DUBLIN, Ohio, Nov. 1, 2018 /PRNewswire/ — On Halloween the FDA issued a statement describing their ongoing conversations with the tobacco industry occurring as a result of the recent epidemic in youth use of electronic cigarettes. Commissioner Scott Gottlieb reported that some tobacco manufacturers support “raising the minimum age to purchase tobacco to 21 years of age.”
We cannot be fooled by their words: the industry supports criminal sanctions on youth who fall prey to their predatory marketing tactics and addictive products, attached to legal provisions that shield retailers who profit from the sales of these deadly products. The Preventing Tobacco Addiction Foundation and Tobacco 21 advocate for raising the minimum legal sales age of all nicotine and tobacco products to 21, coupled with reliable and robust enforcement that holds the industry and retailers responsible.
The tobacco industry’s statements to the FDA of their support for a policy that raises the access for tobacco products is a cynical distraction. The industry knows the FDA does not have the regulatory authority to raise the age to 21, but the FDA can and must respond to this epidemic through policy action within its regulatory authority. This includes a ban on candy flavors, tight restriction of high dose nicotine salts and limits to where these products may be sold.
History has made clear that voluntary action by tobacco manufacturers always fails. The tobacco industry’s claims of cooperation can never be a substitute for effective regulation to protect public health and keep kids from lifelong nicotine addiction.
We call on the FDA to immediately implement the following:
A Complete Assessment of the Teen Nicotine Addiction Epidemic
- The FDA and CDC must expedite the release of the 2018 Youth Tobacco Survey, completed 5 months ago, that demonstrates an epidemic surge in teen addiction.
- The FDA and CDC must require robust, standardized annual surveys of youth and adult nicotine and tobacco use in all states and major metropolitan areas precedent to the release of federal monies for prevention. These studies must address perception and use of individual brands.
Require Investigational New Drug Applications and Restrict Nicotine Salts
- Juul and other manufacturers have produced novel and patented drug formulations including nicotine benzoate and other nicotine salts in unique carrier solutions that deliver high dosages of addictive nicotine to the pulmonary and central nervous system of teen users. These salts reduce the usual irritant sensation of nicotine to the mouth and throat, thus promoting increased depth of inhalation and frequency.
- The FDA must insist on required investigational new drug applications (IND) to be submitted to the Center for Drug Evaluation and Research (CDER).
- Because these drugs are already in widespread use and their abrupt elimination might cause distress in adult users, an interim solution in advance of required CDER evaluation would be to remove them to “behind the counter,” sign-out security in pharmacies, similar to the treatment of pseudoephedrine. Clearly, nicotine salts are of equal or greater risk to public health. Suggestions by the FDA to restrict these product sales to newly-hatched and unregulated “vapor shops” as a means of public health protection is an egregious error that flies in the face of common sense.
Ban Characterizing Flavors
- There is overwhelming evidence that adolescents are enticed into usage by candy, mint and other flavors, while there is no evidence that adult users committed to cessation of combustible tobacco require flavors to make that switch. Any small incentive for adult users is overwhelmed by the risk to teens.
- All characterizing flavors should be immediately removed from products offered to the public. This is perhaps the most important step the FDA can take immediately to stem this tsunami of teen nicotine addiction.
Rob Crane, MD
October 31, 2018