• Today, FDA announced that it will be holding a virtual listening session on June 1, 2023 for interested parties to consult cosmetics manufacturers, including smaller businesses, contract manufacturers, consumer organizations, and other experts to help inform FDA’s efforts in developing regulations to establish good manufacturing practices (GMPs) for facilities that manufacture, or process cosmetic products distributed in the United States.
  • The event will include preliminary introductions and brief remarks on cosmetic product GMPs, followed by public comments on cosmetic GMPs.
  • To facilitate the discussion, FDA has developed topics covering the types of information the Agency seeks to obtain from industry, including:
    • Cosmetic GMPs
      • Identify any national or international standard and the extent to which it would be practicable for GMP regulations for cosmetic products;
      • Describe what constitutes sufficient flexibility within GMPs for cosmetic products to ensure regulations are practicable for all sizes and types of facilities;
      • Describe what constitutes simplified GMPs requirements for cosmetic products for smaller businesses to ensure regulations do not impose undue economic hardship; [and]
      • Describe appropriate compliance times for GMP regulations.
    • GMP Economic Impact
      • To what extent are manufacturers of cosmetic products already following a national or international standard for GMPs?  If an entity is not currently following a standard, what would the cost to implement GMPs consistent with such standard be?
      • Provide reports or examples of adverse events or recalls associated with a cosmetic product that were linked to manufacturing practices. How would implementing GMPs impact the likelihood of a recall of cosmetics products?  How would implementing GMPs impact the likelihood of consumers experiencing adverse events from the use of cosmetics products?  How would these impacts differ by type of cosmetic product?
  • Interested parties may register for the event at this link. The session will take place on June 1, 2023 from 10AM- 1PM EST.
  • Keller and Heckman will continue to monitor and report on FDA activity impacting the cosmetic industry.
  • As we previously blogged, in February FDA published a long-awaited draft guidance document which laid out a voluntary framework on the labeling of plant-based milk alternatives. The guidance, which has been criticized by both the plant-based milk and the dairy industry, proposed to allow the use of the term “milk” in non-dairy products provided that the plant source and nutritional differences from milk are disclosed.
  • The original 60-day comment period ended yesterday (April 24th). However, in response to requests from both the plant and the dairy industry, FDA announced that it would be extending the comment period to a date that will be determined when the extension notification is published. We note that the requests asked for either 60- or 90-day extensions.
  • Apart from citing the need for additional time to consider the guidance and develop meaningful comments, many of the comments also noted that FDA relied on consumer studies, some of which are not publicly available and must be obtained through a Freedom of Information Act (FOIA) request. The comments indicated that the studies have not yet been obtained through FOIA due to a backlog in the system. We will continue to monitor any developments.
  • FDA’s first action concerning the labeling of “online grocery” was a 2007 ‘‘Dear Manufacturer’’ letter that recommended consistency with FDA’s current regulatory requirements for labeling of food packages.  Subsequently, FDA’s October 2021 ‘‘New Era of Smarter Food Safety Summit on E-Commerce: Ensuring the Safety of Foods Ordered Online and Delivered Directly to Consumers’’ (Summit) included a session focused on the nutrition, ingredient, and major allergen information that is displayed through online grocery shopping platforms.  Since that time, FDA has become increasingly concerned about the food label information that is available to consumers through online grocery shopping platforms, including grocery retailer (e.g., supermarket) websites, manufacturer’s websites, and third-party online grocery providers. 
  • On April 21, 2023 FDA posted a Constituent Update on a Request For Information (RFI) that was published today about the content, format, and accuracy of food labeling information provided through online grocery shopping platforms.  FDA has posed specific, enumerated questions regarding: 
  1. Food Labeling Information Provided Through Online Grocery Shopping
    • What mandatory label information is currently available?
    • How consistently is mandatory label information presented across different platforms?
    • How is nutrition, ingredient, and major food allergens information presented, e.g., where is it available on the web page in relation to the product?
    • When provided, is the nutrition, ingredient, and major food allergens information in the same format as on the packaged product (e.g., Nutrition Facts label format)?
    • If pictures of the product are used, what ensures the information in the picture is consistent with the package label, and is readable and accessible on all devices?
  2. Industry Considerations and Logistics of Food Labeling in Online Grocery Shopping
    • How do manufacturers, grocery retailers, and third-party online grocery providers decide what label information to display?
    • What challenges and limitations are encountered when seeking to display food labeling information?
    • What, if any, are the labeling challenges for international websites?
    • How is information online ensured to be accurate, up to date, and consistent with the product package?
    • How are reformulations addressed that may alter a product’s nutrition, ingredient, or major food allergens information?
    • If a change or error is detected, how is the information collected and the website updated, e.g., is there a customer feedback loop or internal quality assurance process?
    • What measures are taken to ensure that consumers can access accurate nutrition, ingredient, and major food allergens information?
    • Are there opportunities to leverage online platforms (e.g., interactive labeling) to improve consumer engagement with and accessibility to food labeling information?
    • How is equitable online access to labeling information ensured for consumers?
    • Do current online labeling presentations present barriers to accessing labeling information for certain consumers?
  3. Consumer Use of Food Label Information in Online Grocery Shopping
    • What food label information do consumers expect to see, e.g., all the same information as the retail food package label?
    • When there is a picture of a product label online, do consumers expect the picture of the label to be the same as the label on the retail food package?
    • To what extent, and how, do consumers use nutrition, ingredient, and major food allergens information, e.g., to support eating healthier?
    • What percentage of consumers – identified by demographic data if possible – use the label information because of specific dietary concerns?
    • What do consumers find most challenging about navigating online shopping platforms for specific label information needs?
    • What data are available on the most effective ways for presenting nutrition, ingredient, and major food allergens information that consumers find useful?
    • What are effective means of displaying this information on the platform to ensure consumers have ready access?
  • There is no specific information on the timing or type of follow-up action FDA may take regarding food labeling in on-line grocery shopping.  Comments on FDA’s RFI are due by July 24, 2023.  FDA asks responders to provide any data and evidence to support their responses and to identify the question by its number (such as 1.1) when responding.  FDA will also consider comments relevant to on-line food labeling that were received in a public docket established for the 2021 Summit.  Please let us know if you are interested in submitting comments on this topic.
  • On April 17, 2023, the U.S. Supreme Court declined to hear the Council for Education and Research on Toxics’ (CERT) request to review a decision blocking new lawsuits under California’s Proposition 65 (Prop 65), which requires cancer warning labels on foods containing acrylamide.  The Court passed on deciding whether a California federal judge’s order barring the state attorney general and public interest groups from filing new suits constitutes “an unlawful prior restraint on the exercise of the organizations’ First Amendment petition rights.” 
  • The order at the center of CERT’s bid came from a lawsuit filed by the California Chamber of Commerce against the state attorney general seeking to cancel Prop 65 label requirements, saying they amount to false compelled speech in violation of the U.S. Constitution.
  • Previously, in March 2021, U.S. District Judge Kimberly J. Mueller held that the state government was compelling commercial speech by requiring businesses to identify the chemical as a “known” carcinogen on labels because there are conflicting reports from scientific sources about whether the chemical actually increases the risk of cancer in humans.
  • A three-judge panel for the Ninth Circuit upheld the preliminary injunction in March 2022.  CERT asked the Ninth Circuit to review en banc the panel’s decision, which was denied in October.
  • On April 5, the Food and Agriculture Organization of the United Nations (FAO), in collaboration with the World Health Organization (WHO), issued a joint global report to engage with respective Members and relevant stakeholders by proactively sharing the current knowledge to identify concrete ways to inform consumers and all other stakeholders about the food safety considerations for cell-based food products. Cell-based food production, which is the field of growing animal agricultural products directly from cell cultures, has been explored as a sustainable alternative to the conventional livestock agricultural system.
  • In consultation with experts in the field, FAO and WHO identified potential hazards in the four stages of the cell-based food production, namely:
    • 1) cell-sourcing;
    • 2) cell growth and production;
    • 3) cell harvesting; and
    • 4) food processing.
  • Experts agreed that while many hazards are already well known and existing equally as well in conventionally produced food, the focus may need to be put on the specific materials, inputs, ingredients (including potential allergens), and equipment that are unique to cell-based food production.
  • The report emphasizes the need for more data generation and sharing on a global scale, providing that the path forward includes investing in research and develop in order to understand whether the alleged benefits in increased sustainability can be realized. In this regard, it will be important to closely observe as to what extent cell-based foods result in differences from conventionally produced foods.
  • Lastly, FAO and WHO acknowledged that the potential risk of a negative public opinion about cell-cultured meat is already a cause for concern for industry, explaining that “implementation of vigilant hazard/risk assessments, control measures, transparency and effective risk communication are important strategies for mitigating these risks.” The report recommend industry holding focus groups and actively reaching out to consumers to the public’s questions and concerns regarding this new food space.
  • Keller and Heckman will continue to report on the evolvements in the cell-based food industry.
  • Earlier this month, the Center for Science in the Public Interest (CSPI), a nonprofit with a mission to improve public health through better nutrition and safer food, petitioned FDA to take various actions to reduce sodium in food, including finalizing a 10-year target for sodium reduction in processed, packaged, and prepared foods.
  • CSPI has a history of pushing FDA to take action on sodium reduction. FDA’s 2016 draft guidance with voluntary 2- and 10-year sodium reduction targets for processed, packaged, and prepared foods was issued in response to a petition and subsequent lawsuit by CSPI.  In 2021 FDA issued a final guidance document which established voluntary 2.5-year sodium targets for processed, packaged, and prepared foods to reduce average daily sodium intake to 3,000 mg/day, but it did not finalize a 10-year target, establish intermediate reduction steps, or describe how industry compliance would be monitored.
  • CPSI’s latest petition requests that FDA:
    • Issue final guidance identifying a voluntary 10-year sodium-reduction target in processed, packaged, and prepared foods by April 2025.
    • Simultaneously establish an intermediate voluntary sodium reduction target.
    • Publish a plan which details how industry compliance with the voluntary targets will be monitored.
    • Identify products which are the largest contributors to sodium intake and maintain a public database of these products.
  • CSPI argues that the lack of intermediate or long-term targets has led to industry uncertainty and that the failure to establish such targets will hamper progress in reducing the levels of sodium in the food supply. However, we note that FDA has taken other recent action on reducing sodium levels, including proposing changes to standards of identity to allow for salt substitutes. We will continue to monitor and report on FDA’s action regarding sodium reduction.
  • FDA regulates human and animal food from plants, including plants produced through genetic engineering (GE), under the Federal, Food, Drug, and Cosmetic Act (FD&C Act).  Foods derived from new plant varieties, both GE plants as well as varieties from traditional plant breeding, must meet the same FDA regulatory requirements that apply to all foods.  FDA has established a voluntary Plant Biotechnology Consultation Program whereby companies may submit notices, which FDA reviews and responds to with respect to whether food derived from a new plant variety presents safety and regulatory issues.  One of the factors that FDA considers is whether a protein expressed by a new plant variety may cause an allergic reaction because adverse reactions to food allergens can be severe and life-threatening, including when the allergen is present at low levels. 
  • In an April 13, 2023 Constituent Update, FDA announced that a letter was sent to manufacturers and developers of new plant varieties who intend to transfer genes for proteins that are food allergens (including allergens from foods identified as major food allergens) into new plant varieties used for food.  FDA cautions these developers to consider the food safety risks posed by such allergens and plan early in development to manage the risks.  Although meat is not a major allergen, plant-based proteins made by adding a gene for an allergenic animal protein to a new plant variety are called out in FDA’s letter as an example of GE that could result in the presence of an unexpected allergen in another food made with a new plant variety as an ingredient.  The only other cautionary example provided in FDA’s letter is the historical case of a Brazil nut gene that was transferred into a soy variety to improve its nutritional profile for animal feed, in which case development was voluntarily discontinued based on the developers’ concerns that they could not ensure the modified soybean would not inadvertently get into human food.  In this regard, FDA’s letter reminds developers to consider allergenicity issues related to their products, and how they would be stewarded from production to manufacturing to consumption so that they do not inadvertently or unexpectedly enter the food supply and how their products need to be properly labeled when intentionally part of the food supply.  FDA’s letter also cautions that if unexpected and unlabeled allergens enter the food supply, this could have other consequences for food producers, such as needing to recall the affected products.
  • FDA’s letter does not explain how the presence of an allergen is likely to be “unexpected and unlabeled” in the case of proteins from new plant varieties that are being developed as plant-based substitutes for animal proteins, such as collagen, myoglobin, ovalbumin or casein that are used in currently marketed foods containing these proteins.  The larger issue would seem to be unintended spread of a gene for an allergenic protein to non-GE crops.  For example, we have discussed how genetic material from two new GE varieties of canola seed was found in specific lots of non-GE canola seed and a small number of non-GE canola fields before voluntary premarket consultations with FDA for the GE canola were completed.  In this case, new proteins expressed in the canola were found unlikely to be allergenic and the issue of preventing unintended spread to non-GE crops (which is in the jurisdiction of USDA’s Animal and Plant Health Inspection Service (APHIS)), was not addressed in FDA’s favorable response letters on the GE canola.
  • On April 13, 2023, the U.S. Food and Drug Administration (FDA) is issuing a final order to modify the yogurt standard of identity final rule, published on June 9, 2021. 
  • FDA has denied the International Dairy Foods Association’s (IDFA) request for a public hearing and is issuing a final order to modify the final rule with respect to maximum pH.  FDA has amended the yogurt standard acidity requirement to require products to have a pH of 4.6 or lower, so as to ensure the safety of yogurt while maintaining its basic nature and essential characteristics.
  • In December 2022, FDA made modifications to the rule to allow the use of all safe and suitable sweeteners, including non-nutritive sweeteners, and to make the minimum optional fortification of Vitamin D 10% of the Daily Value.  FDA also modified the general definition and standard of identity under 21 CFR 130.10 to permit the use of fat-containing flavors (such as coconut flakes, chocolate, etc.) in lower fat yogurt).
  • The final rule is effective on April 14, 2023 and the compliance date is January 1, 2024.  Additional details can be found in the Federal Register notice.
  • As we previously blogged, a California bill co-sponsored by Consumer Reports and the Environmental Working Group (EWG) and now being debated in the California State Assembly would, if passed, ban five chemicals from being used as additives in food and drinks sold in the state. See Assembly AB 418.
  • On April 11, the California Assembly Health Committee met to consider the bill first introduced in February by Assembly members Jesse Gabriel and Buffy Wicks. The bill was one of 25 heard by the Committee without a quorum present, meaning a “do pass” recommendation is presently pending. The legislation seeks to prohibit the manufacture, sale, delivery and distribution of food products that contain brominated vegetable oil, potassium bromate, propylparaben, red dye 3, and titanium dioxide. These targeted additives commonly found in foods marketed for children consumption have been approved by FDA, but are presently banned in the European Union due to claims that they are allegedly linked to cancer, behavioral health problems, and harm to the reproductive system.
  • If the bill is enacted, California would become the first state to ban chemical additives from food. After the Assembly Health Committee, AB 418 goes to the Assembly Environmental Safety and Toxic Materials Committee.
  • Keller and Heckman will continue to monitor the developments of AB 418 and will update accordingly.

  • As we have previously blogged, last month FDA indicated that it would publish a proposed rule amending the standards of identity (SOIs) of foods in which salt (i.e., sodium chloride) is a mandatory or optional ingredient to allow for the use of salt substitutes. Yesterday, FDA published the proposed rule in the Federal Register with comments due by August 8, 2023 (120 days from publication).
  • The proposal allows for the use of salt substitutes in standardized foods and rather than specifically list salt substitutes, it defines “salt substitute” broadly to include any safe and suitable ingredient or combination of ingredients which is used to replace salt and which does not alter the essential characteristics of the food. This approach is intended to cover both ingredients that are currently used as salt substitutes (e.g., potassium chloride), as well as ingredients that in future will be used as salt substitutes (without the need for additional rulemaking). We note that the rule does not propose to amend the SOI for oysters in 21 CFR 161.130 since FDA’s understanding is that industry uses readily available seawater during the shucking process and does not add salt. FDA is requesting comment on its understanding of this process.
  • Currently, the only option for most manufacturers who would like to lower the salt content of standardized foods which reference salt is to make a nutrient content claim, but this requires a very significant reduction in salt content which is often difficult to achieve (e.g., a “reduced sodium” claim requires a 25% reduction). We note that there are a few SOIs for low sodium foods which already allow for the use salt substitutes (e.g., 21 CFR 133.116 (“low sodium cheddar cheese”)).
  • The proposed rule is part of FDA’s continuing efforts to improve nutrition and reduce intake of sodium, which increases risk of high blood pressure, a leading cause of heart disease and stroke. Americans consume an average of 3,400 mg of sodium per day, which is almost 50% more than the 2,300 mg/day recommendation adopted by the Dietary Guidelines for Americans, 2020-2025. 70% of this consumption comes from sodium added during manufacturing and commercial food preparation.
  • We will continue to monitor and report on FDA’s efforts to modernize SOIs and improve nutrition.