FDA Enforcement Actions Following Findings in Food Facility Inspections of “Serious Violations” of CGMP Requirements in 21 CFR Part 117

We previously reported on FDA’s March 16, 2018 warning letter to Bhavani Fruits and Vegetables LLC for “serious violations” of Current Good Manufacturing Practice (CGMP) requirements under 21 CFR Part 117.  This is believed to have been the first time FDA formally cited Part 117 CGMP regulations promulgated under FSMA in a warning letter (as … Continue Reading

Proposed Class Action Alleges Company’s CBD Products Violate Federal Law (subscription to Law360 required)

As our readers may recall, on November 25, FDA issued warning letters to 15 companies for illegally selling FDA-regulated products containing cannabidiol (CBD) in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). FDA alleged that CBD lacks an appropriate regulatory status in the products and, in some cases along with product claims, … Continue Reading

FDA and FTC Send Warning Letter for Marketing Unapproved Drugs and Dietary Supplements Containing CBD

On October 10, the FDA and FTC sent a joint warning letter to Rooted Apothecary LLC for illegally selling unapproved drug products containing cannabidiol (CBD) online with unsubstantiated claims that the products treat teething pain and ear aches in infants, autism, attention-deficit/hyperactivity disorder (ADHD), Parkinson’s and Alzheimer’s disease, among other conditions. As described in the … Continue Reading

FDA Issues Warning Letters to Companies Illegally Selling Unapproved, Misbranded Kratom Products

On June 25, FDA issued warning letters to two marketers and distributors of kratom products – Cali Botanicals and Kratom NC. FDA determined that the companies were illegally selling unapproved, misbranded kratom-containing drug products with unproven claims about their ability to treat or cure opioid addiction and withdrawal symptoms. Additionally, FDA found that the companies … Continue Reading

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 … Continue Reading

FDA Action Against Dietary Supplements Containing Tianeptine Signals Renewed Focus on Protecting Consumers from Dietary Supplements with Unauthorized Drug Claims

  The Dietary Supplement Health and Education Act of 1993 (DSHEA) was intended to provide a framework for FDA to regulate dietary supplements.  DSHEA established a new category of permitted claims for dietary supplements called “statements of nutritional support.”  Claims of mitigating or treating a disease, however, are “drug claims” and are not permitted on … Continue Reading

FDA Announces Continued Kratom Safety Concerns and Issues Warning Letters to Kratom Marketers

In a press announcement released on September 11, 2018, FDA Commissioner Scott Gottlieb, M.D., emphasized the Agency’s continuing concerns about kratom products. Our readers may remember our previous posts about kratom, also known as Mitragyna speciosa, which is a plant that grows naturally in Thailand, Malaysia, Indonesia, and Papua New Guinea. According to FDA, there … Continue Reading

FDA Issues First Warning Letter for Alleged HARPC Violations

On July 26, 2018, FDA posted its first Warning Letter citing Kerry, Inc. for alleged violations of the Hazard Analysis and Risk-Based Preventive Controls (HARPC) and Current Good Manufacturing Practice (CGMPs) provisions at 21 CFR Part 117. While FDA has cited violations of the revised CGMP regulations in prior Warning Letters, this appears to be … Continue Reading

FDA Again Targets Bulk Quantities of Pure or Highly Concentrated Caffeine Sold to Consumers as Dietary Supplements

  As previously reported on this blog, FDA sent Warning Letters to five companies that distributed pure powdered caffeine in 2015 and advised that it intended to “aggressively monitor the marketplace for pure powdered caffeine products and take action as appropriate.”  FDA stated in the letters that it concluded that pure powdered caffeine is adulterated … Continue Reading

FDA Warns Companies Illegally Marketing Dietary Supplements as Sunscreen

On May 22, 2018, FDA sent warning letters to companies illegally marketing dietary supplements that make unproven drug claims about sun protection without meeting FDA’s standards for safety and effectiveness. FDA said the companies are “putting people’s health at risk by giving consumers a false sense of security that a dietary supplement could prevent sunburn, … Continue Reading

FDA Warns Bakery to Fix cGMP Violations and Remove the “Love”

On September 22, 2017, following an inspection of the company’s manufacturing facility, the U.S. Food and Drug Administration (FDA) issued a warning letter to Nashoba Brook Bakery regarding significant current Good Manufacturing Practice (cGMP) violations.  cGMPs describe the methods, equipment, facilities, and controls for producing food.  cGMPs prescribe the minimum sanitary and processing requirements for … Continue Reading

Supplement Stimulant Spotlight

FDA warns companies marketing dietary supplements that contain methylsynephrine. As previously covered on this blog, FDA has the authority to take enforcement action against unlawfully marketed and/or dangerous dietary ingredients in dietary supplements.  In the last year, FDA has taken action against beta-methylphenethylamine (BMPEA), 1,3-Dimethylbutylamine (DMBA), and kratom, to name a few prominent examples. FDA recently sent Warning … Continue Reading

Cannabidiol: (Clinical) Trials and Tribulations

FDA issues Warning Letters to eight companies marketing cannabidiol products. As previously covered on this blog, FDA released a 2015 Q&A document stating its views that cannabidiol (CBD) products are excluded from the dietary supplement definition due to the existence of known substantial clinical investigations on this substance.  This is the so-called “drug exclusion” from … Continue Reading

Cough Up the Caffeine

FDA issues Warning Letters to five distributors of powdered caffeine alleging safety risks inherent to product use. FDA regulates the marketing of dietary supplements.  Under Section 402(f)(1)(A)(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), a supplement is adulterated when it “presents a significant or unreasonable risk of illness or injury under…conditions of use recommended … Continue Reading

FDA Burns Tobacco

FDA issues Warning Letters to three tobacco manufacturers regarding “additive-free” and “natural” claims. FDA has the authority to regulate various tobacco products (cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco) under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act of 2009 (Tobacco Control … Continue Reading


FDA cites “Just Mayo” products for non-compliance with the standard of identity for mayonnaise, among other issues. Startup company Hampton Creek previously has faced criticism and legal challenges related to its decision to market an eggless mayonnaise substitute under the name, “Just Mayo.”  Critics have argued that the labeling and marketing are likely to result … Continue Reading

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