FDA unveils new regulations on e-cigarettes
(from Associated Press at CBS News) — Hundreds of electronic cigarette brands will have to undergo federal review to stay on the market under new rules that have the potential to upend a multi-billion dollar industry attempting to position itself as an alternative to traditional cigarettes.
The Food and Drug Administration (FDA) on Thursday released long-awaited rules that bring the burgeoning industry under federal oversight.
The changes will ban e-cigarette sales to people under 18 and require new health warnings. In a shift vigorously opposed by the industry, manufacturers must seek federal permission to continue marketing all e-cigarettes launched since 2007, making up the vast majority of the market. [The new rule will require companies to show what is in their products, excluding those that have been on the market since before 2007, since there were few if any e-cigarettes on the market prior to 2007. The new rule will not go into effect immediately, since companies will need time to comply.]
Most companies will have to submit premarket* applications that will undergo review to assess their impact on the “public health.” Those that don’t submit the required information or don’t meet federal standards would have their products removed from the market. [*premarket is a product before it is put in stores; before it is sold]
E-cigarettes are battery-powered devices that turn nicotine into an inhalable liquid vapor. Though nicotine can be addictive, e-cigarettes lack the chemicals and tars of burning tobacco.
Yet the devices haven’t been extensively studied and there’s no scientific consensus on any potential benefits or harms from “vaping,” including whether it leads young people to become regular smokers.
The FDA action comes five years after the agency first announced its intent to regulate e-cigarettes and more than two years after it floated its initial proposal.
Public health advocates applauded the news.
“Ending the tobacco epidemic is more urgent than ever, and can only happen if the FDA acts aggressively and broadly to protect all Americans from all tobacco products,” said Harold Wimmer, president of the American Lung Association. …
The American Academy of Pediatrics praised the rules as “a welcomed starting point,” but said the FDA didn’t go far enough to protect children. “FDA passed up critical opportunities in this rule by failing to prohibit the sale of tobacco products coming in flavors like cotton candy, gummy bear and grape or to prevent marketing tactics that target children,” the doctors’ group said in a statement.
The new requirements are likely to set up a legal showdown with manufacturers, many who have warned that the costs of complying with FDA regulation could wipe out their industry.
The FDA has stumbled before in its efforts to regulate this industry. In 2010, a federal appeals court threw out the agency’s plan to treat e-cigarettes as drug-delivery devices, rather than tobacco products. The ruling was seen as a win for manufacturers who opposed the stringent and expensive requirements of conducting pharmaceutical-style studies.
House Republicans are pushing industry-backed legislation that would prohibit the FDA from requiring retroactive safety reviews of e-cigarettes that are already on the market and exempt some premium and large cigars from those same regulations. E-cigarette products introduced in the future would still undergo the safety reviews. …
The FDA first gained authority to regulate some aspects of cigarettes and other traditional tobacco products under a 2009 law [the Family Smoking Prevention and Tobacco Control Act]. But since e-cigarettes do not actually contain tobacco, they were not covered by the original law.
In April 2014, the FDA first proposed bringing e-cigarettes and other nontraditional tobacco products under its authority, including cigars, hookahs, nicotine gels and pipe tobacco. The agency was expected to finalize that proposal last June, but the deadline slipped for months due to industry resistance.
Some smokers like e-cigarettes because the nicotine-infused vapor looks like smoke but doesn’t contain the tar or odor of regular cigarettes. They are sometimes promoted as a way to help smokers quit or cut down on tobacco. However, there’s not much scientific evidence showing e-cigarettes help smokers quit or smoke less, and it’s unclear how safe they are.
E-cigarettes sales grew to an estimated $3.5 billion in 2015, according to Wells Fargo. After ballooning in over several years, sales have recently begun to slow due to negative publicity and questions about safety. Retail sales are dominated by a handful of traditional tobacco companies, including Reynold’s American’s Vuse and Imperial Tobacco’s blu brands. Those products are sold nationwide at convenience stores and gas stations.
Hundreds of smaller companies sell more specialized products — often with refillable “tanks” and customized flavors — at vape shops and over the Internet. That space alone may be worth $2 billion in sales, according to estimates, though precise figures are not available.
2. What requirements are included in the new rules? Be specific.
3. What isn’t known yet about the benefits or harms from vaping?
4. a) Who supports the new FDA rules on e-cigarettes?
b) Why does the American Academy of Pediatrics
5. Who opposes the news rules? Why?
6. a) Define regulate.
b) Do you think it is necessary for the federal government to regulate e-cigarettes? Why or why not?
c) Ask a parent the same question.
7. With the new regulations, people under the age of 18 won’t be able to buy these products. Currently, not all states forbid sales to minors. What do you think the age requirement should be for purchasing e-cigarettes? Explain your answer.
The FDA held three public workshops to gather information about the devices and the potential impact on public health. The public comment period closed July 2, at which point the agency began a review of approximately 130,000 comments that informed the final rule.
The purpose of those workshops was to figure out what the risks of e-cigarettes are when used properly and how many chemicals and nicotine are inhaled when someone uses them. The FDA also wanted to know about any potential health benefit.
Some studies have showed that using e-cigarettes would be a good way to help a person quit smoking. In 2014, the Royal College of Physicians published a statement that suggested they were an effective and affordable alternative to conventional cigarettes and could “make harm reduction a reality for smokers.”
E-cigarette use among adults has gone up about 12.6%, according to Centers for Disease Control and Prevention (PDF) data from 2014. Among the adults who tried to quit smoking that year, more than a half had tried e-cigarettes as an alternative, and more than 20% started using them. Only a little more than 3% of people who had never smoked tried them, but what has troubled public health leaders is the news that people between ages 18 and 24 had the highest number of new users.
With the new regulations, people under the age of 18 won’t be able to buy these products. Currently, not all states forbid sales to minors.
Research has showed that e-cigarettes have become a problem for children. This year, the CDC found that e-cigarette use had tripled among teens in just one year, and recent research found that teens who used them were more than three times as likely to smoke traditional cigarettes a year later.
That FDA made its first big move to regulate e-cigarettes in 2009, when an FDA test on a small number of e-cigarette samples found “detectable levels of known carcinogens and toxic chemicals to which users could potentially be exposed.” Diethylene glycol was found in one cartridge at a 1% level; an ingredient used in antifreeze, it can be toxic to humans in large quantities. Diethylene glycol is also found in some dental products and in some pharmaceuticals.
After that study, the FDA banned the sale of e-cigarettes. It warned e-cigarette users that they were inhaling “toxic” and “harmful” chemicals. However, in 2010, a court ruled that “the FDA had cited no evidence to show that electronic cigarettes harmed anyone” and that stores could continue selling them.
The new rules will also require companies to register with the FDA and put health warnings on their packages and in their ads. It gives the agency the authority to evaluate the potential health impact of these ingredients on users.
Ray Story, the founder and CEO of the Tobacco Vapor Electronic Cigarette Association, called the ruling “a complete disaster.” Since 2009, his association has advocated for a change in the law that would require age verification and restrict sales to minors.
“No children should have access to these products. Just like with alcohol, these are adult products,” he said.
What he takes issue with is the FDA requirement for approval on the products, down to the batteries. He said the rule “essentially bans the product across the land.”
He believes that all the former cigarette smokers who switched to e-cigarettes will now have to go back. “This is a big blow to public health,” he said. “When you see everyone switching back to conventional tobacco, the pharmaceutical industry will be happy, since they will now have an endless supply of new customers.”
Companies will probably file lawsuits that could delay implementation of parts of the law for decades. Story said he will be meeting with his group’s lawyers today to discuss options.
The FDA said it has been preparing to enforce the law with state- and local-level experts and will add inspectors to be sure retail stores are not selling to minors.
The FDA also enforces other laws, notably Section 361 of the Public Health Service Act and associated regulations, many of which are not directly related to food or drugs. These include sanitation requirements on interstate travel and control of disease on products ranging from certain household pets [etc.].
The FDA is led by the Commissioner of Food and Drugs, appointed by the President with the advice and consent of the Senate. The Commissioner reports to the Secretary of Health and Human Services. The current Commissioner is Dr. Robert Califf. He was confirmed as Commissioner in February (2016).
The FDA has its headquarters in Maryland, and also has 223 field offices and 13 laboratories located throughout the 50 states, the United States Virgin Islands, and Puerto Rico. In 2008, the FDA started opening offices in foreign countries, including China, India, Costa Rica, Chile, Belgium, and the United Kingdom.
The FDA’s federal budget request for fiscal year (FY) 2012 totaled $4.36 billion, while the proposed 2014 budget was $4.7 billion.
About $2 billion of this budget is generated by user fees. Pharmaceutical firms pay the majority of these fees, which are used to expedite drug reviews.
Most federal laws concerning the FDA are part of the Food, Drug and Cosmetic Act, (first passed in 1938 and extensively amended since)
Since the Family Smoking Prevention and Tobacco Control Act became law in 2009, the FDA also has had the authority to regulate tobacco products. (from wikipedia)