WARNING LETTER
FDA and FTC Send Warning Letter for Marketing Unapproved Drugs and Dietary Supplements Containing CBD
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- 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
FDA Calls on Papaya Industry to Take Action to Prevent Foodborne Illness Outbreaks
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- On August 26, the FDA issued a letter to all sectors of the papaya industry to take action to prevent future foodborne illness outbreaks. As noted in the letter, since
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FDA Issues Warning Letters to Companies Illegally Selling Unapproved, Misbranded Kratom Products
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- 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
FDA Announces New Tool to Alert the Public of Unlawful Ingredients in Dietary Supplements
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- 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
FDA Action Against Dietary Supplements Containing Tianeptine Signals Renewed Focus on Protecting Consumers from Dietary Supplements with Unauthorized Drug Claims
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- 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
FDA Announces Continued Kratom Safety Concerns and Issues Warning Letters to Kratom Marketers
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- 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
FDA Issues First Warning Letter for Alleged HARPC Violations
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- 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
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FDA Again Targets Bulk Quantities of Pure or Highly Concentrated Caffeine Sold to Consumers as Dietary Supplements
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- 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
FDA Warns Companies Illegally Marketing Dietary Supplements as Sunscreen
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- 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.
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