Industry Groups Take Lead In Outing Drug Disguised As Dietary Supplement
This article was originally published in The Rose Sheet
Executive Summary
Four groups say drug identified as “phenibut” is being used in products fraudulently labeled as supplements. The drug, reportedly developed in the former Soviet Union for brain-enhancing properties, has been found in products typically marketed for cognitive benefit and mood enhancement."We're not going to wait for someone to tell us this is not a dietary ingredient," says CRN executive Duffy MacKay.
Dietary supplement industry trade groups aren't waiting for FDA to identify the latest drug disguised as a dietary ingredient to reach the US and potentially give compliant manufacturers another black eye.
Four groups on Nov. 5 said a drug identified as “phenibut” is being used in products fraudulently labeled as supplements. The drug, which reportedly was developed in the former Soviet Union for brain-enhancing properties, is not identified on labels but has been found in products typically marketed for cognitive benefit and mood enhancement.
"We're not going to wait for someone to tell us this is not a dietary ingredient," said Duffy MacKay, the Council for Responsible Nutrition's senior vice president for scientific and regulatory affairs. "We're fed up with illegitimate ingredients trying to masquerade in dietary supplements," MacKay said in an interview.
CRN and other trade groups – American Herbal Products Association, Consumer Healthcare Products Association and United Natural Products Alliance – recently became aware of phenibut sales in the US when addiction treatment groups reported that the drug was being marketed in bulk, labeled as a dietary ingredient. The trade groups found phenibut also is available in dietary supplement pills, capsules and powders.
"An extra red flag came up for us," MacKay said about the addiction treatment groups' findings. "There is some information out there that would lead one to believe that the mechanism of this substance has some central nervous system action and that it does have some additive potential," he said.
The groups advised FDA about their concerns and also warned manufacturers, marketers and retailers to halt production, sale or promotion and consumers to stop consumption of the substance. FDA didn't indicate whether it will act on the information and investigate sales of products labeled as supplements but containing phenibut, MacKay said.
If FDA conducts enforcement to rid the market of phenibut-containing supplements, "we are going to be able say we are in total agreement," he said. "We know regulators have limited resources and we know that FDA has to take everything on a case-by-case basis and make their own determination."
'Shady Companies' Need Not Apply
The trade groups have not identified or contacted any business marketing phenibut-containing supplements other than to know that it is not one of their members. As with other ingredients purported to be dietary but determined to be pharmaceutical, trade group members aren't likely to use phenibut.
"These are not the people we work with. This is the illegal industry that's trying to kind of hijack our reputation," MacKay said.
Neither are the violative products listed on CRN's Supplement Online Wellness Library, an industry-wide, self-regulatory initiative to provide a robust and complete picture of the supplement marketplace for regulators, retailers and industry stakeholders. (Also see "Health, Beauty And Wellness News: Nestle Compleat, FDA Nutrition Strategy" - HBW Insight, 27 Jun, 2018.)
"It is somewhat of a deterrent to shady companies. They don't appear to be interested in registering with the OWL," MacKay said.
The US industry's previous experiences with substances similar to phenibut drugs have played out with FDA using warning letters to clear the market before some of the warned firms launched prolonged court battles arguing that a challenged ingredient was dietary and their products were complaint. (Also see "SARMs Spells Latest 'Synthetic Steroids' FDA Finds In Supplements" - HBW Insight, 31 Oct, 2017.) Those conflicts also have prompted members of Congress to suggest that FDA shave have some pre-market approval oversight of the supplement industry to prevent drug-spiked products from reaching the market. (Also see "Senators Push Park Doctrine Prosecution For Spiked Supplement ‘Criminal Endeavors’" - Pink Sheet, 20 May, 2015.)
This experience, though, could play out allowing phenibut supplement marketers no room to argue.
"We're going to give them visibility as not dietary ingredients," MacKay said.