FDA should expand EMA definition: AHPA

In comments filed on August 3, AHPA said that clarification was needed on the definition so EMA addresses products that are marketed as dietary supplements but that contain undeclared drug ingredients.

“AHPA applauds FDA’s actions against ‘spiked’ weight-loss and other products that are marketed as dietary supplements but found to contain prescription drugs,”​ said Michael McGuffin, president of AHPA.

“It is obvious that enforcement action is needed against these bad actors, and it is also clear that these products are intentionally adulterated for financial gain,”​ he added.

FDA proposed a working definition of economically motivated adulteration in its April 6 notice as:

• “EMA [is] the fraudulent, intentional substitution or addition of a substance in a product for the purpose of increasing the apparent value of the product or reducing the cost of its production, i.e., for economic gain. EMA includes dilution of products with increased quantities of an already present substance (e.g., increasing inactive ingredients of a drug with a resulting reduction in strength of the finished product, or watering down of juice) to the extent that such dilution poses a known or possible health risk to consumers, as well as the addition or substitution of substances in order to mask dilution.”

AHPA suggests that the words “a product”​ be changed to “an ingredient, component, or product”​.

The trade association also suggests that the addition of the phrase: “EMA also includes, but is not limited to, the addition or substitution of substances in order to allow an adulterated ingredient or product to conform to identity and other quality tests used for genuine articles, or in order to have a physiological effect that is dependant upon the added or substituted substance.”​

A suggestion was also made to require all companies receiving product in manufactured form to test the identify of the products, under dietary supplement Good Manufacturing Practice (GMP).

“Any EMA is always threat to public health because there is no assurance that adulterants used are safe,”​ said AHPA General Counsel Tony Young.

“Now that FDA has held its public meeting and received stakeholder comment, we should expect to see the law enforced as it was always intended to be enforced.”​

To read AHPA's full comment, please click here.

CRN speaks​

Only last week, another trade association, the Council for Responsible Nutrition (CRN), said that EMA of dietary supplements is a “serious and growing concern” in a climate of inadequate testing methods and substandard raw materials.

Responding to a now-closed call for comment from the Food and Drug Administration (FDA), CRN highlighted new GMP regulations as being a step in the right direction, but noted ingredient suppliers remained under the rule of food GMPs, not the GMPs that came into force two years ago.