Tag Archives: DSHEA

11th Circuit Rules for Plaintiffs in Class Action Lawsuit Based on Economic Loss From Purchase of ‘Worthless’ Supplements Containing DMBA – an Impermissible NDI

  We previously reported on a flurry of FDA enforcement actions in 2015 based on adulteration per se, which followed years of relative inaction in the dietary supplement marketing arena outside of enforcement against products with specific health or safety concerns.  FDA’s enforcement actions included warning letters to 14 companies regarding the marketing of products … Continue Reading

FDA to Strengthen Dietary Supplements Regulation

On February 11, FDA Commissioner Scott Gottlieb, M.D. announced a new plan for modernizing and strengthening dietary supplement regulation and oversight. In making the announcement, Dr. Gottlieb pointed out that supplement use is increasing with three out of every four American consumers taking a dietary supplement on a regular basis. Also, since Congress passed the … Continue Reading

FDA Announces October Meeting on Pre-DSHEA List

Manufacturers or distributors of new dietary ingredients (NDIs) must submit a pre-market notification called a new dietary ingredient notification (NDIN) to FDA at least 75 days before marketing a dietary supplement that contains an NDI (i.e., one not marketed in the U.S. prior to October 15, 1994).  On August 12, 2016, FDA issued a revised Draft Guidance on … Continue Reading

Down on DMBA

FDA issues flurry of Warning Letters to companies marketing DMBA as a dietary ingredient in dietary supplements. By law, a “dietary ingredient” is defined as a vitamin; a mineral; an herb or other botanical; an amino acid; a dietary substance for use by humans to supplement the diet by increasing the total dietary intake; or … Continue Reading

FDA Bumps BMPEA

FDA takes enforcement action against BMPEA. In recent weeks, we have seen increased media coverage regarding concerns about beta-methylphenethylamine (BMPEA) in dietary supplements in the United States.  Congressmen have urged FDA to take enforcement action and a major supplement trade association has imposed a “no-sale” policy for BMPEA supplements as a condition of membership.  Many have … Continue Reading
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