Pressure Mounts on FDA to Regulate Fake Amazon Dietary Supplements

Dietary supplements have become a staple for many Americans. In 2023, United States residents spent a near 45 billion on dietary supplements, according to Grand View Research. However, pressure from lawmakers is being placed on the FDA to ensure products are as advertised.

U.S. South Carolina Congressman Jeff Duncan has sent a letter to the Food and Drug Administration (FDA) asking why the federal agency hasn’t responded to NOW Foods’ dietary supplement tests that raise questions about the authenticity of some products available on Amazon.

In his letter, shared with Healthnews, he wrote, "I believe [the] FDA's failure to act on information from credible sources in this matter has consequences."

NOW Foods manufactures and distributes more than 1,500 dietary supplements, natural foods, sports nutrition, and personal care products. Since 2017, Now Foods has been testing unfamiliar dietary supplement brands available on Amazon.

Most recently, NOW Foods released test results of berberine supplements, which has gained popularity on TikTok for its ability to aid weight loss. NOW Foods evaluated 33 berberine supplements from Amazon and Walmart.com, including their own. Each brand was assessed by high-performance liquid chromatography with ultraviolet light detection to detect the amount of berberine in each product.

NOW Foods found that 18 of the 33 brands tested contained less than 40% of the labeled potency of berberine. Seven brands had less than 1% or less of berberine, manufacturers included Earth Bare, Greabby Gummies, GreenPeople Formula, KoNefancy, Satoomi, Vitamiscence, and Wellness Labs Rx.

NOW Foods tested 22 astaxanthin products last summer from the same e-commerce platforms. Astaxanthin is an antioxidant associated with healthy aging properties. The dietary supplement distributor found that 14 of the samples failed the potency testing. All but one of those samples failed to contain at least 1mg of the advertised 24 mg of astaxanthin.

In an interview with NutraIngredients USA on April 15, NOW Foods CEO Jim Emme revealed his company had met with FDA officials to discuss some of the latest supplement testing earlier this year.

“We had a discussion about some of the latest testing and on what some of the barriers could be. In that point, they asked us how we determined what products were fraudulent,” Emme said. “We basically do it economically, we know what the cost of active ingredients are, we are big enough that we get really good pricing on them, and we know for a fact very quickly that you can extrapolate whether that active ingredient is in there or not.”

Rep. Duncan is a member of the House Committee on Energy and Commerce. In a letter dated April 12 to FDA Commissioner Dr. Robert Califf, Duncan criticizes the agency for not taking action despite receiving evidence from NOW Foods and other supplement manufacturers.

He wrote, "More consistent enforcement would promote the agency's mission of protecting the public health."

Emme told NutraIngrediets USA he is thankful to have the help of bipartisan support in Washington D.C.

It is important that the Energy and Commerce Committee be aware of what is happening out there. We have been doing this testing for several years now of supplements we found sold on Amazon. We have looked at some other problems, but Amazon is where we have seen problems where we know there is economic adulteration going on.

Emme

Emme says NOW Foods notifies supplement manufacturers when their products rate poorly during testing. He notes the worst offenders are the ones who don’t respond, highlighting the need for the FDA to provide some form of enforcement.

The FDA’s website highlights that it does have the authority to protect the public from adulterated dietary supplements if manufacturers and distributors fail to fulfill their responsibility to ensure that adulterated products don’t make it to market.

The FDA emphasizes it is limited to postmarket action because no law provisions exist that order the agency to approve dietary supplements before they go to the user, unlike prescription drugs that require approval by the FDA. The agency says it does evaluate reports sent by manufacturers and distributors of dietary supplements regarding the adverse effects of their products.