2013 warning letters: NDIs, beverage vs supplement, and brand holders' obligations among important themes

20-Dec-2013 - Last updated on 20-Dec-2013 at 18:14 GMT

Reading through the warning letter tea leaves, Denver-based attorney Justin Prochnow has come up with some important themes from the Food and Drug Administration. Obligations of brand holders, status of liquid products and the regulatory status of new ingredients were all featured in agency communication in 2013.

Some themes that can be gleaned from 2013’s warning letters are part of a constant drumbeat. Firms are cited by FDA for basic GMP violations and for making non-compliant disease claims on their products. But other themes, while perhaps not new per se, have acquired a renewed emphasis in the last year, Prochnow said, including the following:

Private label obligations

A warning letter from FDA to a company called Pristine Bay highlighted the responsibilities a private label brand holder has to ensure that its products are made correctly and in compliance with regulations, even if it doesn’t manufacture them itself.

“Your firm has an obligation to know what and how manufacturing activities are performed so that you can make decisions related to whether your dietary supplement products conform to established specifications and whether to approve and release the products for distribution,” FDA wrote.

“That was one of the first ones in 2013 that gave an indication FDA was going to go after private label distributors for potential manufacturing violations by their contract manufacturers,” Prochnow, a shareholder in the firm Greenberg Traurig, told NutraIngredients-USA. FDA officials have also stressed this theme in public presentations to industry stakeholders, most recently at the SupplySide West trade show in November in Las Vegas.

“Not just those manufacturers, but the people who hire those manufacturers are obligated to make sure those operations are in compliance,” Prochnow said.

Supplement or beverage?

Another warning letter, this one addressed to a company called Nature’s Health Options, outlines the agency’s thinking on the factors that separate a beverage from a liquid dietary supplement. Prochnow said the letter reiterates the point made in FDA’s draft guidance on the subject (which has languished for some years in draft mode), that what you say about the product, how your marketing messages position that product in the mind of the consumer, does carry weight with FDA in terms of how the agency will view the product. Few consumers would think of curling up in front of the fire with a cup of hot water and a tincture bottle. But if your marketing messages talk about the pleasures associated with drinking your tea, and you subsequently want to also call that product a dietary supplement, you could have a problem, Prochnow said.

In the case of Nature’s Health Options, the product in question was labeled as a supplement. “But all the statements about it—it was a great alternative to coffee or other teas, it was a great after-meal beverage—it goes back to the idea that if you label it as a supplement, you had better be consistent in talking about it as a supplement,” Prochnow said.

Is it a new ingredient, or is it a valid ingredient at all?

A couple of warning letters sent to companies in the sports nutrition category, an area of high concern for FDA, highlight the notion that FDA is looking carefully at the provenance of ingredients that might fall into the New Dietary Ingredient category, Prochnow said. A draft guidance on the subject is currently under review and possible revision by the agency, but that doesn’t mean that FDA isn’t enforcing its thinking on what the law means in the meantime, Prochonow said.

In a letter to a company called FormuLife, FDA warns that it “does not agree that dimethylamylamine (DMAA) is a dietary ingredient.” FDA said in the letter (as it has on numerous other occasions) that it does not believe that DMAA can be found in geranium. And even if it could, the agency said that there is no evidence it had ever been consumed as a dietry ingredient, meaning at the very least an NDI notification on the ingredient would have been necessary, Prochnow said.

The USPlabs letter (only the most recent warning letter that FDA has sent to that particular company) drives more directly at the point that the ingredient in question—aegeline—should have had a NDI notification on file in the agency’s opinion. There is not much argument here that the compound has a verifiable botanical origin in the tropical bael fruit. But had it been consumed before by man as a standalone ingredient? FDA said in the letter it is “aware of no history of use or other evidence of safety establishing that aegeline will reasonably be expected to be safe when used under the conditions recommended or suggested in the labeling of OxyElitePro and Versa-1.”

Marketers are always looking to find ways to differentiate their products from those of their competitors, and nowhere is this more true than in the booming sports nutrition space, where product cycles seem to be measured in months. But that quest for newness can come at a price, Prochnow said, and it behooves companies to think carefully about the risks a new ingredient might pose before tying up a lot of money in formulations and marketing materials.

“It just underlines the concept that a company has to make an initial analysis on whether the ingredients they are using are actually ingredients that meet the definition of what is a dietary ingredient. If it is a chemical or synthetic ingredient, it is more difficult to meet the definitions in DSHEA,” he said.