- Criticizing the US Department of Agriculture (USDA) and Food and Drug Administration (FDA) for lack of oversight over foods produced with gene editing technology (e.g., Zinc Finger Nucleases, TALENS, or CRISPR/Cas 9), the Center for Science in the Public Interest (CSPI) is calling for a federal registry of all gene-edited agricultural crops.
- CSPI is not requesting a registry of genetically-modified (GM) agricultural crops, which CSPI notes are subject to government oversight under 7 CFR Part 340 of USDA’s regulations and which are evaluated by FDA under its voluntary plant biotechnology consultation program. It is focused on gene-edited crops in particular because they have not historically been subject to 7 CFR Part 340 or any other mandatory federal regulations. According to CSPI, at least 11 developers of gene-edited crops have gone through USDA’s “Am I regulated?” process to inquire into whether they are subject to USDA regulations on GM crops, and all have been informed that they are outside of the scope of those regulations.
- Consistent with a recent FDA reminder encouraging industry to participate in its voluntary consultation program in part to foster public confidence in the safety of biotechnology, CSPI is encouraging the establishment of the registry to “allay consumer concerns about this emerging technology and allow the benefits of this new technology to be realized.”
FDA Issues Initiation of Voluntary Recall Draft Guidance
- Today, FDA published a draft guidance on ways to prepare, plan, and work with the FDA to ensure voluntary recalls are initiated properly and timely. The draft guidance, titled “Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C,” applies to voluntary recalls of all products subject to FDA’s jurisdiction, including food, drug, and devices intended for human or animal use, any cosmetic and biological product intended for human use, any tobacco product intended for human use, and any item subject to a quarantine under 21 CFR Part 1240.
- As mentioned in FDA’s press release, the draft guidance includes recommendations in three key areas:
- Training – The draft guidance emphasizes the importance for firms in a product distribution chain to be “recall ready” to help minimize public exposure to products that are in violation of the Food, Drug, & Cosmetic Act and other laws administered by FDA. The draft guidance advises companies on ways to best identify and train appropriate personnel on their responsibilities during a recall, establish a recall communications plan, and identify what FDA reporting requirements there may be, among other things.
- Recordkeeping – The draft guidance discusses the need for thorough and organized distribution records, that should be maintained over a period of time. Further, the FDA states that products should have specific product coding, whether required by law or not. Product coding assists in facilitating effective recalls and may help a recalling firm accurately define and limit the scope of the recall effort.
- Procedures – The draft guidance recommends that firms consider preparing and maintaining written recall initiation procedures to help minimize delays, ensure that necessary actions are not overlooked, and minimize the disruptive effect a recall can have on a business. FDA notes in the draft guidance that recall initiation procedures do not supersede any other specific recall plan requirements (e.g., HARPC written recall plans).
- FDA believes the draft guidance effectuates an important step towards achieving the Agency’s goal of quickly executing recalls and reaching consumers with timely information to limit the impact of potentially dangerous products. Stakeholders may submit comments on the voluntary recall draft guidance until June 24, 2019. Keller and Heckman attorneys are well-versed in recall procedures and are available to assist interested parties in preparing comments for submission to FDA. For assistance, please email: fooddrug@khlaw.com
Washington State Bill Restricts Marketing of Degradable Food & Other Packaging
- The Washington State legislature has passed a bill that restricts the marketing of degradability products, including food packaging and food service ware. The bill, HB 1569, was passed by the senate on April 15 and signed by the Speaker of the House on April 18.
- HB 1569 specifies that products labeled as compostable must either be comprised only of wood or fiber-based substrate OR must meet the American Society of Testing and Materials (ASTM) composting standard D6400 or D6868. They must also meet Federal Trade Commission (FTC) green guide labeling requirements and be labeled with a logo indicating a third party has certified that the product complies with ASTM specifications. The bill also prohibits labeling of most plastic products with the terms “biodegradable,” “degradable,” “decomposable,” or “oxo-degradable.”
- Food service products—along with certain film products—that meet ASTM composting standards must be “readily and easily identifiable.” This includes the use of a logo indicating the product has met ASTM standards and the inclusion of the word “compostable” where possible. On the other hand, food service products and film products—including film bags—that do not meet ASTM standards are prohibited from using tinting, labeling, and terms required of products that meet ASTM standards. The bill specifies that manufacturers or suppliers are not required to comply with any of the product labeling requirements that conflict with the FTC green guides.
- HB 1596 gives the state attorney general, cities, and counties concurrent authority to enforce the labeling and marketing requirements. If the bill is signed by the governor, it will become effective on July 1, 2020.
FSIS Proposes Changes to Net Weight/Net Contents for Some Meat and Poultry Packages
- In a proposed rule published on April 17, 2019, FSIS proposes to amend its labeling regulations to remove provisions that require packages of meat or poultry products that contain at least one pound or one pint, but less than four pounds or one gallon, to express the net weight or net contents in two different units of measurement on the product label. 84 FR 15989.
- Currently, under 9 CFR 317.2(h)(5) and 381.121(c)(5), dual declaration is required to express the net weight in ounces and immediately thereafter in parentheses in pounds, with any remainder in terms of ounces or common or decimal fraction of the pound (e.g., “Net Wt. 24 oz. (1 lb. 8 oz.), “Net Wt. 24 oz. (1.5 lbs.)” or “Net Wt. 24 oz. (1 1/2 lb.)”). The proposed rule would eliminate all of the provisions in 9 CFR 317.2(h) and 381.121(c) that require or cross-reference dual net weight or content statements, requiring only one unit of measurement on the product label.
- Comments on the proposed rule must be received on or before June 17, 2019.
FDA Allows Allulose to be Excluded From Sugar Declarations
- On April 18, 2019, FDA released a draft guidance for industry entitled, “The Declaration of Allulose and Calories from Allulose on Nutrition and Supplement Facts Labels.” The guidance announces FDA’s intent to exercise enforcement discretion for the exclusion of allulose from the amount of “Total Sugars” and “Added Sugars” declared on the label and the use of a general factor of 0.4 calories per gram for allulose when determining “Calories” on the Nutrition and Supplemental Facts labels.
- Allulose is a monosaccharide used as a sugar substitute in certain conventional foods and beverages. In a press statement, Dr. Susan Mayne, director of FDA’s Center for Food Safety and Applied Nutrition stated, “[t]he latest data suggests that allulose is different from other sugars in that it is not metabolized by the human body in the same way as table sugar. It has fewer calories, produces only negligible increases in blood glucose or insulin levels, and does not promote dental decay.”
- As a result of FDA’s announcement, the Agency’s decision is likely to generate more interest in allulose as a sugar substitute given the increasing pressure on industry to reduce sugar and calories.
FDA Accepts Qualified Health Claim Petition for Yogurt and the Reduced Risk of Diabetes
- FDA has accepted a qualified health claim petition submitted by Danone North America on the ability of yogurt to reduce the risk of type 2 diabetes. FDA is accepting comments on the petition until June 11, 2019.
- Danone is requesting FDA’s consideration of the following qualified claims: (1) “Eating yogurt regularly may reduce the risk of type 2 diabetes. FDA has concluded there is limited information supporting this claim;” or (2) “Eating yogurt regularly may reduce the risk of type 2 diabetes according to limited scientific evidence.”
- Danone has requested the claim only for yogurts meeting the standards of identity under 21 C.F.R. §§ 131.200 (“Yogurt”), 131.203 (“Lowfat yogurt”), and 131.206 (“Nonfat yogurt”). Thus, non-dairy yogurts will not be eligible to make the claim if the petition is successful.
FDA Announces New Tool to Alert the Public of Unlawful Ingredients in Dietary Supplements
- As our readers may remember, earlier this year the FDA announced a plan for modernizing and strengthening dietary supplement regulation and oversight. Under the plan, the FDA stated their intent to preserve consumers’ access to lawful supplements, while also upholding the Agency’s obligation to protect the public from unsafe and unlawful products. And as part of those efforts, on April 16, the FDA Deputy Commissioner for Food Policy and Response, Frank Yiannas, announced a new step to “better protect consumers from potentially unlawful dietary supplements.” The FDA launched a tool, called the “Dietary Supplement Ingredient Advisory List” (or “the List”), to quickly alert the public when the Agency becomes aware of ingredients that appear to be unlawfully marketed in dietary supplements.
- The List is intended as a resource for both consumers and industry, and as a means to communicate more efficiently and effectively with the public. For instance, the Deputy Commissioner acknowledged that “[a]s the dietary supplement marketplace has grown, the introduction of new ingredients often raises complex questions involving science, policy, and the law. In the time it takes the FDA to make a final determination, consumers and industry might mistakenly conclude that a lack of action by the FDA indicates that these ingredients are lawful.”
- Ingredients will be added to the List following an initial FDA assessment indicating the ingredient may not lawfully be in dietary supplements for reasons including: (1) the ingredient appears to be excluded from use in a dietary supplement; (2) the ingredient does not appear to be a dietary ingredient and does not appear to be either an approved food additive or generally recognized as safe for use; and/or (3) the ingredient appears to be subject to the requirement for pre-market notification, but the requirement has not been satisfied. The List currently includes the following four ingredients: andarine, higenamine, hordenine, and 1,4-DMAA.
- Notably, the inclusion of an ingredient on the List does not necessarily indicate safety concerns. Deputy Commissioner Yiannas stated the FDA will continue to communicate separately any time safety concerns about dietary ingredients or dietary supplements are identified. Additionally, the List is not exhaustive and is expected to evolve as new ingredients are identified. Thus, the FDA encourages consumer and industry feedback that may support or refute the FDA’s preliminary assessment regarding the ingredients on the List.
- The FDA also announced the issuance of 11 warning letters “to companies whose dietary supplement products are in violation of the law.” The FDA warned 8 companies for marketing dietary supplements containing DMHA. The products are adulterated because the FDA determined that DMHA is either a “new dietary ingredient” for which the FDA has not received the required New Dietary Ingredient notification or that it is an unsafe food additive. Additionally, the FDA warned 3 companies for marketing dietary supplements containing phenibut and stated that the products are misbranded because they label phenibut as a dietary ingredient when phenibut does not meet the statutory definition of a dietary ingredient. The companies have 15 business days from receipt of the warning letter to respond to the FDA.
Despite Gottlieb’s Exit, FDA’s Nutrition Innovation Strategy Marches Forward
- As previously reported on this blog, FDA’s Nutrition Innovation Strategy (NIS) is intended to improve public health via education regarding, and encouraging innovation in, the use of nutrition to promote health. The NIS was initiated under the leadership of FDA Commissioner Scott Gottlieb. Areas of emphasis are modernizing the approach to label claims, modernizing standards of identity, modernizing ingredient labels, and the use of healthy symbols. FDA held a public meeting on July 26, 2018 to discuss and solicit public input regarding the NIS. Our analysis of the comment submissions can be found here.
- With the impending departure of Dr. Scott Gottlieb as FDA Commissioner, in recent comments at the Grocery Manufacturers Association’s Science Forum, Claudine Kavanaugh, senior advisor for nutrition policy at FDA’s Office of Food Policy and Response made clear, “We are going to keep moving forward on the innovation strategy. There are no changes.” Ned Sharpless will carry forward the initiative as the recently-named Acting FDA Commissioner.
- As for next steps, Kavanaugh specifically highlighted modernizing claims, including the term “healthy,” where FDA is planning to publish a proposed rule this year updating the term and including a potential symbol to represent it. In addition, Kavanaugh noted the agency’s work to modernize the standard of identities (SOI), specifically mentioning the SOI for cheddar cheese as a focus moving forward. Kavanaugh also said the Agency is looking to reevaluate how ingredient information is presented on food labels and will roll out an education campaign to raise awareness for the new Nutrition Facts label.
Proposed Legislation Would Lock-In USDA’s Oversight of Cell-Based Meat
- As we previously reported, the United States Department of Agriculture (USDA) Food Safety and Inspection Service (FSIS) and the Food and Drug Administration (FDA) have issued a “Formal Agreement Between FDA and USDA Regarding Oversight of Human Food Produced Using Animal Cell Technology Derived from Cell Lines of USDA-amenable Species” (the press release can be found here). The agreement provides helpful answers regarding many regulatory aspects of the cell-cultured food industry, including the expected inspectional burdens for cell-based meat and poultry. The formal agreement between FDA and USDA, however, does not permanently bind either Agency as it could be revised as needed based on experience or funding considerations going forward.
- The Cell-Cultured Meat & Poultry Regulation Act of 2019 (S.1056), which was introduced last week by Senator Cindy Hyde-Smith (R, Mississippi), would amend the Federal Meat Inspection Act and the Poultry Products Inspection Act to formally and more permanently place regulation, inspection, and labeling of cell-cultured meat and poultry under FSIS jurisdiction. If the proposed legislation is enacted, FSIS and FDA will be required to issue final regulations within 18 months: (1) that prescribe the type and frequency of inspection required for the manufacture and processing of food products; and (2) for the prevention of the adulteration and misbranding of food products. With respect to labeling, the federal law contains language that could potentially make it easier for cell-based meat products to be called “meat” or “poultry” and it would preempt state laws that restrict the definitions of meat, poultry, chicken, etc. to potentially exclude cell-cultured meat products (see our blog post on the recently-passed Arkansas law).
- The bill was referred to the Senate Agriculture Committee for consideration, but the likelihood of passage is unclear. We will continue to track the regulation of cell-cultured food. Please feel free to contact Keller and Heckman at fooddrug@khlaw.com should you require further details regarding the potential impact of S.1056.
FDA Announces Public Meeting to Solicit Comments on Regulation of Dietary Supplements
- The Dietary Supplement Health and Education Act of 1994 (DSHEA) amended the Food, Drug, and Cosmetic Act to create the current regulatory framework for dietary supplements. At the time the law was passed, there were roughly 4,000 dietary supplements on the market in the United States. The number of dietary supplements on the market is now estimated to be between 50,000 and 80,000. Under DSHEA, producers of dietary supplements with new dietary ingredients must provide the Food and Drug Administration (FDA) with a premarket notification at least 75 days before introducing the product to market.
- Despite the increase of dietary supplements on the market of more than ten times what was on the market when DSHEA was passed 25 years ago, FDA has only received around 1,200 notifications for new dietary ingredients. While not all new dietary supplements include new dietary ingredients, FDA believes the relatively low number of notifications is due, in part, to an ineffective regulatory practice. As a result, on February 11, Dr. Scott Gottlieb, the then Commissioner of FDA, announced a new plan for dietary supplement oversight. As noted in the Daily Intake blog at the time, FDA has five steps it will implement:
- Develop new ways to communicate more quickly when FDA is concerned that an ingredient is unlawful and potentially dangerous and should not be marketed in dietary supplements.
- Ensure that the regulatory framework for dietary supplements is flexible enough to adequately evaluate product safety while promoting innovation.
- Undertake more collaborative research with industry.
- Continue to take actions to protect public health and develop new enforcement strategies.
- Establish public dialog on whether additional steps are necessary to modernize DSHEA.
- FDA announced in the April 11 Federal Register a May 16 public meeting to solicit input on regulation of dietary supplements in furtherance of the new plan for dietary supplement oversight. During that meeting, FDA hopes to discuss the following topics:
- The scope of the phrase “dietary substance for use by man to supplement the diet by increasing the total dietary intake”,
- Exceptions to the requirement for premarket notification and whether and how growth in the dietary supplements marketplace since 1994 has altered the impact of DSHEA,
- Potential commercial or marketing advantages to incentivize responsible innovation, and
- Promoting overall compliance with the premarket notification requirement through enforcement
- Registration to attend in person at FDA’s College Park campus is due by May 6. The meeting will also be streamed on webcast, though registration is required for the webcast as well.
