- On January 6, 2025, the U.S. Food & Drug Administration (FDA, or the Agency) issued a final guidance ,“Action Levels for Lead in Processed Food Intended for Babies and Young Children: Guidance for Industry” which aims to regulate lead levels in processed foods for infants and toddlers under two years old.
- As we have previously blogged, in 2021, FDA initiated its Closer to Zero policy which identified actions the Agency will take to reduce exposure to toxic elements, including lead, to as low as possible while maintaining access to nutritious foods.
- As part of this initiative, FDA has also evaluated mercury, cadmium, and arsenic in foods intended for babies and young children, as well as lead in juices. Under this initiative, FDA has prioritized babies and young children as they are especially vulnerable to lead exposure, which accumulates in the body over time.
- Lead is naturally present in the environment, but human activities have also released elevated levels of lead, contaminating soil, water, and air. This contamination can affect crops used in food production.
- Lead exposures can lead to developmental harm to children by causing learning disabilities, behavioral difficulties, lowered IQ, and may be associated with immunological, cardiovascular, and reproductive and or/developmental effects.
- To address this concern, FDA established the following action levels in the final guidance for processed foods intended for babies and young children:
- 10 parts per billion (ppb) for fruits, vegetables (excluding single-ingredient root vegetables), mixtures (including grain- and meat-based mixtures), yogurts, custards/puddings, and single-ingredient meats;
- 20 ppb for single-ingredient root vegetables; and
- 20 ppb for dry infant cereals.
- If a processed food intended for babies and young children reaches or exceeds the aforementioned levels of lead, the product will be considered adulterated within the meaning of section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
- After publishing the final action levels, the Agency will establish a timeframe for assessing industry’s progress toward meeting the action levels and resume research to determine whether the scientific data supports efforts to further adjust the action levels.
Tag: FDC Act
FDA Issues Warning Letters to 7 Dietary Supplement Companies for Drug Claims
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On November 17, 2022, FDA posted warning letters to 7 companies for selling different dietary supplements with claims that caused the products to be “drugs” in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Under the FD&C Act, products intended to diagnose, cure, treat, mitigate, or prevent disease are drugs and are subject to the requirements that apply to drugs, even if they are labeled as dietary supplements.
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The claims were found on the 7 companies’ websites, social media pages, and/or Amazon or Walmart storefronts, and included a variety of statements regarding the products’ claimed abilities to cure, treat, mitigate, or prevent cardiovascular disease (or related conditions, such as atherosclerosis, stroke, or heart failure). Six of the companies at issue sell a product(s) containing one or more dietary ingredients identified as Vitamin B3, red yeast rice, pine bark extract, EPA and DHA omega-3 fatty acids, magnesium, zinc, bergamot, Hawthorn berry, Hawthorn extract, Coleus forskohlii, hops, taurine, garlic powder, amino sulfonic acid, Co-Q-10, and/or octacosanol. The seventh company does not list a dietary ingredient but identifies its product as a “glycocalyx regenerating product” and notes various “pathologies associated with impaired endothelial glycocalyx.” As noted in the warning letters, FDA has not evaluated whether the unapproved products are effective for their intended use, the proper dosage, potential interaction with FDA-approved drugs or other substances, or whether they have dangerous side effects or other safety concerns. Further, in addition to characterizing the products as unapproved “new drugs,” FDA’s letters note misbranding charges based on the impossibility of writing adequate directions for a layperson to use the products safely for the intended purpose of treating one more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner.
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FDA requested that the companies respond to the warning letters within 15 working days and describe how they will address the issues, or provide reasoning and substantiation as to why they believe the products are not in violation of the law. Failure to adequately address could result in legal action, such as product seizure and/or injunction.
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FDA and FTC Issue Warning Letters to CBD Companies
- On March 28, 2022, the Food and Drug Administration (FDA) and Federal Trade Commission (FTC) jointly issued seven warning letters to companies marketing cannabidiol (CBD) products with COVID-19 related claims.
- Specifically, the agencies warned the following companies regarding the promotion of their respective products with claims that they cure, mitigate, treat or prevent COVID-19: Cureganics, Heaven’s Organics LLC, Functional Remedies, LLC D/B/A Synchronicity Hemp Oil, Greenway Herbal Products LLC, CBD Social, UPSY LLC, and Nature’s Highway. Examples of claims include: “Our research suggest that CBD . . . can block SARS-Cov-2 infection at early and even later stages of infection. . .”, “Studies Show CBD Compounds Prevent COVID Cells From Replicating”, and “Can CBD Help with the Fight Against COVID? Some of the worst effects of COVID are caused by inflammation, and CBD is a potent anti-inflammatory.”
- By way of background, under the Federal Food, Drug, and Cosmetic Act (FD&C Act), products intended to cure, treat, mitigate, or prevent disease are considered drugs and are subject to the requirements that apply to drugs. Therefore, the agencies classified the products as unapproved and misbranded drugs that may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA.
- The letters included a cease-and-desist demand from FTC, prohibiting the companies from making such COVID-19 related claims. The companies were provided with 48 hours to respond with specific steps that were taken to correct the violations.
Article By Food and Drug Law Practice Group at Keller and Heckman LLP
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