• On July 20, U.S. Senators Ron Wyden, D-Ore., Rand Paul, R-Ky., and Jeff Merkley, D-Ore., and U.S. Representative Earl Blumenauer, D-Ore., reintroduced legislation, called the “Hemp Access and Consumer Safety Act,” to ensure hemp-derived CBD products are regulated by the FDA like other substances used in dietary supplements and foods. In summary, the Act would:
    • Give hemp-derived CBD products an opportunity to lawfully be used in foods and dietary supplements under the FD&C Act;
    • Prioritize consumer safety, requiring manufacturers to comply with all existing federal regulations for the products that contain CBD; and
    • Ensure that these CBD products are properly labeled.
  • The reintroduction of the Act comes six months after FDA’s January 2023 statement regarding the Agency’s approach towards CBD and its application in the food and drug industry. Specifically, the FDA, with the help of a high-level internal working group, concluded that a new regulatory pathway for CBD was needed and that the Agency expects to collaborate with Congress on this matter, although a timeline for action was unknown.
  • Of the Act, Senator Wyden stated that “[d]espite being legally grown in the United States for nearly five years, hemp and hemp-derived CBD are still in a regulatory gray zone that puts consumers at risk and holds producers back. […] The FDA says it needs Congress to act. We’ve got the bill to ensure equal and safe access to hemp-derived CBD.” The bill is endorsed by various advocacy organizations and trade associations, including U.S. Hemp Roundtable, Wine and Spirits Wholesalers Association, Vote Hemp, and numerous others.
  • Keller and Heckman will continue to monitor and report on the progress of the bill.
  • Center for Drug Evaluation and Research (CDER) researchers recently conducted a study titled, The effect of food vehicles in vitro performance of pantoprazole sodium delayed release sprinkle formulation, to better understand the oral drug effectiveness when sprinkled onto or into certain foods.  “Sprinkling” a drug into food vehicles is a common alternative for patients who have difficulty swallowing solid foods or medications.  Previous research has shown that mixing incompatible foods and drugs may impact the drug’s rate of dissolution in the gastrointestinal tract, potency, and may even lead to undesired side effects.
  • Researchers focused on pantoprazole sodium (antacid), which patients are currently advised to mix with applesauce or apple juice, as supported by in vivo data described in the labeling.
  • The study evaluated several food vehicles and their effect on the in vitro performance (i.e., the process of dissolving in the body) of the drug.  Researchers chose apple juice and applesauce, as well as pudding, yogurt, and milk.  The foods differed in their viscosity (thickness), pH level (or how acidic/basic an item is), and water content. 
  • In the study, the researchers sprinkled the pantoprazole sodium granules on the food vehicles for different amounts of contact time (30, 60, or 120 minutes).  Then they placed the mixture into a dissolution apparatus for in vitro dissolution testing and took samples after various time periods.
  • Researchers found that the food’s pH and the length of time it was mixed with the drug affected drug performance.  When researchers mixed the drug into low pH food vehicles, such as applesauce or apple juice, the drug performed similarly to the control group.  Conversely, high pH food vehicles, such as milk, with a long contact time (e.g., 120 minutes) caused premature drug release, drug degradation, and loss of performance.  In conclusion, researchers confirmed that an in vitro assessment can detect the effect of the food vehicle on drug performance, which has implications for evaluating drug safety and efficacy.
  • Cell-cultured meat, also known as cultured meat, involves the production of meat from animal cells in a controlled environment. It has the potential to revolutionize the food industry by offering an alternative to traditional livestock farming, with potential benefits such as reduced environmental impact and improved animal welfare. Under the cooperative agreement between FDA and USDA, FDA will have jurisdiction over the preharvest production phase of the animal cell culture technology process, and jurisdiction will transfer to FSIS as the phase enters harvest, i.e., when the process halts the cell’s ability to further grow, multiply, or differentiate into other cell types.  FSIS jurisdiction will continue over the postharvest processing and labeling of cell-cultured meat.
  • As we have previously discussed, the successful FDA issuance of two “No Questions Letters” and USDA’s corresponding two labeling approvals for GOOD Meat and Upside Foods, has prompted FSIS to issue directives to its inspection program personnel (IPP) for future facility inspections.
  • All ingredients, including processing aids, used in products postharvest must be considered safe and suitable by FSIS and used in accordance with their intended use listed in 9 CFR 424.21(c) or FSIS Directive 7120.1. Approved ingredients are allowed to be added to cull-cultured meat food products, provided the intended use of those ingredients is consistent with its application, product type, and any other listed criteria. Any ingredient not listed in the above regulations must be submitted for review as described in FSIS Directive 5020.2.
  • Further, the issued directives inform IPP to refer to FSIS 5000.1 for comprehensive instructions on how to properly verify an establishment’s compliance with sanitation and the Hazard Analysis and Critical Control Point regulations. Additionally, IPP are directed to inspect the establishment’s harvesting and processing operations at least once per shift.
  • Finally, all cell-cultured meat product labels must be submitted to FSIS Labeling and Program Delivery staff for review and approval. FSIS Directive 7221.1 provides additional information for IPP to refer to on verification of the labeling requirements. Keller and Heckman will continue to monitor and report on developments impacting cell-cultivated meats.
  • Glyphosate’s current approval as an herbicide in the European Union (EU) is set to expire on December 15, 2023. In a decision which marked a key step towards a renewal of the approval, on July 7, 2023, the European Food Safety Authority (EFSA) published an updated risk assessment of glyphosate which concluded glyphosate can be used safely in agricultural practices. Though some risks were identified with certain uses, EFSA found no “critical areas of concern” for humans, animals, or the environment from using glyphosate in agriculture.
  • Glyphosate is a broadly used herbicide but is controversial due to differing opinions regarding its impacts on human health and the environment.
  • In 2015, the International Agency for Research on Cancer (IARC) classified glyphosate as “probably carcinogenic to humans” (Group 2A). In contrast, a 2020 interim decision by the Environmental Protection Agency (EPA) found there was “no risk of concern to human health” when glyphosate was used as intended and suggested the benefits of glyphosate outweigh potential ecological risks. That interim decision was vacated in part and withdrawn following a decision by the 9th U.S. Circuit Court of Appeals which found that EPA’s analysis had not met the agency’s legal obligations. However, EPA has indicated that its underlying conclusions, including that glyphosate is not likely to be carcinogenic to humans, remain the same and that it will more fully explain its analysis before issuing its final registration review decision, as part of a program that re-evaluates each registered pesticide on a 15-year cycle.
  • Keller and Heckman will continue to monitor and report on legal and scientific updates related to glyphosate.
  • On July 13, the FDA, USDA, and Department of Homeland Security (DHS), published the “120 Day Food and Agriculture Interim Risk Review,” which is a memorandum on strengthening the security and resilience of the US food and agriculture (FA) sectors against domestic and global threats. The interim risk review focuses on two primary goals:
    • To identify initial hazards and risks to the US food and agriculture (FA) sector
    • To identify initial mitigations actions to address those risks  
  • The interim risk review offers proposed short-term, mid-term, and long-term actions that could improve coordination and integration within the FA sector in strategic planning, information sharing and engagement, and understanding risks. Examples of the proposed actions include identifying communication gaps, improving sharing of threats, and convening a Food and Agriculture Defense Summit.
  • The interim risk review is a required part of the implementation of National Security Memorandum (NSM) 16, “Strengthening the Security and Resilience of United States Food and Agriculture,” which was signed by President Biden in November 2022. NSM 16 is intended to strengthen the FA sector by identifying and assessing threats, strengthening partnerships to enhance resilience, and enhancing preparedness and response. The interim risk review will be used to inform the Federal Risk Mitigation Strategy, which is also outlined in NSM 16.
  • On July 12, 2023, the U.S. Food and Drug Administration (FDA) released a public inventory of certain food ingredients that the agency has determined to have unsafe uses in food because they are unapproved food additives and lists of select chemicals currently under the agency’s review.  To supplement, FDA released a Conversations with Experts about the agency’s work to enhance the assessment of ingredients in foods on the market.
  • The inventory lists food ingredients that FDA has determined, from post-market evaluations, are not GRAS.  Under the Federal Food, Drug, and Cosmetic (FD&C) Act, any ingredient used or intended for use in food must be authorized by the FDA for use as a food additive unless that use is Generally Recognized as Safe (GRAS) by qualified experts, or meets a listed exception to the food additive definition in the FD&C Act.
  • The inventory includes the name of the unsafe food additive, information about some post-market activities and public communications, and the FDA’s memo that describes reviews in which the agency concluded the use of the ingredient did not meet the GRAS standard.  The post-market activities include warning letters, import alerts, seizures, and injunctions.
  • On July 9, 2023, Senator Schumer (D-NY) called for the FDA to investigate “PRIME” energy drinks due to their high caffeine content and direct marketing to children and teenagers.
  • PRIME is a popular beverage brand among younger populations, offering product lines geared toward post-workout recovery and energy.  The energy product line beverages contain 200 milligrams of caffeine in a 12-ounce serving and come in flavors such as “Ice Pop”, “Tropical Punch”, or “Blue Raspberry”.
  • FDA states healthy adults can consume 400 milligrams of caffeine per day without experiencing harmful negative effects but has not set an amount for children.  The American Academy of Child and Adolescent Psychiatry says there is “no proven safe dose of caffeine for children” and that teens between ages 12-18 should not have more than 100 milligrams of caffeine per day.  In response to Schumer’s call for action, PRIME released a statement supporting the drink’s safety indicating the beverage falls “within the legal limit of the countries it’s sold in” and that it had “complied with all the FDA guidelines before hitting the market.”
  • Currently, FDA does not have a specific category of regulation for energy drinks but companies are responsible for self-monitoring caffeine levels in their product and ensuring those levels are “safe under the intended conditions of use.”  FDA indicated it will respond to Schumer directly and that it may collaborate with the FTC to review PRIME’s marketing claims.
  • Keller and Heckman will continue to monitor developments in this space.
  • On June 27, 2023, the European Parliament’s Environment, Public Health and Food Safety Committee (ENVI) narrowly voted against a proposal to lower the maximum permitted limits for the food additives sodium and potassium nitrites (E 249-250) and sodium and potassium nitrates (E 251-252) because the proposed limits did not go far enough. Instead, a motion has been proposed that would ban the use of nitrites and nitrates in the EU following a four-year phase out period.
  • Nitrates and nitrites are widely used as preservatives in cured meat products such as bacon, ham, cold cuts, charcuterie, and some cheeses. Those in favor of a reduction and not a ban argued that nitrate/nitrite-free products are more expensive and therefore less accessible to some consumers.  In contrast, those in favor of a total ban cited the health concerns raised by the European Food Safety Authority (EFSA)’s January 2023 risk assessment on N-nitrosamines in food. N-nitrosamines are reaction products of nitrates and nitrites in certain food processing conditions. Many N-nitrosamines are genotoxic and carcinogenic and are associated with increased incidence of colorectal cancer.  However, the report also highlighted many uncertainties, including the levels at which N-nitrosamines are found in food products. 
  • The use of nitrates and nitrites as food additives has been restricted in certain EU member states such as in Denmark.  In the United States, nitrates are subject to a number of clearances, subject to certain limitations.  See e.g.  9 CFR 424.21(c) and 21 CFR 172.160, 172.170, and 172.175.
  • Keller and Heckman will continue to monitor the regulation of food additives in the EU.

  • Delta-8 Tetrahydrocannabinol (Delta-8 THC) is an isomer of Delta-9 THC, the intoxicating component of certain cannabis plants.  It is naturally occurring at very low levels in hemp and can be synthetically manufactured by chemical conversion of cannabidiol (CBD) extracted from hemp.  We have discussed a September 14, 2021 consumer update, “5 Things to Know about Delta-8 Tetrahydrocannabinol – Delta-8 THC,” that was issued by FDA after an uptick in adverse event reports, findings of Delta-8 THC products marketed to children, and contamination concerns from potentially unsafe manufacturing methods.  FDA’s first warning letters for products labeled as containing Delta-8 THC were announced on May 4, 2022, as discussed here. 
  • On July 5, 2023, in a coordinated effort with the Federal Trade Commission (FTC), FDA announced the issuance of six warning letters for adulterated food violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and unfair or deceptive marketing violations of the FTC Act related to adding Delta-8 THC to conventional foods.  The products at issue in the new warning letters are candy (e.g., sour worms and gummy bears), chips, cookies, and other snack foods that FDA says intentionally mimic well-known snack food brands (i.e., Doritos, Oreos, Cheetos, Jolly Rancher, and Nerds) by using similar brand names, logos, or pictures on packaging that consumers, especially children, may confuse with traditional snack foods.  FDA is also concerned that adults could unintentionally consume these products or take a higher dose than expected and suffer serious consequences, and notes this risk is especially dangerous for those who are driving, working, or have other responsibilities. 
  • All Delta-8 THC products at issue were found by the agencies’ review of the companies’ websites where customers could place orders for the products.  Safety concerns raised by FDA and FTC suggest that enforcement against these kinds of products containing Delta-8 THC will remain a priority.  Keller and Heckman will continue to monitor and report on regulatory developments related to cannabis-derived ingredients.