In a warning letter to New Horizons Nutraceuticals, the agency took the company to task over the marketing of its One World Whey Protein Power Food. The company, based in Kennett Square, PA, advertises the benefits of its whey protein, which it said is manufactured via a gentle, low-temperature process from milk sourced from “Amish cows.” According to the agency, the company was making the following illegal claims on the product:
- “Glutathione works to eliminate mercury, heavy metals, and virtually all toxins. It also neutralizes free radicals, thereby stopping cell damage and inflammation.”
- (testimonial) “I had been suffering from chronic pain…After 3 weeks on One World Whey, the pain in my feet reduced by 50%, and the overall pain in my body reduced significantly…the pain reduced significantly throughout my body…I’d highly recommend One World Whey to anyone dealing with chronic pain due to inflammation…”
In addition to the illegal disease claims, the warning letter cites the company for a plethora of GMP deficiencies. Along with numerous documentation shortcomings these included a failure to make a quality control decision when a lot of product was reworked to add additional ingredients. Another failure was the lack of documentation of the cleaning of equipment when a lot of product free of potential allergens was produced on a piece of equipment that had run an allergen-containing lot immediately prior. The company was also cited for irregularities in the way it labeled the product and called out the ingredients.
Heated subject of inflammation
Even if the product matrix here is unusual, attorney Justin Prochnow, a shareholder in the firm Greenberg Traurig, said using certain words together in a claim on a package or in marketing material on a website is almost guaranteed to get ears at FDA to perk up.
“Inflammation has been one of the topics of discussion over the past few years,” Prochnow told NutraIngredients-USA. “What really sets this one off is the addition of the word ‘chronic’ which is always going to get the agency’s attention.”
“With inflammation claims, when they are not tied to a specific non-disease form like inflammation from exercise, the FDA considers them to be disease claims. If you don’t say something like ‘post exercise inflammation’ the FDA will assume you’re talking about something like arthritis,” he said.
As noted above, the warning letter also took the company to task on the claims it was making about the detoxification potential of its product. Prochnow said this is more unusual, and probably would not have garnered a warning all on its own.
“I don’t believe that the FDA has sent warning letters based solely on detoxification claims. And I don’t think the company would have gotten a warning here on the detox claims if the inflammation mentions hadn’t been part of that,” he said.