Often mislabelled botanical sports supplements

A whopping 89 percent of sports supplements with botanical ingredients that purportedly have performance-enhancing properties didn’t have accurate ingredient labels, and 12 percent contained FDA-prohibited substances, according to new research.

Of the 57 products tested, 40 percent had no detectable levels of the advertised botanical ingredient on the label, reported Pieter Cohen, MD, of the Cambridge Health Alliance in Somerville, Massachusetts, and co-authors.

Among products that had detectable levels of the listed ingredient, the actual amount ranged from 0.02% to 334% of the labeled amount, they noted in a research letter published in JAMA network open.

“What you see when you take a close look at the products is that it’s really a hot mess. There’s just a wide variation between having absolutely nothing in there — not even plant-based ingredients on the label — to more than three times the plant-based ingredient on the label,” Cohen said MedPage Today. “But even more concerning was that we found that more products had FDA-prohibited drugs than actually contained what was listed on the label.”

Cohen and his team found five FDA-prohibited substances, including four synthetic stimulants, 1,4-dimethylamylamine, deterenol, octodrine, oxilofrine and omberacetam. Alarmingly, one product contained four banned ingredients.

“Only 11% of the products had the right ingredient at the right dose,” Cohen said.

The FDA doesn’t approve supplement ingredients the same way they do for drugs. The authors noted that FDA inspections often find supplement manufacturers “fail to meet basic manufacturing standards, such as establishing the identity, purity or composition of the final product.”

Cohen explained that manufacturers may be inclined to include stimulants in their products because the research supporting botanical ingredients isn’t conclusive or robust. He also explained that having unlisted synthetic stimulants can pose a threat to consumers.

“If you have an abnormal increase in these types of stimulants, particularly in your heart, you may be at a higher risk of having heart complications with exercise,” she said.

He and his co-authors concluded that “physicians should alert consumers that supplements that list botanical ingredients with purported stimulant or anabolic effects may not be accurately labeled and may contain FDA-prohibited drugs.”

In terms of next steps, Cohen thinks the FDA needs a reform that allows it to pre-screen supplements before they hit the shelves.

“Currently, the system is set up so that the only way the FDA will know anything is happening is if the products have been on the market for a significant amount of time. We will need to change that and try to understand the mechanisms by which we can detect dangerous supplements, even before they are marketed,” he said.

In invited commentary, Peter Lurie, MD, MPH, of the Center for Science in the Public Interest in Washington, DC, explained that chronic underfunding and the Dietary Supplement Health and Education Act (DSHEA) of 1994 contributed to why the FDA is understaffed to regulate supplements.

“Although supplement manufacturing facilities are required to register with the FDA, they are under no obligation to provide the agency with a list of their products or what they contain,” Lurie wrote, adding that “companies can introduce new dietary supplement ingredients without even notifying the agency and can simply self-certify the ingredients as safe.”

In the nearly 30 years since DSHEA was enacted, the number of unique supplement products on the market has soared to 95,000 from just 4,000, he noted.

This research “underscores the need for Congress to take action and increase oversight of supplements marketed and distributed in the United States,” Lurie concluded.

Even David Light, founder and CEO of Valisure, a pharmacy and laboratory that tests prescription drug products, agreed that the current system doesn’t work.

“Independent testing of supplements and all pharmaceutical products is a critical missing piece of consumer protection in the United States,” said Light, who was not involved in the research. “The FDA is responsible for the safety and efficacy of these products, but they can’t reasonably do it themselves and should do a better job working on and encouraging independent testing.”

For example, in Europe, he noted, the Official Medicines Control Laboratory helps with quality control.

“It’s clear from this study, and others looking at various supplements, that the supplement industry suffers from a worrying lack of regulation and independent review,” Light said.

For this study, Cohen and colleagues analyzed products, all purchased online, that listed at least one of five botanical ingredients: Rauvolfia vomitoria, methylliberine, turkesterone, halostaquine or octopamine. The product powder was reconstituted in methanol and analyzed for the presence and quantity of the five ingredients and FDA-prohibited ingredients by liquid chromatography quadrupole time-of-flight mass spectrometry.

In total, Cohen and team analyzed 57 products, with 13 listed R. vomitoria21 methylliberine listed, eight turkesterone listed, seven halostakine listed, and eight octopamine listed.

The authors noted that the sample size was small and only analyzed one sample from each brand. Therefore, their findings may not apply to all products containing these botanical ingredients, and it is possible for ingredient amounts to vary between batches of a product.