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Tag: Dietary Supplements

FDA Advises Consumers to Avoid Using Dietary Supplements with Undeclared Drug Ingredients

Adverse Events, Dietary Supplements, Enforcement, FDAFDA

On April 7, 2014, the U.S. Food and Drug Administration (“FDA”) advised consumers to stop taking Zi Xiu Tang Bee Pollen products, which are promoted as body forming, weight loss dietary supplements. According to the FDA, the Company’s dietary supplements …

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FDA Moves to Update Nutrition Facts Label for Foods

Beverages, Dietary Supplements, FDA, Food, LabelingFDA

On February 27, 2014, the U.S. Food and Drug Administration’s (“FDA”) moved to update nutrition facts labels (“Nutrition Facts Panels”) on packaged foods and dietary supplements. The proposal was prompted by recent scientific findings that suggest there is a direct …

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FDA Issues Statement on IOM Report on Safety of Caffeine in Foods

Beverages, caffeine, Dietary Supplements, Enforcement, FDAFDA

On January 21, 2014, the U.S. Food & Drug Administration (“FDA”) issued a Statement on the Institute of Medicine’s Report (“IOM Report”) on Caffeine in Foods. Released on January 17, 2014, the IOM Report is a culmination of the recent …

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FDA Issues Guidance on Distinguishing Liquid Dietary Supplements from Beverages

Beverages, Dietary Supplements, FDA, Food, GRAS, Labeling, Structure-Function ClaimsFDA

On January 16, 2014, the U.S. Food & Drug Administration (“FDA”) published a guidance document entitled “Distinguishing Liquid Dietary Supplements from Beverages” (“Guidance”). Found here, the Guidance is aimed at explaining to industry how dietary supplements and beverages differ. Beverages …

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FDA Warns Consumers About Dietary Supplement Containing Synthetic Steroids

Adverse Events, dietary ingredients, Dietary Supplements, Disease Claims, Drugs, Enforcement, FDA, Warning LettersFDA

On December 23, 2013, the U.S. Food and Drug Administration (“FDA”) issued an announcement warning consumers about the serious health risks associated with using “Mass Destruction,” a product marketed as a dietary supplement for muscle growth. This product is manufactured …

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U.S. Marshals Seize Dietary Supplements Containing DMAA from Georgia Company

Dietary Supplements, DMAA, Enforcement, FDA, New Dietary Ingredients, Warning LettersFDA

On November 12, 2013, the U.S. Marshals, at the request of the U.S. Food and Drug Administration (FDA), seized dietary supplements manufactured and held by Hi-Tech Pharmaceutical, Inc., located in Georgia. According to the FDA, the dietary supplements are adulterated …

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FDA Seeks Permanent Injunction against Oregon Dietary Supplement Company

CGMP, Dietary Supplements, Disease Claims, Structure-Function ClaimsFDA

On October 21, 2013, the U.S. Food and Drug Administration (“FDA”) announced that it is seeking a permanent injunction against James G. Cole, a dietary supplement manufacturer based in Oregon, along with the company’s president, James G. Cole, and general …

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FDA’s CFSAN Announces Plan for Program Priorities

Beverages, CFSAN, Cosmetics, Dietary Supplements, FDA, Food, Food Safety Modernization Act, Gluten-Free, Guidance, LabelingFDA

On September 4, 2013, the Center for Food Safety and Applied Nutrition (CFSAN or the Center), a public health regulatory center in the U.S. Food and Drug Administration (FDA), published its 2013-2014 Plan for Program Priorities. The plan outlines certain …

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FDA Issues Warning Letters to Companies Marketing Illegal Diabetes Drugs

Dietary Supplements, Disease Claims, Drugs, Enforcement, FDA, Labeling, Structure-Function Claims, Warning LettersFDA

On July 23, 2013, the U.S. Food and Drug Administration (FDA) announced that it issued warning letters to 15 domestic and foreign companies that were deemed to be unlawfully marketing diabetes products in violation of the Federal Food, Drug, and …

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FDA Investigates the Safety of Caffeine in Food

Beverages, Dietary Supplements, FDA, FoodFDA

On May 3, 2013, the U.S. Food and Drug Administration (FDA) announced that it is currently investigating the safety of added caffeine in foods, particularly in response to a recent trend of caffeinated products. The FDA is primarily concerned with …

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    Katherine L. Giannamore
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