FDA sent a warning letter to NYSW Beverage Brands, Inc. that detailed a number of GMP failures in the company’s operations and facilities. The letter also took the company to task for failing to make clear whether its products were conventional beverages or dietary supplements.
Regardless of what the company might say (or not say) on its labels, its has trouble right from the start with its very name, according to Marc Ullman, an attorney in the firm Ullman, Shapiro & Ullman who represents many food, supplement and beverage brands.
“If you look at your website, NYSW stands for New York Spring Water. That right there says you are promoting these products as conventional beverages. A supplement by definition is not a conventional food,” Ullman told NutraIngredients-USA.
Ingredient in caps
NYSW manufactures a line of waters that have various vitamin formulations contained within twist caps that are mixed into the beverage immediately before consumption. The formulas range from energy to general health and immune support, and include a variety of vitamins, minerals and other functional ingredients.
In the warning letter, FDA detailed a list of GMP failures that have mostly to do with documentation failures. According to FDA, the company lacked adequate quality control and failed to keep proper batch and master manufacturing records. The warning letter also asserts that the company failed to establish proper component specifications and failed to retain samples in a compliant manner.
According to Ullman, that adds up to the idea that if you intend to sell your products as dietary supplements, that entails more than merely saying “dietary supplement” on the label.
“What I found interesting about the warning letter is if you want to promote yourself as a dietary supplement, then you had better be compliant with CFR Part 111. That’s the gist of the warning letter. If you want to be a conventional food, then you have to be compliant with Part 110, and they are substantially different,” he said.
And as to the label, the company ran afoul of FDA by including a Supplement Facts panel on the back of the label, but failing to identify the products as a dietary supplement on the front. Jason Sapsin, an attorney in the firm Fox Rothschild, said FDA has said on a number of occasions that you can’t have it both ways. You can’t look to a consumer that you are beverage on the front and then tout dietary supplement attributes on the back.
“This is stuff that the agency has been saying consistently over a number of years. There is a guidance on the subject that goes through all of the factors that the agency would use to determine if the product is a supplement or a beverage, things like serving size and the use of words that might convey that it is a conventional beverage,” he said.
“When I work with when I work with beverage companies and liquid supplement companies there are some basic things that we go through when trying to decide how to position a product. Are there certain claims you want to make? How do you expect the product to be used by your consumers? Then they need to go back and look at the guidance.
“If you follow that three step process you should arrive at a place to make an informed decision on how you want to position the product including the labeling,” Sapsin said.