Most botanical sports supplements tested in study didn’t meet label claim; banned ingredients also found

A new study from a group led by prominent industry critic Dr. Pieter Cohen, M.D., has found mislabeling and the presence of banned ingredients in a suite of botanical sports nutrition supplements. 

The new research was published in the journal JAMA Network Open. The research group was led by Dr. Cohen, of Harvard Medical School, and experts from the University of Mississippi and NSF who have collaborated with him in the past. 

The researchers assembled a suite of products to test that were labeled to include popular botanical sports nutrition ingredients. Those ingredients were: Rauwolfia vomitoria,  methylliberine, turkesterone, halostachine, or octopamine.  

R. vomitoria is a species of shrub that reportedly has been used in some traditional medicine systems. Promoters of the other four listed ingredients have claimed botanical heritage for them. The JAMA study did not delve into the question of whether these compounds were in fact derived from botanical sources or were synthetic analogs. 

Few products met label claim 

The researchers analyzed 57 products that listed one of the five ingredients on the label. They tested the products for potency as well as for the presence of banned sports nutrition ingredients. 

They found that only 11% of the products, or six of the 57 total, were in the ballpark of meeting label claim, i.e., within 10%, plus or minus, of the stated amount of the ingredient. 

Related:Pieter Cohen: Current Supplement AER System Inadequate

Of the rest, 23, or 40%, had no detectable amount of the main ingredients. Of those in which some of the sports ingredient could be detected, amounts ranged from 0.2% to 334% of label claim. 

Banned substances found 

In addition to testing for potency, the supplements were subjected to a banned substances test. The tests revealed seven of the 57 products (or 12%) contained at least one of the following five prohibited compounds: 1,4-dimethylamylamine (DMAA), deterenol, octodrine, oxilofrine, and omberacetam. One of the products tested was found to contain four of these compounds. 

“Given these findings, clinicians should advise consumers that supplements listing botanical ingredients with purported stimulant or anabolic effects may not be accurately labeled and may contain FDA-prohibited drugs,” the researchers concluded. 

Call for mandatory product listing 

The journal also invited Dr. Peter Lurie, M.D., head of the Center for Science in the Public Interest, to draft a comment that was published alongside Cohen paper.  Lurie reiterated a demand for a premarket product listing requirement as a bare minimum to adequately police a market that, according to FDA, has ballooned to 95,000 individual products. 

“As the work by Cohen et al demonstrates, supplements often do not contain what is advertised or, more concerning, contain ingredients that may not be safe for consumers. This work underscores the need for Congress to take action and increase oversight over supplements marketed and distributed in the United States,” Lurie wrote. 

Lurie noted there is some support within the industry for the concept of a mandatory product listing (MPL).   Among those is the Council for Responsible Nutrition (CRN).

Steve Mister, CEO of CRN, said Dr. Cohen's latest paper breaks no new ground in identifying the existience of poor quality products that can be found for sale online.

“Unfortunately, this research letter offers little that we don’t already know. Once again, Pieter Cohen has shown that if you look hard enough, products of questionable quality, containing obscure or illegal substances, can be found online. And once again, we call on FDA to shine a light into the dark corners of the Internet and hold the manufacturers of these kinds of products accountable," Mister said in an emailed statement.

FDA could find bad actors if it so chose 

One group that has consistently argued against MPL is the Natural Products Association (NPA). 

“One thing about the commentary that is factually inaccurate is that FDA can issue a recall on a dietary supplement. It’s always this cry for more authority,” said Daniel Fabricant, Ph.D., NPA’s president and CEO. 

“The sample isn’t representative of the industry. I’m confident none of these products were made in an NPA-member facility,” Fabricant said. “The key issue is enforcement. If Cohen can find these products, FDA can, too.”