Warning letter provides insight into labeling responsibilities

By Hank Schultz contact

- Last updated on GMT

Warning letter provides insight into labeling responsibilities
A warning letter to a company called Rocky Fork Formulas has particular insights for the labeling operations in the dietary supplement responsibility chain.

FDA recently posted the letter it sent to Rocky Fork​, based in Westerville, Ohio.  The letter, dated May 13, includes citations on disease claims, manufacturing considerations and labeling violations. 

Disease claim violations

On the disease claim front FDA takes the company to task for a wide variety of impermissible disease claims, none of which will come as great surprises to industry observers.  According to FDA, Rocky Fork was making a variety of claims on its products on its websites that included “These oils have been cited in numerous studies as being an important factor in preventing heart and coronary disease”​ for a product containing EPA;  a product called Gluco Poise that the websites said was “is a unique and powerful tool for use in controlling blood sugar.”​ And in describing a timed-release niacin product the company said it “lowers cholesterol…and has also been used to alleviate joint pain.” ​ In addition, FDA opined that the use of the word “arthritis” ​in the name of a product constituted a disease claim in and of itself.

It is the portion of the letter that talks about Rocky Fork’s relationship to its contract manufacturers that holds the most interest for the dietary supplement industry.  FDA’s position has long been that brand holders cannot contract away their responsibility for ensuring that products are properly manufactured in compliance with GMP rules. Rocky Fork occupies a different sort of niche, filling orders from healthcare professionals such as MDs, naturopaths, chiropractors and others for products with the Rocky Fork labels on them. It’s an unusual niche, but that doesn’t change Rocky Fork’s burden of responsibility.

“I think that’s why you don’t see the language in the warning letter you usually see about private label distributors, and this is mostly directed at their packaging and labeling operations,”​  attorney Justin Prochnow told NutraIngredients-USA. Prochnow is a shareholder in the firm Greenberg Traurig who counts many dietary supplement companies among his clients.

No intake procedure for contract manufacturers

FDA cites Rocky Fork for a number of deficiencies in its relationship with its contract manufacturers. According to the warning letter, the company was unable to produce any product specifications at the time of the inspection and did not attach any in its response letter to FDA on the observations noted in the inspection. Additionally, FDA asserted that Rocky Fork had no procedure to verify that the goods received from contract manufacturers met contract spec.

FDA said the company had no quality control procedures for the proper labeling and holding of the dietary supplements it distributes. The agency also cited the absences of a process for receiving complaints and for holding samples of products that had been distributed. In all of these citations, FDA said that the company’s response letter did not contain enough detail to evaluate how it intended to address the inspection observations.

Prochnow said that while a practitioner distributing one of these products could potentially bear some responsibility for these kinds of concerns, it is Rocky Fork’s responsibility to be able to prove that it knows that its contract manufacturers are putting the right things into the bottles and that after it receives goods from its contract manufacturers that it is putting the right labels on the right bottles.

“You are going to get cited if you don’t have SOPs to ensure that you are getting the right things from your contractors. A lot of this could be spelled out in a good quality agreement with your contract manufacturer,” ​he said. Without that, Prochnow said FDA is bound to ask for evidence that a company knows what it is sending into the marketplace, evidence which according to the warning letter Rocky Fork was unable to supply.

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