FDA Regulation of Tobacco: What Does it Mean?
Public health advocates have been fighting for FDA regulation of tobacco for over 15 years. However, not every public health advocate has supported this particular piece of legislation, and the fact that Philip Morris Tobacco Company supported it caused many to have doubts. But now that the bill is finally going to be law, what will it mean? As a guide to this, I’d recommend that you read the slides from a paper by Mitch Zeller at the recent Virginia Youth Tobacco Conference. Much of this post is adapted from his slides. These outline the key parts of the bill and what they mean in some detail and are worth a careful read, (Mitch Zeller is the former Associate Commissioner and Director of the Office of Tobacco Programs at the Food and Drug Administration). Download his slides from:
The bill does not require FDA to regulate tobacco exactly the same way it does pharmaceuticals (drugs and devices), partly because it would be impossible for any tobacco product to demonstrate that it is safe and effective for its purpose. So instead the legislation creates a new, parallel set of rules and procedures just for tobacco, but using much of the same regulatory framework that was created for drugs. The new standard around which the tobacco bill is based is THE PROTECTION OF PUBLIC HEALTH.
-Section 904 mandates that FDA will receive brand-specific information on ingredients, nicotine delivery, and any smoke constituent FDA identifies as harmful or potentially harmful
- Companies must also provide FDA with all documents developed after the bill is enacted related to health, toxicological, behavioral, or physiologic effects of current or future products.
- FDA also has the right to request any such industry document produced prior to the enactment of this law.
- FDA can issue performance standards to prohibit or limit the allowable levels of substances in a finished tobacco product. FDA is granted this power in section 907. Products that don’t comply with the levels established in product standards can’t be sold.
- Nicotine cannot be banned but it can be reduced to very low levels.
- FDA needs to have supporting science to back up any standards it requires, or any ingredients it wants banned.
Clearly the tobacco product standards are going to be a key part of regulation of tobacco. Here’s what the bill says on these:
TOBACCO PRODUCT STANDARDS.—The Secretary may adopt tobacco product standards…if the Secretary finds that a tobacco product standard is appropriate for the protection of the public health. This finding shall be determined with respect to the risks and benefits to the population as a whole, including users and non-users of the tobacco product, and taking into account—
(A) the increased or decreased likelihood that existing users of tobacco products will stop using such products; and
(B) the increased or decreased likelihood that those who do not use tobacco products will start using such products.
Note that a component of a tobacco product may be banned if it is decided that it “may be harmful”. Thus absolute certainty and proof is not the standard required.
However, there are also provisions that appear to be designed to protect the industry from inappropriate standards, and some have argued that these open up a Pandora’s Box of potential legal appeals over key issues. For example, the required change to a tobacco product must be technically achievable, and must not create an increased demand for contraband or counterfeit products that do not meet the required standard. So for example if it was decided that no cigarette could contain more than 0.1mg of nicotine, the industry lawyers may appeal on numerous grounds, including that it is not technically feasible and it would create a demand for black market normal nicotine cigarettes.
•Any product (even if only test-marketed) or product modification that was introduced after February 15, 2007 is considered a new product that must be evaluated by FDA.
•A provision in section 910 allows a product introduced up to 21 months after the bill is signed into law to remain on the market unless FDA makes a determination that such a product is not substantially equivalent to a product marketed prior to February 15, 2007. (This is to allow FDA sufficient time to set up procedures and gather expertise in order to evaluate products).
- So in less than 2 years time FDA will need to be ready to make relatively fast decisions (<90 days) on all new products. (I suspect we are going to see an increase in new product launches over the next 2 years for that reason).
- ·The bill bans the use of terms like “light,” “low tar,” “mild,” and similar terms.
·Section 911 of the bill requires any express or implied harm reduction claim, including an exposure reduction claim, to be evaluated by FDA prior to marketing.
·Approval for such a claim is subject to a very high standard of scientific substantiation. Industry opponents of the bill, and public health advocates of expanded use of smokeless tobacco, have complained that the standard in this section is too high.
•Under the bill, a claim can only be approved if a company can demonstrate that the product, as actually used by consumers, will “significantly reduce harm” to individuals, and benefit the health of the population as a whole taking into account both users and non-users of tobacco products.
•FDA must take into account the unintended population level effects from proposed claims, such as:
–Decreased interest in quitting
–Increased interest in initiating use of the product among ex-smokers and those who never used tobacco products
–The risks and benefits to users of the product compared to the use of NRT and other products designed to treat tobacco dependence
Other parts of the bill state that:
• Cigarette packages will have warning labels that cover 50 percent of the front and rear. The word "warning" must be included in capital letters.
• Any remaining tobacco-related sponsorships of sports and entertainment events will be banned, as will giveaways of non-tobacco items with the purchase of a tobacco product. A federal ban will be imposed on all outdoor tobacco advertising within 1,000 feet of schools and playgrounds.
• Point-of-sale advertising will be limited to adults-only facilities, and remaining vending machines will disappear except in places restricted to adults. Retailers who sell to minors will be subject to federal enforcement and penalties.
• Tobacco sweetened by candy flavors or any herb or spices such as strawberry, grape, orange, clove, cinnamon or vanilla will be banned.
·The entire FDA regulatory program is to be funded by tobacco industry user fees…really more of a market share allocation by company.
·The program budget grows from $85 million in Year 1, to $235 million in Year 2, to $450 million in Year 3, and ultimately to $712 million in Year 11 and subsequent years.
So although it has taken a tremendous amount of work for over a decade to get this bill passed, in reality the heavy work is just about to start. The tobacco industry and their lawyers have been anticipating this for a long time and will already have a game plan ready to roll out. From the moment the bill is signed the clock is ticking. FDA will need to appoint someone to be in charge of this new part of the agency, and start putting together teams with experience in regulating, and experience in nicotine and tobacco. This will include scientists, regulators and I suspect many lawyers. How this is implemented will depend very much on the individuals who are appointed to key positions.
85 million new dollars in one year may sound like a lot of money, but it will be a challenge for a new government bureaucracy to spend that money efficiently and effectively in a short space of time from a standing start. Even such mundane things as finding new office space can be a challenge. New space will be required to house the new tobacco team, but they will likely need to be close enough to existing FDA offices to stay linked and make use of existing FDA expertise.
As I have stated in previous posts, I believe the bill’s advantages greatly outweigh its disadvantages. However, the key here is how it is implemented. Only time will tell. It is going to be a very interesting next few years for tobacco control in the United States.