The Food and Drug Administration recently posted a warning letter to American Pure Whey of Raleigh, NC, which makes a line of sports nutrition-positioned powdered protein products. The letter was predicated on the fact that the company had straddled the fence on whether one of its products was a food—a drink mix, essentially—or a dietary supplement.
“A review of the label for your American Pure Whey 100% Pure Whey Matrix Chocolate includes directions for use for the product ‘[a]s a dietary supplement.’ . . . If you intend to market this product as a dietary supplement, it must comply with the applicable statutory and regulatory requirements, including 21 CFR Part 111 and the nutrition labeling requirements under 21 CFR 101.36,” the warning letter reads.
Opening the GMP floodgates
The warning letter includes a slew of GMP violations that arose from the inspection of the company’s plant. These include a lack of written quality control procedures, lack of Master Manufacturing Records, lack of specifications, lack of process controls and so forth. There were a number of labeling violations mentioned, too, most prominently that the company used a Nutrition Facts panel on the back, and incorrectly called out some ingredients and ingredient amounts. All of these deficiencies flowed from the agency’s determination that the company was in fact manufacturing a dietary supplement, not a food. The letter does not delve into whether the company would have been considered to be in compliance with the regulations surrounding food manufacture but one thing is certain, dietary supplement GMPs set a higher compliance bar.
“That’s one thing that I always tell companies is that you have to be consistent in what you say about your product,” Justin Prochnow, a shareholder in the firm Greenberg Traurig, told NutraIngredients-USA.
While the question—supplement, or food?—is not new, Prochnow said the product matrix cited in this case is somewhat unusual.
“Usually this question goes more toward liquid products and FDA’s guidance about what makes a beverage and what makes a liquid dietary supplement. Whichever way you decide to go, you have to be consistent in what you say about it and how you label it. If you don’t, what that really does is give FDA the opportunity to pick which way they want to go with it, and they are always going to come down in the side of supplements, because the requirements of GMPs for supplements are a lot more stringent,” he said.
Protein shortfall
Another interesting aspect of the warning letter is that the agency specifically mentions that American Whey didn’t put as much protein into the product as it claimed it did. Prochnow said that he has not seen this kind of specific shortfall mentioned much on warning letters before.
“We’ve seen more of that from plaintiff’s lawyers than we actually have from FDA itself on that issue,” Prochnow said.
The issue of protein amounts has sparked controversy within the dietary supplements industry over the past several years as it became more widely known that formulators were using other ingredients besides protein—such as taurine or other amino acids—to ‘fool’ protein tests to give an inflated number. A long-used test for protein amounts looks for total nitrogen in a product. The confusion comes in because FDA regulations do not specifically mandate that the nitrogen found in these tests come from protein and only protein. The number of grams of protein contained in each serving has been a big selling point in the sports nutrition and active lifestyle categories. In 2014, the American Herbal Products Association, which has a Sports Nutrition committee, issued a guidance for members on the subject about how to conduct these tests so that there is a level playing field for protein products.
In the case of American Pure Whey, FDA said when it tested the product, it contained less protein than claimed on the label, though the specific amount of shortfall was redacted in the text of the warning letter. In another portion of the letter, the agency said that its inspector observed ingredients being added to the product that were not called out on the label itself. Those specific ingredients were also redacted from the letter. This leads to the possibility that American Pure Whey had been engaging in protein spiking, though Prochnow said there is no way to really know.
“There is not enough information to know. There really haven’t been a lot of warning letters about this, in part because the regulation isn’t specific,” Prochnow said.