Warning Letter

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Navigating the legal landscape of weight loss supplements

By Danielle Masterson

Over 42% of adults in the US are considered obese—giving weight loss brands easy marketing fodder amid the obesity epidemic. Unfortunately, this category of supplements has a checkered history, and has become labeled as one of FDA's problem children.

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Warning letters continue as pandemic rages on

By Danielle Masterson

The Federal Trade Commission has sent out another round of warning letters to 50 more marketers nationwide, most of which are labeled as dietary supplements or Chinese herbs.

Use of aromatase inhibitor forms basis of warning letter

Use of aromatase inhibitor forms basis of warning letter

By Hank Schultz

A recently posted warning letter cites a New York company for the presence of an aromatase inhibitor in one of its dietary supplements. This class of chemicals is popular with strength trainers for its purported ability to suppress estrogen levels.

FDA uses warning letter to check up on DMAA recall

FDA uses warning letter to check up on DMAA recall

By Hank Schultz

In an unusual move, in a warning letter to a dietary supplement company the Food and Drug Administration has sought information about a recall, in this case one involving DMAA products.

Whey maker gets warning on inflammation claims

Whey maker gets warning on inflammation claims

By Hank Schultz

A recent warning letter issued by the Food and Drug Administration makes clear the danger marketers run into when using the words “inflammation” and “chronic” in the same breath, even in connection with an unusual product for that sort of claim, such...

FDA issues new DMAA warning letter

FDA issues new DMAA warning letter

By Stephen Daniells

The US Food and Drug Administration (FDA) has issued another warning letter for DMAA, with Irvine, CA-based Regeneca receiving the letter for its RegeneSlim product.

FDA ‘motivates’ firms to correct violations

FDA ‘motivates’ firms to correct violations

By Lorraine Heller

A warning letter close-out process implemented this month by the US Food and Drug Administration (FDA) hopes to encourage firms to take corrective action – but so far even responses to warning letters are lacking.

When foods become drugs

When foods become drugs

By Lorraine Heller

As the year draws to a close, NutraIngredients-USA.com looks at occasions where the US FDA has intervened to clear up the food, drink and supplement industries of products that overstep the fine line between function and pharmaceutical.

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