FDA Releases Draft Guidance on Pre-Submission Consultation Process for Animal Food Additive Petitions or Generally Recognized as Safe (GRAS) Notices
- On February 13, 2020, the Food and Drug Administration (FDA) announced the availability of Draft Guidance for Industry #262, “Pre-Submission Consultation Process for Animal Food Additive Petitions or Generally Recognized as Safe (GRAS) Notices.” When finalized, the guidance document will help industry submit information for efficient consultations with FDA’s Center for Veterinary Medicine regarding both animal feed petitions and GRAS Notices.
- The draft details what information FDA would expect to review when receiving different requests (e.g., a request to review the adequacy of existing data from a completed study versus a request to review a study protocol). The guidance also includes FDA timeline “goals” for reviewing certain types of submissions. For example, FDA’s goal for commenting on a study protocol without method validation or preliminary data is 50 days from the date of submission receipt, whereas the goal for commenting on a study protocol with method validation or preliminary data is 130 days from the date of submission receipt.
- FDA is accepting comments on the draft guidance through April 13, 2020. Comments may be submitted here.
- In response to stakeholder comments, California’s Office of Environmental Health Hazard Assessment (OEHHA) has proposed amendments to clarify ambiguities in Article 6 of its Proposition 65 (Prop 65) warning regulations. Prop 65 is a right-to-know law that requires individuals to receive a clear and reasonable warning before being exposed to certain chemicals that California deems to be carcinogens or reproductive toxicants. As summarized here, OEHHA’s final rule amending Article 6 of the regulations implementing Prop 65 became effective in 2018 and imposed requirements on content and methods of transmission, including new Prop 65 warning language.
- Among other clarifications, the amendments proposed by OEHHA on January 31, 2020 would make it explicit that:
- Sales through mobile devices are covered by current Article 6 regulations that require warnings for “internet sales;”
- The option of providing warnings via an electronic device or a process that automatically provides the warning to the purchaser prior to or during the purchase of a product is only for a “physical retail location;”
- Product-specific safe harbor warning provisions apply to all products that are subject to specific safe harbor warnings under Prop 65;
- Product-specific warnings must be provided for online or catalog sales of those products;
- Foreign language translations of product-specific warnings will be required; and
- Product-specific warnings (e.g., for food, furniture, etc.) may be provided under the existing regulation on catalog warnings.
There are also several new proposed amendments that apply specifically to alcoholic beverages. Keller and Heckman has prepared a full analysis, available here, of OEHHA’s proposed amendments to its Article 6 regulations on Prop 65 warnings. OEHHA is accepting comments on the proposed amendments through March 16, 2020.
- Keller and Heckman LLP attorneys actively advise clients on compliance issues and enforcement actions related to California’s Prop 65. If you have any questions about the amendments to Article 6 or related matters, or would like assistance preparing comments, please email email@example.com.
- The U.S. Food and Drug Administration recently issued a warning letter to Smart Toothpicks LLC, of Tempe, Arizona, for several violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act. Smart Toothpicks sells nicotine-infused birch toothpick products in different flavors, including “Peppermint Ice,” “Wintergreen,” and “Cinnamon” Nicotine Toothpicks. FDA’s warning letter focused on the following, specific violations: (1) selling a tobacco product to a minor through the company’s website; (2) selling unauthorized modified risk tobacco products; and (3) failing to include required nicotine addiction warning statements on both packaging and advertising. In making the illegal sales finding, FDA cited the fact that a person younger than 18 years of age was able to purchase Peppermint Ice Nicotine Toothpicks from the company’s website. The company’s website also contained some advertising claims that came under scrutiny as modified risk claims because they represented that the product presents a lower risk of tobacco-related disease or is less harmful than other commercially marketed tobacco products (such as its website claims, “Nicotine Satisfaction without smoke damage to your lungs” and “Smart Toothpicks – A catalyst to promote a healthier way of life… in a flavorful way!”). The products were also found to be misbranded because both the website and the product packaging were missing the required nicotine addiction warning statement.
- This action provides an illustration of the Agency’s interpretation of “tobacco product,” which FDA defines broadly as any product made or derived from tobacco that is intended for human consumption. The Agency takes the position that this definition includes novel, non-tobacco products that contain nicotine derived from tobacco, such as nicotine-infused toothpicks. Referring to the nicotine-infused toothpicks as “dissolvable tobacco products,” the Agency concluded that the products are “covered tobacco products” under 21 C.F.R. § 1140.3, and thus subject to the same FDA requirements as other deemed products, including sales restrictions to minors and marketing authorization requirements.
- This action also signifies the extensive reach of FDA’s regulatory authority, and highlights to others in the growing novel nicotine products industry that FDA remains focused on holding retailers and manufacturers accountable for marketing and sales practices that can lead to increased youth appeal of tobacco products. In fact, FDA has gone on record to state that it is increasingly focused on “novel nicotine-containing products” as one such way to facilitate youth access and nicotine addiction. Accordingly, others in the industry would be prudent to heed this warning and ensure full compliance with FDA regulations, including heightened age verification for online sales and reviewing product advertising and any use of non-tobacco flavors appealing to minors.
Be sure to register for Keller and Heckman’s E-Vapor and Tobacco Law Symposium on February 11-12, 2020 in Irvine, California. Details and Registration information can be found here.