- On April 18, 2019, FDA released a draft guidance for industry entitled, “The Declaration of Allulose and Calories from Allulose on Nutrition and Supplement Facts Labels.”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.
USDA Pushes Back Against Washington Post Over New Swine Slaughter Inspection System
- On February 1, 2018, FSIS put forward a proposed rule to establish a voluntary, opt-in inspection system for market hog slaughter establishments, called the New Swine Slaughter Inspection System (NSIS). Under the proposed rule, hog slaughter plants may voluntarily join a new inspection system whereby establishment personnel would be responsible for sorting and removing unfit animals and identifying defects before FSIS inspection. FSIS inspectors who currently perform this function would be moved to other areas of the plant focused more on food safety. FSIS online inspectors would be reduced to a maximum of three per line per shift. The rule also specifically proposes to lift caps on line speeds in processing plants.
- On April 3, the Washington Post published an article critiquing the proposed NSIS, “Pork industry soon will have more power over meat inspections.“ The article states that the “power and responsibility for food safety inspection in hog plants” is planned to shift to the pork industry, cutting the number of federal inspectors by 40 percent and replacing them with plant employees. The article uses USDA’s proposal to highlight what it considers a larger issue: the acceleration of the federal government’s move toward deregulation and reducing regulations.
- In an unusual move for the agency, on April 8, 2019, FSIS released a response to the article, condemning it for false reporting. Specifically, FSIS clarified that only federal inspectors perform meat inspections and will continue to conduct 100% ante-mortem inspections and 100% carcass-by-carcass inspection at post-mortem. The agency will make staff determinations on a case-by-case basis and will not be decreasing inspectors by 40 percent. Under the proposal, establishment employees sort market hogs before FSIS inspection, which is consistent with current policy for establishments under traditional inspection. You can find FSIS’s response to the Washington Post and clarifications on the proposed rule here.
USDA’s FSIS Publishes Updated Food Date Label Fact Sheet To Curb Food Waste
- As previously covered on this blog, food waste is a major issue in the United States. Government estimates indicate Americans waste between 30 and 40% of the overall food supply on an annual basis. According to the USDA, consumers are responsible for nearly 90 billion pounds of food waste each year, which equates to 20% of the U.S. food supply. And while perfectly good food goes to waste, approximately 40 million Americans are food insecure.
- Misinterpretation of food date labels is a key factor leading to food waste. Indeed, as explained by FDA’s Deputy Commissioner, Frank Yiannas, “[c]ontrary to popular beliefs, date labeling on food packages are often intended to communicate time ranges for optimal food quality, not safety.” With an exception of infant formula, even after the date passes, a product should still be safe and wholesome if handled properly until the time spoilage is evident. Thus, in an effort to alleviate confusion and prevent further food waste, USDA’s FSIS announced an updated fact sheet on food product dating. See 84 Fed. Reg. 14083 (Apr. 9, 2019). The fact sheet is aimed at reducing food waste through encouraging food manufacturers and retailers that apply product dating to use a “Best if Used By” date label because research shows that this phrase is easily understood by consumers as an indicator of quality rather than safety.
- The fact sheet explains that, except for infant formula, food date labels are not required under federal regulations. For meat, poultry, and egg products under FSIS jurisdiction, dates may be voluntarily applied provided they are labeled in a manner that is truthful and not misleading and in compliance with FSIS regulations. The fact sheet further details that because there is no uniform or universally accepted food date label descriptor, a wide variety of phrases are used to describe quality dates. Examples include:
-
- “Best if Used By/Before” date indicates when a product will be of best flavor or quality. It is not a purchase or safety date.
- “Sell-By” date tells the store how long to display the product for sale for inventory management. It is not a safety date.
- “Use-By” date is the last date recommended for the use of the product while at peak quality. It is not a safety date except for when used on infant formula as described below.
- “Freeze-By” date indicates when a product should be frozen to maintain peak quality. It is not a purchase or safety date.
- As an aside, the USDA, EPA, and FDA announced April as “Winning on Reducing Food Waste Month” and called for greater collaboration with public, private, and nonprofit partners, as well as state and local officials to educate consumers and stakeholders throughout the supply chain on the need to reduce food loss and waste. The interagency strategy includes six key priority areas the agencies will work together on over the next year:
- Enhance Interagency Coordination
- Increase Consumer Education and Outreach Efforts
- Improve Coordination and Guidance on Food Loss and Waste Measurement
- Clarify and Communicate Information on Food Safety, Food Date Labels, and Food Donations
- Collaborate with Private Industry to Reduce Food Loss and Waste Across the Supply Chain
- Encourage Food Waste Reduction by Federal Agencies in their Respective Facilities
FDA Announces Citizen Petition to Grant Fiber Status to IMO
- As our readers are aware, in May 2016, FDA issued final rules to implement changes to the nutrition labeling and serving size regulation. The final rules regarding nutrition labeling established a definition for the term “dietary fiber.” In March 2018, FDA published final guidance on dietary fiber that communicated the Agency’s revised standard of review of the scientific evidence that shows non-digestible carbohydrates (NDCs) have a beneficial physiological effect on human health. Then, as previously reported on this blog, FDA announced on June 15, 2018, that it had responded to five citizen petitions requesting that additional NDCs be added to the definition of “dietary fiber,” including one for isomaltooligosaccharides (IMOs), which the Agency denied. (FDA did grant fiber status to three of the substances that were the subject of those Citizen Petitions.)
- FDA received a Citizen Petition on March 4, 2019, from Top Health Ingredients, Inc., requesting that IMO be included within the list of dietary fibers identified in 21 C.F.R. §101.9(c)(6)(i). The petition identifies IMOs as glucose oligomers that contain D-(1,6)-linkages and cites two requirements for including IMO within the list of “dietary fibers.
- The food substance must be composed of isolated or synthetic non-digestible carbohydrates with 3 or more monomeric units and
- The food substance must be the subject of a petition submitted to FDA under 21 C.F.R. §10.30 demonstrating that such carbohydrates have a physiological effect that is beneficial to human health.
- The petition continues to explain how IMO satisfies both of those requirements. The beneficial physiological effects cited are reductions in blood cholesterol concentrations and improved laxation. More information on the petition, including how to comment, can be found here.
Latest FDA Data Show Foodborne Pathogens in Fresh Herbs, Guacamole, and Processed Avocado; The Source of a New Multistate E. coli O103 Outbreak Remains a Mystery
- In 2014, the Food and Drug Administration (FDA) began random sampling and testing of a variety of commodities from domestic and foreign sources to learn more about the prevalence of disease-causing bacteria. The first commodities sampled were sprouts, whole fresh avocados, and raw milk cheese (aged 60 days), followed by cucumbers and hot peppers. Each commodity was tested for Salmonella, Listeria monocytogenes, and E. coli O157:H7. Hot peppers were also tested for Shiga-toxin producing E. coli (STEC). Summary Reports are available for FY16-17 Hot Peppers, FY14-16 Whole Fresh Avocados, FY14-16 Raw Milk Cheese Aged 60 Days, and FY14-16 Sprouts. Interim Data are available for FY16 Cucumbers. As previously reported on this blog, Salmonella was detected in 15 of the 1,050 cucumber samples, while Listeria monocytogenes and E. coli O157:H7 were not detected in any of the samples.
- On April 4, 2019, FDA released data from testing of 747 fresh herb samples (basil, parsley, and cilantro) and 526 processed avocado or guacamole samples for bacterial pathogens. Nine fresh herb samples tested positive for Salmonella (4 domestic, 5 import) and six tested positive for STEC, which further testing showed were not capable of causing severe illness. E. coli O157:H7 was not detected in any of the fresh herb samples. Cyclospora cayetanensis, which was tested only in herbs harvested in summer months, was detected in two of 141 samples of domestically grown fresh herbs tested and four of 74 samples of imported fresh herbs. Of the processed avocado or guacamole samples, 11 tested positive for Listeria monocytogenes and two tested positive for Salmonella.
- FDA uses data from the microbial surveillance sampling program to identify potential vulnerabilities and ways to enhance the food safety system. Follow up inspections or corrective actions may be taken when a sample tests positive for a pathogen. For example, the detection of Listeria monocytogenes-positive samples of avocado pulp resulted in FDA refusing entry of avocados from lots associated with the positive samples and FDA put the responsible firms and their product on Import Alert 99-23. While FDA builds this important database, foodborne disease outbreaks continue to occur on a regular basis. On April 5, 2019, the Centers for Disease Control and Prevention (CDC) posted an Investigation Notice of a new multistate outbreak of Shiga toxin-producing Escherichia coli (E. coli) O103 infections of 72 people, with 8 hospitalizations and 0 deaths reported from March 2 – March 29, 2019. No specific food item, grocery store, or restaurant chain has been identified as the source of infections.
