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Malcolm Spicer

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Plan to market kratom product prompts FDA to send NDI warning

Industrial Chemicals’ planned Feb. 28 launch of a kratom product prompted FDA, in its latest enforcement targeting the herb, to remind the firm that it has not shown that extract from the ingredient is safe for use in a dietary supplement.

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'Big shoes to fill' as Hatch retirement leaves supplement market legacy

Sen. Orrin Hatch (R-Utah) won’t seek re-election and will leave 24 years after Congress passed the Dietary Supplement Health and Education Act (DSHEA) as a framework for FDA's regulation of vitamin, mineral and supplement product manufacturing and marketing. Hatch is in his seventh term and is the longest-serving Senate member.
US Food Policy Food Safety and Standards

Amarin's omega-3 fair trade complaint reaches regulatory dead end

The International Trade Commission (ITC) has agreed it's FDA's job to regulate the dietary supplement industry as it rejected Amarin Corp. PLC's fair trade complaint, alleging some omega-3 ingredients are unapproved new drugs.

US Food Policy Food Safety and Standards

Compiling pre-DSHEA ingredient list relies on bridging FDA-industry gap

"Nobody said these are easy questions, if they were they would have been answered a long time ago," said Steve Tave, director of FDA's Office of Dietary Supplement Programs (ODSP), referring to FDA's struggle to come up with a "grandfathered" dietary ingredient list. Industry stakeholders at an Oct. 3 public meeting recommended a reasonable threshold for evidence that verifies a dietary ingredient was available in the U.S. before Congress passed the Dietary Supplement Health Education Act (DSHEA).

US Food Policy Food Safety and Standards

Gottlieb looks like good fit at FDA helm to supplement industry

Scott Gottlieb’s two stints at FDA and his support for limiting regulation that impedes innovation bode well for a supplement industry, which is anxiously awaiting a guidance on New Dietary Ingredient (NDI) notifications.

US Food Policy Food Policy

Energizing Jelly Beans deliver 'sweet side' but not 'faster run' – NAD

Sports Beans Energizing Jelly Beans shouldn't claim to make athletes faster while appealing to their sweet tooth, says the National Advertising Division (NAD).

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