Sen McCaskill: “We shouldn’t be relying on Cohen et al to ensure industry is acting responsibly”

Methylsynephrine is also known as oxilofrine and p-hydroxyephedrine, and is not a legal dietary ingredient. The US Food and Drug Administration sent warning letters dated March 31, 2016​ to 7 companies regarding a total of 8 products marketed as dietary supplements and containing methylsynephrine as a dietary ingredient.

Data published this week in Drug Testing & Analysis​​ by a team of scientists from Harvard Medical School, Cambridge Health Alliance, the University of Mississippi, the Dutch National Institute for Public Health and the Environment, and NSF International indicated that, of the 27 products listing methylsynephrine on the label, 14 actually contained the ingredient. Doses ranged from 0.0003 to 75mg per individual serving.

If consumers followed the instructions on the label they could ingest 250mg of methylsynephrine per day, wrote the researchers, led by Dr Pieter Cohen. Typical prescription doses for oxilofrine range from 16 to 40mg for the stimulation of the heart and to increase blood pressure.

In a letter dated April 7 to FDA commissioner Robert Califf​, Sen McCaskill said that it was alarming that the Agency had taken so long to act.

“Tainted dietary supplements continue to reach American consumers—all because Congress and the FDA refuse to take even a small step towards responsible oversight to protect the American public,” ​she said in a press release. “For years, these dietary supplements have contained an ingredient that puts the public at risk of ill health effects and puts athletes in danger of being banned from competition. ​

“I am concerned that, once again, the FDA may have failed to act until they were faced with outside pressure. This team of researchers is doing tremendous work, but we should not be in a position of relying on them to ensure that this industry is acting responsibly.”​

“Preparing a Warning Letter takes time and resources”​

Sen McCaskill also expressed alarm that the FDA had only acted against three of the fourteen supplements listed in the Cohen paper. As we reported earlier this week, there are 25 products from seven brands containing “methylsynephrine” anywhere on the label listed in the Dietary Supplement Label Database​ (accessed April 5, 2016).  Only one of the companies listed on the DSLD received a warning letter from the FDA (Chaotic Labz).

Commenting on this discrepancy, Marianna Naum, PhD, strategic communications and public engagement staff in the Office of Foods and Veterinary Medicine at the FDA, told us: “FDA’s action provides regulated industry with a clear message regarding the status of methyl synephrine:  no firm can now remain under the illusion that methyl synephrine is a dietary ingredient.  Preparing a Warning Letter takes time and resources, and products frequently come on and off the market, so the agency works hard to strike the right balance. If FDA waited to act until we were certain we had addressed every marketed product, we wouldn’t ever be able to issue these warning letters.”​

Sen McCaskill and supplements​

Sen. McCaskill has become increasingly vocal against the presence of “fraudulent or unsafe dietary supplements”​ in the marketplace.

She opened an inquiry into brain health supplements​ last summer by sending letters to the FDA and 15 major retailers after launching an inquiry into products, regulations, and retailers in the dietary supplement industry that specifically market to seniors using claims about improving memory and treating dementia and Alzheimer’s disease.

She also called on the FDA to suspend sales of supplements containing vinpocetine and picamilon​ pending an investigation. When the Agency was perceived to not be acting quickly enough, Sen McCaskill wrote to the 10 retailers to ask them to voluntarily remove any picamilon supplements​.

Last week she requested a comprehensive list of enforcement actions​ taken by the Department of Justice related to the dietary supplement industry.