Despite some retailers complaining about the MHRA (Medicines and Healthcare products Regulatory Agency) Borderline Team specifically targeting products like Jack3D, the MHRA said it had only sent four letters to UK retailers.
These related to two separate DMAA products – USP Labs manufactured OxyElite Pro and Ergopharm Ergolean AMP, but not Jack3D, also made by USP Labs.
An MHRA spokesperson said: “The MHRA has to make decisions on a case-by-case basis, so we are not able to say that all DMAA products will be medicines.“
“MHRA issued notices to four retailers to remove products - two of whom were selling OxyElite Pro and two were selling Ergopharm Ergolean AMP.”
The agency said it had not had any contact with USP Labs as it was not a UK-based enterprise.
It has not as yet clarified the grounds upon which it was taking action against DMAA-containing products, typically used for pre-gym workout and weight loss.
One retailer that had been contacted by the MHRA – Predator Nutrition – had altered its portfolio to remove any mention of DMAA, along with products containing it like Jack3D and OxeElite Pro.
But it continued to market products labelled with the disputed DMAA source – the geranium plant.
While that plays out, it is not only DMAA products that have been targeted by the agency. Manufacturers and retailers of products containing the likes of black cohosh, yohimbe, valerian, milk thistle, horny goat weed, hoodia, GABA, DHEA, synephrine and more have been contacted.
Cheryl Thallon, the founder of €3m, 11-year-old UK supplements manufacturer, Viridian, said her company was one of many trading in black cohosh products that had received MHRA letters in December last year, primarily concerned with product dosage issues.
“We answered all the questions raised in the 21 day period given in the letter and have not heard back from the agency since,” Thallon said.
Duel route to market
While backing MHRA enforcement of the law, she said it was important to recognise there were two official avenues to market for food and herbal supplements – under food law and medicines law including the EU Traditional Herbal Medicinal Product Directive (THMPD) whose seven-year transition period expired in April last year.
Viridian has no THMPD registrations and is content to market its products as food supplements, typically without health claims.
“We comply with the regulations but the THMPD is confusing, expensive and badly written. And it is important to note there are duel routes to market – food supplements and those that are deemed medicinal. We have no intention of going down the THMPD route.”