E-Cigarette Deeming Rule
On May 5 the FDA finalized its Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act rule, making e-cigarettes and other tobacco products subject to extensive FDA regulation. We expect the final rule to have a substantial impact on small and medium-sized market participants, with the potential overall effect of allocating greater market share to large traditional tobacco companies. In short, the final rule imposes significant costs on the e-cigarette industry, along with premarket authorization requirements for “new” tobacco products that are not substantially equivalent to a valid predicate product, or are not exempt from substantial equivalence (SE). Given the rapidly evolving technology and innovation germane to the ecigarette industry, it is unlikely that a valid predicate product will be available for many of today’s e-cigarette models.
This means that e-cigarettes are now subject to various market entry requirements, including the submission of a Premarket Tobacco Product Application (PMTA). Among other things, a PMTA requires manufacturers to provide detailed information on product ingredients and additives, health risks, product use (including expected use with other products), labeling, and manufacturing. In addition, new nonclinical and clinical studies may also be required for market authorization if few or no scientific studies have been performed assessing the product's potential public health impact. Although larger industry members may be well positioned to expend such resources, these requirements may hinder market entry for smaller businesses, especially given that each PMTA can take 5,000 hours and cost approximately $300,000, based on FDA estimates.
For non-flavored and tobacco-flavored newly deemed products that are on the market as of August 8, 2016, the final rule’s effective date, but were not on the market as of February 15, 2007, FDA is providing the following staggered compliance policy:
- 12-month initial compliance period for manufacturers to submit an SE exemption request
- 18-month initial compliance period for manufacturers to submit SE reports
- 24-month initial compliance period for manufacturers to submit a PMTA
After the end of the compliance period, e-cigarettes may be subject to FDA enforcement action unless the products are grandfathered or the subject of a marketing authorization order. This staggered compliance policy is designed to allow applicants more time to submit robust premarket submissions and allow FDA to efficiently manage incoming applications, all while balancing public health concerns.
FDA Makes Major Changes to Nutrition Facts Label
The FDA recently issued two final regulations that present overhaul changes to the Nutrition Facts and Supplement Facts labels and update serving sizes. The labels are being revised for the first time in decades to reflect updated scientific information regarding public health, diet, and chronic diseases. Serving sizes have been adjusted to be more representative of the amount of food that is actually consumed today.
Some updates consist of formatting changes designed to direct the consumer’s attention to calories and serving sizes. For instance, the word “Calories” is presented in larger typeface than other items on the Nutrition Facts label to highlight the importance of calories as an element consumers consider when making healthier food choices and to address the American obesity epidemic. The listing of mandatory nutrients has also changed.
Vitamin D and potassium are now required to be listed, given that a deficiency of these nutrients has been associated with higher risks for chronic disease. Vitamins A and C, on the other hand, are no longer required on the Nutrition Facts label since deficiencies of these vitamins are now rare. Another major and controversial change to the Nutrition Facts label is the requirement for food companies to now declare “added sugars,” a new category intended to assist consumers in distinguishing between sugars added during processing and those that are naturally present in certain foods (such as fresh fruits). This change is consistent with expert recommendations advising consumers to reduce intake of added sugars based on the belief that they deliver empty calories to the diet without providing additional nutritional benefits.
Other changes to the Nutrition Facts label include the definition for dietary fiber being revised to consist of naturally occurring fibers and fibers added to foods for a physiological health benefit, and updates to serving sizes to be more realistic representations of what consumers actually consume at one time. Further, despite FDA’s final determination on trans fat, it will remain on the Nutrition Facts label because certain foods may contain naturally occurring trans fat. In addition, the explanation of Percent Daily Values at the bottom of the Nutrition Facts label has been simplified; however, it is still based on a 2,000 calorie diet.
The FDA also made some changes to the Supplement Facts label found on dietary supplements to make it consistent with the Nutrition Facts label.
These changes mean additional documentation responsibilities for manufacturers, which now will be required to keep records to verify the mandatory declaration of certain food constituents for which analytical methods are not available, such as added sugars, certain dietary fibers, vitamin E, folic acid, and folate. Industry has two years to comply with these requirements, with the exception of companies with less than $10 million in annual sales, which will have an additional year to comply. The new requirements will affect nearly all conventional foods and may lead to major reformulations of certain products. For instance, the mandatory declaration of added sugars may lead manufacturers to reformulate sodas and processed foods. FDA estimates that while implementing the changes may cost the food and beverage industry approximately $500 million annually, the changes should result in roughly $2 billion annually in reduced health care costs over the next two decades.
FDA Requires Industry to Implement Food Defense Plans
The FDA’s recently issued final rule, Mitigation Strategies to Protect Food Against Intentional Adulteration, requires food companies to implement plans to protect their products from acts of intentional adulteration. The rule requires covered domestic and foreign food facilities to consider their production processes and facilities and develop proactive strategies to ensure product safety and security and mitigate any widespread harm to public health. According to FDA, the requirements are intended to further bolster the safety and security of an increasingly global and complex food supply system.
Under the rule, certain covered facilities must prepare and implement written food defense plans that identify “vulnerabilities,” or areas that may present risk in the manufacturing process. To identify vulnerabilities, food facilities should assess, among other factors, the degree of physical access to the product, the speed by which the product moves through production and the distribution system, the ability of an attacker to successfully contaminate the product, and any potential agents that may be used by attackers. Based on this assessment, food facilities are required to implement mitigation strategies addressing the vulnerabilities and procedures for food defense monitoring. Where issues are identified, facilities must assign appropriate corrective actions and implement procedures to routinely verify that the food defense monitoring system is working. The rule also presents additional training and recordkeeping requirements – facilities must ensure that personnel (particularly those working in vulnerable areas) are properly trained, and companies must maintain records of food defense monitoring, corrective actions, and verification activities. While the requirements incorporate concepts similar to the Hazard Analysis Critical Control Point (HACCP) system (an approach for the identification, evaluation, and control of food safety hazards), a food defense plan is not the same as a food safety plan, given that the former is designed to address intentional contamination, and the latter focuses on unintentional health and safety risks inherently associated with food processing and storage. Accordingly, a food defense plan must take into account other considerations not seen in a typical HACCP system, such as the possibility of an inside attacker or physical barriers to access.
FDA has provided staggered compliance periods based on the size and operations of a covered food facility. Very Small Businesses (businesses averaging less than $10,000,000 in sales per year, as defined under the regulations), while exempt, still have to comply with the modified requirements (i.e., documentation retention requirements supporting exemption) within five years. Small Businesses (those that employ fewer than 500 persons) must comply four years after the publication of the final rule. Covered food facilities that do not meet the foregoing requirements have to comply three years after the publication of the final rule.