Warning letter shows FDA still enforcing status quo on CBD
The US Food and Drug Administration posted a warning letter last week that was sent to Alternative Laboratories, also known as Alternative Labs, a company based in Naples, FL. The company's website indicates it is a contract manufacturer with capabilities of manufacturing liquids, powders and capsules.
According to the warning letter, Alternative Labs markets a variety of functional beverages which include enhanced coffees and cocoa drinks.
Letter focused on use of DMHA, CBD
The warning letter maintains that the company had included the ingredient DHMA in the beverages. Based on the warning letter, Alternative Labs was calling this out on labels as 2-amino-5 methylheptane or Octadrine. But according to FDA the compound goes by other names, including 1,5-DMHA, 2-amino-6-methylheptane, 2-aminoisoheptane, 1,5-Dimethylhexylamine, 6- Amino-2-methylheptane, Amidrine, 2-Metil-6-amino-eptano, and 2-Isooctyl amine.
DHMA has been one of the ingredients that sports formulators have turned to in the wake of ephedra being taken off the market. The first go round focused on DMAA, which was taken off the market because of safety concerns, including its association with the deaths of two military personnel.
DMHA came in the second wave of stimulant-like ingredients, a wave than included ingredients like Dendrobium and BMPEA.
Wave of DMHA warning letters
Earlier this year FDA issued a number of warning letters based on the inclusion DMHA in products marketed as dietary supplements. According to a review paper published in the journal Brain Science, DMHA was originally developed as nasal decongestant drug but has not been on the market for many decades. It was revived in recent years by formulators seeking new stimulant like ingredients in the wake of ephedra and DMAA vanishing from the market.
In the Alternative Labs warning letter, FDA states that the ingredient in unlikely to meet the definition of a dietary ingredient in the first place. And if it did, it does not qualify for Old Dietary Ingredients status, nor is there an NDI Notification on file for the ingredient.
In a subsidiary portion of the letter, FDA notes that Alternative Labs is marketing a CBD oil product. It makes the same observations about CBD as it did about DHMA. In both cases the supplements containing DHMA and CBD were classified in the letter as adulterated.
Senate Majority leader Sen. Mitch McConnell, D-KY, has moved to require FDA to issue a formal enforcement discretion policy on CBD within the next couple of months while the agency works out a formal regulatory paradigm for the ingredient. In the meantime, though, it’s caveat emptor for any formulator working with the ingredient. FDA does not seem to be out there looking for CBD cases, but when one comes over the transom, it will enforce based on its current reading of the law.
“Once something triggers FDA’s decision to issue a Warning Letter, in this case it seems it was DMHA, it will often include additional observations that may not themselves have triggered a Warning Letter. Perhaps FDA does so in order not to be seen as condoning them by silence, perhaps it is for other reasons. We of course do not know, but that may have been the case here,” attorney Ivan Wasserman told NutraIngredients-USA. Wasserman is a partner in the firm Amin Talati Wasserman which represents many dietary supplement companies.
Alternative Labs CEO responds
Alternative Labs CEO Kevin Thomas noted that the inspection that FDA conducted and on which the warning letter was based found no serious issues with the company’s GMP compliance. And he said the company recently received a clean audit from NSF as well. In addition, he claimed the company had preemptively stopped manufacturing the products in question.
"In regards to the Warning Letter, the agency directs it comments mainly towards DMHA and we are in the process of responding to the agency and it would not be appropriate to preview our response in the press as the agency, in a spirit of cooperation, agreed to give us to October 30th to respond. With that said, we had already discontinued the manufacturing of DMHA products prior to the warning letter even though we believe the ingredient is eligible to be a dietary ingredient and is reasonably expected to be safe. Indeed, we fully support the FDA and embrace their efforts to ensure compliance and will continue to strive to do so as we move forward with our future discussions with FDA regarding DMHA. In the meantime, we continue to believe that the path forward is better done in cooperation with FDA and not as an adversary," he said.
"The warning letter also referenced that CBD is not an eligible dietary ingredient. However, in the past, FDA has exercised its enforcement discretion in only issuing warning letters to companies make aggressive disease claims, which our customer did not make. Indeed, we are the first to receive one unrelated to claims. However, importantly, the letter did not request that we stop manufacturing the product even though it made such a request in relation to DMHA. We, however, plan to fully address the agency’s preclusion arguments in our warning letter response as we believe, like the more than 1700 different brands of CBD, CBD is not precluded from being marketed as a dietary or food ingredient. In this regard, we support the agency’s decision to align its path forward with CBD with the public’s desire to have access to it and plan to be an active participant in this process," Thomas added.