A staggering 89% of sports supplements with botanical ingredients that supposedly have performance-enhancing properties did not have accurate ingredient labels, and 12% contained FDA-prohibited substances, according to new research.
Of the 57 products analyzed, 40% did not have detectable levels of the botanical ingredient touted on the label, reported Pieter Cohen, MD, of Cambridge Health Alliance in Somerville, Massachusetts, and co-authors.
Among the products that did have detectable levels of the listed ingredient, the actual quantity ranged from 0.02% to 334% of the labeled quantity, they noted in a research letter published in JAMA Network Open.
“What you see when you actually 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 ingredients on the label — to more than three times the plant ingredient on the label,” Cohen told MedPage Today. “But even more concerning was the fact that we found that more products had prohibited FDA drugs than actually contain 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 prohibited ingredients.
“Only 11% of products had the right ingredient at the right dose,” Cohen said.
The FDA does not approve supplement ingredients the same way it does for drugs. The authors noted that FDA inspections often find that supplement manufacturers “fail to comply with 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 surge of these types of stimulants, particularly to the heart, you might be at higher risk of having cardiac complications with exercise,” he said.
He and his co-authors concluded that “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.”
In terms of next steps, Cohen thinks the FDA needs reform that allows it to pre-screen supplements before they hit the shelves.
“Currently, the system is set up so that the only way that the FDA would know that something is happening is that the products are on the market for a significant amount of time. We’re going to need to change that and try to figure out mechanisms by which we can detect dangerous supplements — even before they’re marketed,” he said.
In an invited commentary, Peter Lurie, MD, MPH, of the Center for Science in the Public Interest in Washington, D.C., explained that chronic underfunding and the Dietary Supplement Health and Education Act (DSHEA) of 1994 contributed to why the FDA is underpowered to regulate supplements.
“While supplement manufacturing facilities must register with FDA, they are under no obligation to provide a list of their products, or what they contain, to the agency,” 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 ballooned to 95,000 from just 4,000, he noted.
This research “underscores the need for Congress to take action and increase oversight over supplements marketed and distributed in the United States,” Lurie concluded.
David Light, founder and CEO of Valisure, a pharmacy and lab that tests prescription drug products, also agreed that the current system isn’t working.
“Independent testing of supplements and all pharmacy products is a critical missing piece of consumer protection in the United States,” said Light, who was not involved with the research. “FDA is responsible for the safety and efficacy of these products, but it cannot reasonably do this alone, and should do a better job of working with and encouraging independent testing.”
For instance, in Europe, he noted, the Official Medicines Control Laboratory helps with quality control.
“It is clear from this study, and others that have investigated various supplements, that the supplement industry suffers from a concerning 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, halostachine, or octopamine. The powder from the products 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, of which 13 listed R. vomitoria, 21 listed methylliberine, eight listed turkesterone, seven listed halostachine, and eight listed octopamine.
The authors noted that the sample size was small and they only analyzed one sample from each brand. Thus, their results may not apply to all products containing these botanical ingredients, and it’s possible that quantities of ingredients vary among batches of a product.