- 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 ENFORCEMENT
FDA Releases Q&A for Preventive Controls for Animal Foods
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- In light of the approaching September 17, 2018 compliance date for small animal food businesses (i.e., those with less than 500 full-time equivalent employees) to comply with Hazard
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Senators Urge FDA to Get Tough on Flavored Vaping Products
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- Fourteen senators, including Senate Minority Whip Dick Durbin (D-IL), have sent a letter to FDA criticizing the agency for what it characterizes as lax enforcement that has allowed children to
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FDA to Issue a Guidance Document Limiting Use of Milk in Plant-Based Beverages
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- In the 2018 POLITICO Pro Summit, FDA Commissioner Scott Gottlieb signaled that FDA will begin collecting comments regarding enforcement of standard of identity for “milk”. As noted in our
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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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FDA and FTC Take Enforcement Action on E-Liquids That Resemble Foods
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- FDA has joined the Federal Trade Commission (FTC) in issuing warning letters to 13 companies that market nicotine-containing e-liquids in packaging that has the appearance of being foods that appeal
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FDA Targets Highly Concentrated Caffeine in Dietary Supplements
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- As previously reported on this blog in 2015, FDA warned that it intended to “aggressively monitor the marketplace for pure powdered caffeine products and take action as appropriate.” The Agency
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FDA Issues First Warning Letter Based on “Serious Violations” of Part 117 CGMP Regulations
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- On March 16, 2018, FDA issued a warning letter to Bhavani Fruits and Vegetables LLC in Maspeth, New York for “serious violations” of Current Good Manufacturing Practice (CGMP) requirements under
FDA oversees destruction and recall of kratom products
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- On February 21, FDA issued a press release announcing the voluntary destruction and recall of a large volume of kratom-containing dietary supplements manufactured and distributed nationwide under the brand names
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E-Commerce Enforcement
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FDA takes significant action to stop illegal drug sales online.
- FDA has broad regulatory authority over the marketing of food, drugs, medical devices, and cosmetics in the U.S. Although many