Warning letter highlights importance of detailed quality agreements

By Hank Schultz

- Last updated on GMT

Related tags Dietary supplement

Warning letter highlights importance of detailed quality agreements
The importance of having a detailed quality agreement with your contract manufacturer has been driven home by a recent warning letter issued to a marketer of sports nutrition products.

It’s a common practice within the dietary supplement industry to use contract manufacturers and this is perhaps especially true in the sports nutrition sphere. Handling large volumes of powered ingredients requires special facilities, and many sports nutrition brand holders do not have as part of their business plans a goal to make the investment for dedicated manufacturing facilities. Many of these brands occupy smaller niches with smaller production runs, making it unlikely such an investment could be paid off in a reasonable time without in turn running those same lines in a contract manufacturing mode on the side.

Long standing view on ultimate responsibility

It’s entirely possible to operate a business based solely on contract manufacturing in a GMP-compliant manner, but care must be taken in specifying the relationship with that manufacturer and in making sure the ultimate responsibility continues to reside where it should properly lie.  As FDA put it in its warning letter to Rock Solid Nutrition, “Although your firm may contract out dietary supplement manufacturing operations, it cannot, by the same token, contract out its ultimate responsibility to ensure the dietary supplements it places into commerce (or causes to be placed into commerce) are not adulterated for failure to comply with dietary supplement CGMP requirements.” ​ Indeed, this view of who properly is responsible for what predates the founding in a regulatory sense of the dietary supplement industry; FDA bases this view on case law going back to 1943.

In the warning letter to Rock Solid Nutrition​, which is based in Omaha, NE, FDA dinged the company on a variety of GMP failures, most prominently for not having written procedures for its quality control managers.  The company makes a variety of sports nutrition supplements, including pre-workout products, whey protein isolate supplements and fat burners.

“Your written procedures for quality control operations must ensure that reserve samples are collected and held, all established specifications are met, master manufacturing records and batch production records are reviewed and approved, the dietary supplement is packaged and labeled as specified in the master manufacturing record, and returned dietary supplements are properly handled,”​ the agency wrote.

Importance of detailed quality agreement

Denver-based attorney Justin Prochnow, who is a shareholder in the firm Greenberg Traurig, said the letter emphasizes the importance of a having a detailed quality agreement with a contract manufacturer to go along with a general agreement that would cover pricing, delivery and so forth. Just telling FDA that your contract manufacturer handles the quality control on the supplements you sell in insufficient, he said.

“They will want to see a little more than that,”​ Prochnow told NutraIngredients-USA.

Prochnow said he’s sympathetic to the plight of smaller brand holders, but said that FDA has generally been inflexible on this point: If your name is on the bottle, the ultimate responsibility is yours. It’s similar to a sports team; the coach isn’t on the field, but the buck stops at his desk for what the team did, or didn’t do.

“The whole reason you hire a contract manufacturer is that you don’t have the requisite knowledge or facilities to carry out those manufacturing operations,”​ Prochnow said. “That does make it difficult, then, when FDA comes back and says you have the ultimate responsibility.”

Prochnow said a detailed quality agreement can alleviate some of these concerns.  Rather than saying, “my contract manufacturer is taking care of that” ​the firm can present that document to FDA to verify exactly how those quality procedures are being carried out.  

Final release into commerce 

Prochnow said that a brand holder must still have procedures in place to vet the quality of the finished goods that are delivered prior to their release into commerce.  Once again, in the case of some smaller manufacturers, it might be hard to justify having a full time person on staff if shipments might arrive only a few times a month.  Various consultants offer plug-and-play contract quality control services that could bridge this gap. But in any case the brand holder needs to have some sort of dedicated activity for that requirement, and needs to have a written procedure for how that requirement will be met.

“If the contract manufacturer is sending material back to the brand holder who will then distribute it, you need to have someone there who will review the documentation prior to release,” ​Prochnow said.

Labeling issues

FDA also took Rock Solid Nutrition to task on various labeling issues, including accurately accounting for portion sizes. For example, if the instruction on the label tells the customer to take “1 or 2” capsules per day, FDA assumes the single serving portion size to be two.

“Since our visit with the FDA we have taken all the steps necessary to ensure that the supplement information and directions on our labels are formatted and worded in a way that is compliant with the regulations,” said​ Rock Solid Nutrition owner Sean Loseke.

“Also, to ensure compliance with policies, we have written out all necessary procedures for quality control operations.  The FDA has been as pleasant as they could be about these issues and we have been able to apply what they have asked us to with no issues. We are grateful for the opportunity to learn and improve as our company grows,”​ Loseke said.

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