved MMRs document which ESI scales are used at every step during our packaging and labeling process.
Your BioRhythm brand Androbolix 300, Androbolix, and Whole Gains Mango dietary supplement products are misbranded under section 403 of the Act [21 U.S.C. § 343] in that the labeling for these products does not comply with labeling requirements for dietary supplements, including FDA's regulations under 21 CFR Part 101. In addition, even if your BioRhythm Olio and ReGenerate products did not have therapeutic claims, which make these products unapproved and new misbranded drugs, they would also be misbranded for the same reason.
• Your BioRhythm brand Androbolix 300 label does not list zinc, niacin and Vitamin B6 in the correct order. Niacin, vitamin B6 and zinc should be listed in that order before the other dietary ingredients in accordance with 21 CFR 101.36(b)(2) and 101.36(b)(3).
• In accordance with 21 CFR 101.36(b)(2)(ii)(B), your Whole Grains Protein label fails to include the total quantitative amount by weight per serving for dietary ingredients declared under 21 CFR 101.36(b)(2)(i)(B) using the units of measurement and the levels of significance given in § 101.9(c)(8)(iv). Furthermore, the enzymes declared on the label should not be listed after the terms "Ingredients" or "Other Ingredients". The enzymes Pancreatin; amylase, protease, and lipase should be declared using their common or usual name and listed with their quantitative amount by weight per serving in metric units in the nutrition information within the Supplement Facts panel in accordance with 101.36(b)(3).
• Your Whole Grains Protein label fails to declare the dietary ingredients iodide, chloride, and potassium, their amounts in one serving of the product, and the percent of the daily value. Vitamins or minerals listed in 101.9(c)(8)(iv) shall be declared when they are added to the product for purposes of supplementation, or when a claim is made about them. Your label makes the claim to contain potassium iodide and potassium chloride.
the Supplement Facts box in accordance with 21 CFR 101.4(g).
• Your Androbolix and Androbolix 300 labels fail to include the part of the plant from which Tribulus is derived.
• Your Androbolix 300 label fails to include the part of the plants from which Eurycoma longifolia and Cimicifuga racemosa are derived.
In regards to Androbolix and Androbolix 300 labels, as we stated previously we have discontinued production of Androbolix in November of 2012. As of March 30th, 2014, the Androbolix300 will no longer be produced and is being replaced with Androbolix300-XL. We have corrected these issues on our new label for Androbolix300-XL. We have attached a copy of the label proof for the Androbolix300-XL for your consideration [see APPENDIX N]. As you will read, the Androbolix300-XL label list zinc, Niacin, and Vitamin B6 in the correct order in accordance with 21 CFR 101.36(b)(2) and 101.36(b)(3). The Androbolix300-XL label also clearly lists the part of the plant from which the Tribulus, Eurycoma Longifolia, and Cimicifuga racemosa are derived in accordance with CFR 101.4(h).
In regards to our Whole Gains Mango label, as of March 30th, 2014, we will no longer produce our Whole Gains Mango product using its current label. Production will resume for this product after April 7th, 2014 with a new formulation and a new label. The new Whole Gains label will include the total quantitative amount by weight per serving for dietary ingredients declared under 21 CFR 101.36 (b)(2)(i)(B). The new label will also include the amount of iodide, chloride, and potassium along with their Daily Value. The other ingredients will also be listed outside of the Supplement Facts box in accordance with 21 CFR 101.4(g). We will update the FDA with a label proof once it has been completed and approved.
In regards to our Olio and Regenerate labels, as of March 30th, 2014, we will no longer produce either of these products using their current labels. Production will resume after April 7th, 2014 with new formulations and new labels. The other ingredients will be listed outside of the Supplement Facts box in accordance with 21 CFR 101.4(g). We will update the FDA with a label proof once it has been completed and approved.
• A serious adverse event, dated 4/5/11, regarding BioRhythm brand Olio softgels in which the complainant experience rectal bleeding.
As we stated before, we have since adopted an improved SOP for handling of customer complaints that is compliant with 21 CFR 111.560 (ESI-SOP-036) [see APPENDIX L]. ESI-SOP-036 requires the Quality Control Manager to review and investigate all complaints to determine if there is a failure of a dietary supplement to meet any of its specifications, or any other requirements of 21 CFR 111, including those specifications and other requirements that, if not met, may result in a risk of illness or injury and determine if the incident warrants reporting to FDA Med Watch.
It should be noted that, since receiving the FDA Form 483 on March 21st, 2013, we have reported two (2) adverse events to Med Watch in accordance with ESI-SOP-036. It should also be noted that, although it was outside of the required fifteen (15) day period, we have since reported the above referenced incidents to MedWatch.
1. You state on page (b)(4) of your Standard Operating Procedures Manual (under the subheading 4.
"The expiration date is the recommended shelf life date of the product as provided by the vendor/manufacturer of the bulk product. This information provided by the manufacturer is entered on the original receiving report for raw materials and must always be listed on the bulk containers as received by the manufacturer. If bulk materials are received by any vendor without the expiration date the bulk material will be refused by the shipping/receiving personnel and returned to the vendor."
Please note that the term "shelf life date includes expiration dating and "best if used by" dating [See 72 Fed. Reg. 34912, 34856 (Jun. 25, 2007)]. Any expiration, shelf life, or "best if used by" date you place on a product label should be supported by stability data [See 72 Fed. Reg. 34752, 34856 (Jun. 25, 2007)].
As you know, we receive our blended powders from contract manufacturers. The expiration dating has been determined by our contract manufacturers. We have requested the supporting stability data from our contract manufacturers for all of our new product formulations. In the event that our contract manufacturers are unable to provide us with stability testing data, we will have stability analysis performed.
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Novack and Macey LLP has a national reputation as appellate attorneys, representing both clients for whom we were trial counsel and clients represented at trial by other firms who want first-class representation on appeal.
Since 2010, the firm as a whole has won more than 90% of its appeals. In the past three years, Steve Novack has achieved seven consecutive victories before the Seventh Circuit Court of Appeals and has 12 straight complete victories and one partial victory in cases before the Illinois Supreme and Appellate Courts.
Our appellate practice, like our trial work, maintains a focus on efficient staffing and alternative billing to ensure our appellate clients that we are delivering value.
Bankers Life & Casualty Insurance Co. v. CBRE, Inc., No. 15-1471 (7th Cir. 2016): The court adopted Novack and Macey’s attorneys’ argument that the district court erred in confirming an arbitration award that was based on the arbitrators modifying the terms of the parties’ agreement and otherwise committing gross errors on the face of the award. Stephen Novack, Andrew D. Campbell, Shelby L. Drury and Andrew P. Shelby.
RFO Holdings, Inc., et al. v. Metropolitan Capital Bank, et al., 2015 IL App (2d) 140320-U (Ill. App. Ct. 2015): Obtained reversal of a temporary restraining order entered against our client by circuit court. P. Andrew Fleming, Timothy J. Miller, Elizabeth C. Wolicki.
Bass, et al. v. Streicher, et al., 2015 IL App (1st) 143071-U (Ill. App. Ct. 2015): Obtained the affirmance of the dismissal of the substantive claim. Stephen Novack, Richard G. Douglass.
Life Plans, Inc. v. Security Life of Denver Insurance Co., 800 F.3d 343 (7th Cir. 2015): The court ruled in our client’s favor, reversing the district court’s grant of summary judgment. Stephen Novack, P. Andrew Fleming, Andrew D. Campbell, Richard G. Douglass.
Goldberg v. 401 N. Wabash Venture and Trump Chicago, 755 F.3d 456 (7th Cir. 2014): Judgment in favor of our client affirmed. Stephen Novack, Rebekah H. Parker.
Bunni v. Boykin and Barnes & Thornburg, 2014 IL App (1st) 133137 (Ill. App. Ct. 2014): Summary judgment for our client affirmed. Stephen Novack, Timothy J. Miller.
Mitchell v. JCG Industries and Koch Foods, 745 F.3d 837 (7th Cir. 2014): Affirmed. Stephen Novack, Courtney D. Tedrowe, Andrew P. Shelby, Shelby L. Drury.
Burke v. 401 North Wabash Venture LLC, 714 F.3d 501 (7th Cir. 2013): Victory when the Court affirmed the dismissal of claims. Stephen Novack, Shelby L. Drury.
Safeco Ins. Co. of America & Liberty Mutual Ins. Co. v. American Int’l Group, 710 F.3d 754 (7th Cir. 2013): Objectors appealed a class settlement. Appeal was settled and dismissed. Stephen Novack, Andrew D. Campbell, Rebekah H. Parker.
Howerton v. Prudential Insurance Co., et al., 2012 IL App (1st) 110154 (Ill. App. Ct. 2012): Preserved the dismissal of a class-action complaint against an insurance company. Stephen Novack, Donald A. Tarkington, Andrew P. Shelby.
Kathleen Lawlor v. North American Corporation of Illinois, 2012 IL 112530 (Ill. Sup. Ct. 2012): Dramatically reduced the punitive damages award against client from $1.75 million to $65,000. Eric N. Macey, Julie Johnston-Ahlen.
Selch v. Columbia Management, et al., 2012 IL App (1st) 111434 (Ill. App. Ct. 2012): Appellate Court affirmed grant of summary judgment in our clients’ favor. Stephen Novack, P. Andrew Fleming, Andrew D. Campbell, Christopher S. Moore.
Bond Kildeer Marketplace v. CBS Outdoor, 2012 IL App (2d) 111292 (Ill. App. Ct. 2012): Affirmed the trial court judgment and adopted our argument that client had the right to terminate lease because of unlawful billboard. Stephen J. Siegel.
Gerard M. Kenny, as Trustee of the Trust of Gerard M. Kenny, and Bank of America, N.A., v. Kenny Industries, Inc., 2012 IL App (1st) 111782 (Ill. App. Ct. 2012): Affirmed the denial of a right of setoff against a judgment in favor of our client. Eric N. Macey, Courtney D. Tedrowe, John Haarlow, Jr.
Access Mediquip v. United Healthcare Insurance, 698 F.3d 226 (5th Cir. 2012): Upheld a decision favoring our client on ERISA issue. Stephen Novack, Stephen J. Siegel, Christopher S. Moore.
Dillon v. DTG Operations, Inc., d/b/a Thrifty Car Rental, 2012 IL App (1st) 102441-U (Ill. App. Ct. 2012): Affirmed the dismissal of a putative class action. Stephen Novack, Stephen J. Siegel.
Begg v. Kaplan & Van Ohlen, 2012 IL App (1st) 102382-U (Ill. App. Ct. 2012): Affirmed decision against terminated partner. Stephen Novack, Monte L. Mann, Alexander L. Berg.
Scanlan v. Eisenberg, et al., 669 F.3d 838 (7th Cir. 2012): Reversed trial court’s dismissal of plaintiff’s claims. Stephen Novack, Donald A. Tarkington, Joshua E. Liebman.
Karimi v. 401 North Wabash Venture LLC, 2011 IL App (1st) 102670 (Ill. App. Ct. 2011): This was a victory for Novack and Macey as the Court affirmed the dismissal of claims. Stephen Novack.
Indeck Power Equipment Company v. Professional Power Products, Inc., 2 N.E.3d 661 (2011) (Ill. App. Ct. 2011): The Court affirmed the entry of judgment at the close of the plaintiff’s case. Eric N. Macey.
Millennium Park Joint Venture LLC v. Houlihan, 241 Ill.2d 281 (Ill. Sup. Ct. 2010): The Court affirmed summary judgment in our favor. Stephen Novack, Christopher S. Moore.
Gerard M. Kenny, as Trustee of the Trust of Gerard M. Kenny v. Kenny Industries, Inc., 406 Ill.App.3d 56 (Ill. App. Ct. 2010): The Court affirmed the confirmation of an arbitration award. Eric N. Macey, Courtney D. Tedrowe, John Haarlow, Jr.
Fitch v. McDermott, Will and Emery, LLP, 401 Ill.App.3d 1006(Ill. App. Ct. 2010): The Court affirmed the dismissal in favor of our client. Stephen Novack, Mitchell L. Marinello.
Airport & Weber, LLC v. County of Will, et al., 399 Ill. App.3d 1239 (Ill. App. Ct. 2010): The Appellate Court reversed the trial court’s dismissal of our client’s claims. Stephen Novack, Donald A. Tarkington, Joshua E. Liebman.
Robert Fait, as Trustee of the Robert L. and Judith R. Trust v. Albert Hummel, 333 F.3d 854 (7th Cir. Ct. 2003): Affirmed the trial court’s judgment after a bench trial in our clients’ (defendants') favor in a case for breach of fiduciary duty regarding issuance of corporate stock. Eric N. Macey, Shelby L. Drury.
Illinois State Toll Highway Authority v. Mobil Oil Company, 336 Ill.App.3d 300 (Ill. App. Ct. 2003): Reversed the trial court’s dismissal of a case against our client on motion. Eric N. Macey.
People of the State of Illinois v. Time Consumer Marketing, Inc, 336 Ill.App.3d 74 (Ill. App. Ct. 2002): Affirmed the trial court’s dismissal of a claim against our client under the Illinois Consumer Fraud and Deceptive Business Practices Act. Eric N. Macey, Timothy J. Miller.
Lee N. Mortenson v. National Union Fire Insurance Company of Pittsburgh, PA, 249 F.3d 667 (7th Cir. 2001): Affirmed the trial court’s entry of summary judgment against plaintiffs’ (our client) claim against a former employer’s D&O policy. Eric N. Macey, Timothy J. Miller, Michael A. Weinberg.
For more information about Novack and Macey LLP and its appellate practice, please contact Steve Novack or Chris Moore. Other members of the Appellate Practice Group are Shelby L. Drury, and John Haarlow, Jr.
For more information about Novack and Macey LLP and its experience in appeals, contact our practice area chair, Christopher S. Moore.

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S. Basagni, F. Ceccarelli, C. Petrioli, N. Raman and A. V. Sheshashayee. "Wake-up Radio Ranges: A Performance Study". (To appear in) Proceedings of IEEE WCNC 2019. April. 2019.
S. Basagni, V. Di Valerio, P. Gjanci and C. Petrioli. "MARLIN-Q: Multi-Modal Communications for Reliable and Low-latency Underwater Data Delivery". Elsevier Ad Hoc Networks. January. 2019. pp. 134-145.
S. Basagni, V. Di Valerio, P. Gjanci and C. Petrioli. "Harnessing HyDRO: Harvesting-aware Data Routing for Underwater Wireless Sensor Networks". Proceedings of ACM MobiHoc 2018. Los Angeles, USA. June. 2018.
A. Ridolfi, D. Spaccini, F. Fanelli, M. Franchi, N. Monni, L. Picari, C. Petrioli and B. Allotta. "An autonomous underwater vehicle and SUNSET to bridge underwater networks composed of multi-vendor modems", Annual Reviews in Control. 2018.
G. Kazdaridis, S. Keranidis, P. Symeonidis, P. Sousa Dias, P. Gonçalves, B. Loureiro, P. Gjanci and C. Petrioli. "EVERUN - Enabling Power Consumption Monitoring in Underwater Networking Platforms", ACM WiNTECH 2017. 2017.
P. Gjanci, C. Petrioli, S. Basagni, C. A Phillips, L. Bölöni and D. Turgut. "Path Finding for Maximum Value of Information in Multi-modal Underwater Wireless Sensor Networks", IEEE Transactions on Mobile Computing, Vol. PP. 2017, pp. 1-1.
D. Benedetti, G. Maselli and C. Petrioli. "PrIME: Priority-based Tag Identification in Mobile RFID Systems Computer Communications", Elsevier Computer Communications. 2017.
R. Petroccia, C. Petrioli and J. Potter. "Performance evaluation of underwater MAC protocols: At-sea experiments", IEEE Journal of Oceanic Engineering. 2017.
A. Casavola, G. Cario, P. Gjanci, M. Lupia, C. Petrioli and D. Spaccini. "Long Lasting Underwater Wireless Sensors Network for Water Quality Monitoring in Fish Farms". Proceedings of MTS/IEEE OCEANS 2017. Aberdeen, Scotland, UK. June, 19--22. 2017. pp. 1-7.
A. Ridolfi, B. Allotta, F. Fanelli, N. Monni, C. Petrioli, L. Picari and D. Spaccini. "Enabling Cooperation and Networking in Heterogeneous Underwater Networks composed of Multi-Vendor Vehicles and Modems". Proceedings of MTS/IEEE OCEANS 2017. Aberdeen, Scotland, UK. June, 19--22. 2017. pp. 1-6.
N. Tsiogkas, G. Frost, D. Lane, D. Spaccini, C. Petrioli, T. Salumae, V. Preston and M. Kruusmaa. "MANgO: federated world Model using an underwater Acoustic NetwOrk". Proceedings of MTS/IEEE OCEANS 2017. Aberdeen, Scotland, UK. June, 19--22. 2017. pp. 1-6.
S. Basagni, F. Ceccarelli, F. Gattuso and C. Petrioli. "Demo Abstract: Abating LPL-induced Latency with Wake-up Radio Technology". Proceedings of ACM/IEEE IoTDI 2017. Pittsburgh, PA, USA. April, 18--21. 2017. pp. 299-300.
J. Braga, R. Martins, C. Petrioli, R. Petroccia and L. Picari. "Cooperation and Networking in an Underwater Network composed by Heterogeneous Assets". Proceedings of MTS/IEEE OCEANS 2016. Monterey, CA, USA. September, 19--23. 2016. pp. 1-9.
A. Caiti, P. Gjanci, S. Grechi, R. Nuti, C. Petrioli, L. Picari and D. Spaccini. "OptoCOMM and SUNSET to enable large data offloading in Underwater Wireless Sensor Networks". Proceedings of MTS/IEEE OCEANS 2016. Monterey, CA, USA. September, 19--23. 2016. pp. 1-5.
V. Djapic, W. Dong, D. Spaccini, G. Cario, A. Casavola, P. Gjanci, M. Lupia and C. Petrioli. "Cooperation of coordinated teams of Autonomous Underwater Vehicles". Proceedings of the 9th IFAC Symposium on Intelligent Autonomous Vehicles 2016. Messe Leipzig, Germany. June 29--July 1. 2016. pp. 1-6.
V. Di Valerio, F. Lo Presti, C. Petrioli, L. Picari and D. Spaccini. "A Self-Adaptive Protocol Stack for Underwater Wireless Sensor Networks". Proceedings of MTS/IEEE OCEANS 2016. Shanghai, China. April, 10--13. 2016. pp. 1-8.
G. Cario, A. Casavola, V. Djapic, P. Gjanci, M. Lupia, C. Petrioli and D. Spaccini. "Clock Synchronization and Ranging Estimation for Control and Cooperation of Multiple UUVs". Proceedings of MTS/IEEE OCEANS 2016. Shanghai, China. April, 10--13. 2016. pp. 1-9.
M. Bonuccelli, D. Ermini, L. Pescosolido and C. Petrioli. "Goodput Maximization in Opportunistic Spectrum Access Networks under Constraints on the Inter-Packet Transmission Waiting Time", Elsevier Ad Hoc Networks. 2015.
C. Petrioli, R. Petroccia, J. R. Potter and D. Spaccini. "The SUNSET framework for simulation, emulation and at-sea testing of underwater wireless sensor networks", Ad Hoc Networks, Vol. 34. 2015, pp. 224-238.
S. Basagni, C. Petrioli, R. Petroccia and D. Spaccini. "CARP: A Channel-aware Routing Protocol for Underwater Acoustic Wireless Networks", Ad Hoc Networks, Vol. 34. 2015, pp. 92-104.
V. Di Valerio, C. Petrioli, L. Pescosolido and M. V. Der Shaar. "A Reinforcement Learning-based Data-Link Protocol for Underwater Acoustic Communications". Proceedings of ACM WUWNet 2015. Washington DC, USA. October. 2015.
V. Djapic et al.. "Advanced Underwater Acoustic Networking and Cooperation of Multiple Marine Robots". Proceedings of MTS/IEEE OCEANS 2015. Genova, Italy. May, 18--21. 2015. pp. 1-9.
R. Petroccia, G. Cario, M. Lupia, V. Djapic and C. Petrioli. "First in-field Experiments with a "Bilingual" Underwater Acoustic Modem supporting the JANUS Standard". Proceedings of MTS/IEEE OCEANS 2015. Genova, Italy. May, 18--21. 2015.
S. Sciancalepore, A. Capossele, G. Piro, G. Boggia and G. Bianchi. "On the Design of Lightweight Link-layer Security Mechanisms in IoT Systems". Proceedings of 12th Italian Networking Workshop. Cavalese, Italy. January 14-16. 2015.
G. Koutsandria, R. Gentz, M. Jamei, A. Scaglione, S. Peisert and C. McParland. "A Real-Time Testbed Environment for Cyber-Physical Security on the Power Grid". Proceedings of the First ACM Workshop on Cyber-Physical Systems-Security and/or PrivaCy. New York, NY, USA : ACM. 2015. pp. 67-78.
J. Alves, R. Petroccia and J. Robert Potter. "MPR: Multi-Point Relay protocol for Underwater Acoustic Networks". Proceedings of the Nineth ACM International Conference on Underwater Networks and Systems. Rome, Italy. November 12--14. 2014.
L. Pescosolido, C. Petrioli, L. Picari and J. Alves. "Spectral Density Estimation of Ship-generated Underwater Acoustic Noise". Proceedings of the 9th ACM International Conference on Underwater Networks & Systems. Rome, Italy. Nov. 2014.
G. Koutsandria, V. Muthukumar, M. Parvania, S. Peisert, C. McParland and A. Scaglione. "A Hybrid Network IDS for Protective Digital Relays in the Power Transmission Grid". Proceedings of IEEE SmartGridComm 2014. Venice, Italy. Nov. 2014.
S. Basagni, C. Petrioli, R. Petroccia and D. Spaccini. "Channel Replay-based Performance Evaluation of Protocols for Underwater Routing". Proceedings of MTS/IEEE OCEANS 2014. St. John's, Canada. September, 14--19. 2014. pp. 1-7.
A. Shashaj, R. Petroccia and C. Petrioli. "Energy efficient interference-aware routing and scheduling in Underwater Sensor Networks". Proceedings of MTS/IEEE OCEANS 2014. St. John's, Canada. September, 14--19. 2014. pp. 1-8.
C. Petrioli, R. Petroccia, D. Spaccini, A. Vitaletti, T. Arzilli, D. Lamanna, A. Galizia and E. Renzi. "The SUNRISE GATE: Accessing the SUNRISE federation of facilities to test solutions for the Internet of Underwater Things". Proceedings of UCOMMS 2014. Sestri Levante, Italy. September, 3--5. 2014.
R. Martins, J. B. de Sousa, R. Caldas, C. Petrioli and J. Potter. "SUNRISE Project: Porto University Testbed". Proceedings of UCOMMS 2014. Sestri Levante, Italy. September, 3--5. 2014.
K. G. Kebkal, V. K. Kebkal, O. G. Kebkal and R. Petroccia. "Clock Synchronization in Underwater Acoustic Networks During Payload Data Exchange". Proceedings of the 2nd International Conference and Exhibition on Underwater Acoustics. Rhodes, Greece. June 22--27. 2014.
M. Parvania, G. Koutsandria, V. Muthukumary, S. Peisert, C. McParland and A. Scaglione. "Hybrid Control Network Intrusion Detection Systems for Automated Power Distribution Systems". Proceedings of IEEE/IFIP DSN 2014. June. 2014. pp. 774-779.
M. Conti, G. Turi and G. Maselli. "A Cross-Layer Architecture for Ad Hoc Networks". Springer-Verlag. 2013.
L. Boloni, D. Turgut, S. Basagni and C. Petrioli. "Scheduling Data Transmissions of Underwater Sensor Nodes for Maximizing Value of Information". Proceedings of IEEE Globecom 2013. Atlanta, USA. December. 2013.
D. Spenza. "Towards Self-Powered Wireless Sensor Networks". University of Rome "La Sapienza". 2013.
U. M. Colesanti, A. Lo Russo, M. Paoli, C. Petrioli and A. Vitaletti. "Poster Abstract: Structural Health Monitoring in an Underground Construction Site: The Roman Experience". Proceedings of the 11th ACM Conference on Embedded Networked Sensor Systems. Rome, Italy. November. 2013.
U. M. Colesanti, A. Lo Russo, M. Paoli, C. Petrioli and A. Vitaletti. "Demo Abstract: Introducing the MagoNode Platform". Proceedings of the 11th ACM Conference on Embedded Networked Sensor Systems. Rome, Italy. November. 2013.
C. Petrioli, R. Petroccia and D. Spaccini. "Poster Abstract: SUNSET: An Innovative Framework for Underwater Simulation, Emulation and Real-Life Testing". Proceedings of the 11th ACM Conference on Embedded Networked Sensor Systems. Rome, Italy. November. 2013.
C. Petrioli, R. Petroccia and D. Spaccini. "Demo Abstract: Adaptive Cross-Layer Routing for Underwater Acoustic Sensor Networks with the SUNSET Framework". Proceedings of the 11th ACM Conference on Embedded Networked Sensor Systems. Rome, Italy. November. 2013.
C. Petrioli, R. Petroccia and D. Spaccini. "DEMO: Time Synchronization and Localization for Underwater Acoustic Sensor Networks with the SUNSET Framework". Proceedings of the ACM Mobicom International Workshop on Wireless Network Testbeds, Experimental evaluation and CHaracterization (WiNTECH 2013). Miami, Fl, USA. November. 2013.
C. Petrioli, R. Petroccia and D. Spaccini. "SUNSET version 2.0: Enhanced Framework for Simulation, Emulation and Real-life Testing of Underwater Wireless Sensor Networks". Proceedings of ACM WUWNet 2013. Kaohsiung, Taiwan. November 11-13. 2013.
L. Pescosolido, C. Petrioli and L. Picari. "A Multi-band Noise-Aware MAC Protocol for Underwater Acoustic Sensor Networks". Proceedings of IEEE WiMob 2013. Lyon, France. October. 2013.
P. Casari, M. Nati, C. Petrioli and M. Zorzi. "A detailed analytical and simulation study of geographic random forwarding", Wireless Communications and Mobile Computing, Vol. 13, July, 2013, pp. 916-934.
R. Petroccia and D. Spaccini. "A Back-Seat Driver to Remotely Control the Experiments in an Underwater Acoustic Sensor Network". Proceedings of MTS/IEEE OCEANS. Bergen, Norway : IEEE Oceanic Engineering Society. June, 10--13. 2013.
R. Petroccia and D. Spaccini. "Comparing SUNSET and DESERT Frameworks for In Field Experiments in an Underwater Acoustic Network". Proceedings of MTS/IEEE OCEANS 2013. Bergen, Norway : IEEE Oceanic Engineering Society. June, 10--13. 2013.
N. A. Cruz, B. M. Ferreira, O. Kebkal, A. C. Matos, C. Petrioli, R. Petroccia and D. Spaccini. "Investigation of Underwater Acoustic Networking Enabling the Cooperative Operation of Multiple Heterogeneous Vehicles", Marine Technology Society Journal, Vol. 47, March/April, 2013, pp. 43-58(16).
M. Laganà, I. Glaropoulos, V. Fodor and C. Petrioli. "Modeling and estimation of partially observed WLAN activity for cognitive WSNs". IEEE Wireless Communications and Networking Conference (WCNC). 2012. pp. 1526-1531.
S. Basagni, C. Petrioli, R. Petroccia and M. Stojanovic. "Optimized Packet Size Selection in Underwater WSN Communications", IEEE Journal of Oceanic Engineering. 2012.
A. Camillò and C. Petrioli. "Hands on IRIS: Lessons learned from implementing a cross layer protocol stack for WSNs". Proceedings of IEEE Globecom 2012. Anaheim, California. December, 3-7. 2012.
S. Graziani, S. Lombardi, O. Kebkal, M. Komar, C. Petrioli, R. Petroccia and D. Spaccini. "DEMO: Real-Time Control of an Underwater Sensor Network using the SUNSET Framework". Demo presented at WUWNet '12. Los Angeles, California, USA. November 5--6. 2012.
P. Casari, D. Spaccini, G. Toso, B. Tomasi, R. Petroccia, C. Petrioli and M. Zorzi. "A Study on Channel Dynamics Representation and its Effects on the Performance of Routing in Underwater Networks". Conference Record of ASILOMAR 2012. Pacific Grove, California, USA. November, 4--7. 2012. pp. 1536-1540.
N. A. Cruz, B. M. Ferreira, A. C. Matos, C. Petrioli, R. Petroccia and D. Spaccini. "Implementation of an Underwater Acoustic Network using Multiple Heterogeneous Vehicles". Proceedings of MTS/IEEE OCEANS 2012. Hampton Roads, Virginia. October, 14--19. 2012.
D. Benedetti, G. Maselli and C. Petrioli. "Fast Identification of Mobile RFID Tags". Proceedings of IEEE MASS 2012. Las Vegas, Nevada, USA. October, 8-11. 2012.
M. A. Bonuccelli, D. Ermini, L. Pescosolido and C. Petrioli. "Goodput Maximization in Opportunistic Spectrum Access Radio Links with Imperfect Spectrum Sensing and FEC-based Packet Protection". Proceedings of IEEE MASS 2012. Las Vegas, NV, USA. Oct 8-11. 2012. pp. 344-352.
F. Lo Presti, C. Petrioli, R. Petroccia and A. Shashaj. "A scalable analytical framework for deriving optimum scheduling and routing in underwater sensor networks". Proceedings of IEEE MASS 2012. Las Vegas, Nevada, USA. October 8--11. 2012.
C. Petrioli and R. Petroccia. "SUNSET: Simulation, Emulation and Real-life Testing of Underwater Wireless Sensor Networks". Proceedings of IEEE UComms 2012. Sestri Levante, Italy. September, 12--14. 2012.
C. Stamos, D. Vasileiadou, G. Koutsandria, I. Spanou, A. Vlachaki, A. Lazaris and P. Koutsakis. "User satisfaction-based resource allocation for GEO satellites". Proceedings of IEEE WoWMoM 2012. June. 2012. pp. 1-3.
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The ruling comes down in McGill v. Citibank, N.A.
On April 6, 2017, in McGill v. Citibank, N.A., the California Supreme Court held that that predispute arbitration provisions aimed at public injunctive relief that result in barring certain statutory claims for such relief are unenforceable. McGill applies to claims for public injunctive relief sought under California’s Consumer Legal Remedies Act, Cal. Civ. Code § 1750, et seq.; the unfair competition law, Cal. Bus. & Prof. Code § 17500, et seq.; and the false advertising law, Cal. Bus. & Prof. Code § 17500, et seq.
McGill lost her job in 2008, and Citibank allegedly failed to honor the terms of the credit protection agreement. She filed suit in 2011, and pursuant to the arbitration clause, Citibank moved to compel arbitration. Applying the Broughton-Cruz rule (which renders arbitration clauses requiring arbitration injunctive relief claims brought for the public’s benefit unenforceable), the trial court ordered arbitration of McGill’s claims other than those seeking injunctive relief under the CLRA, the UCL, and false advertising law. The Court of Appeal reversed and remanded “for the trial court to order all of McGill’s claims to arbitration” under AT&T Mobility LLC v. Concepcion, 563 U.S. 333 (2011). The California Supreme Court granted McGill’s petition for review of this decision.
Consequently, claims for public injunctive relief—injunctive relief with a primary effect of prohibiting acts that threaten the general public—brought under California's CLRA, UCL, or false advertising law are unlikely to be compelled to arbitration, particularly if doing so would preclude any relief on those claims.