It has been a while since we have sent any updates for our dietary supplement clients. The FDA has remained busy inspecting supplement companies and writing many, many warning letters. The regulations for dietary supplement Good Manufacturing Practices (GMPs) include a section on quality control requirements (21 CFR 111.103 – 111.40). Many dietary supplement distributors mistakenly think that quality control is the responsibility of their contract manufacturers. There have been a number of warning letters to companies who failed to have sufficient oversight or documentation of the system in place to ensure that their contract manufacturer was producing the product specified. A recent letter to Body Systems, Inc. of Winter Springs, FL delineates this responsibility and in addition states that failure to fulfill this responsibility can result I criminal liability:
“Although your firm may contract out certain dietary supplement manufacturing operations, it cannot, by the same token, contract out its ultimate responsibility to ensure that the dietary supplement it places into commerce (or causes to be placed into commerce) is not adulterated for failure to comply with dietary supplement CGMP requirements (see United States v. Dotterweich, 320 U.S. 277, 284 (1943) (explaining that an offense can be committed under the Act by anyone who has “a responsible share in the furtherance of the transaction which the statute outlaws”); United States v. Park, 421 U.S. 658, 672 (1975) (holding that criminal liability under the Act does not turn on awareness of wrongdoing, and that “agents vested with the responsibility, and power commensurate with that responsibility, to devise whatever measures are necessary to ensure compliance with the Act” can be held accountable for violations of the Act). In particular, the Act prohibits a person from introducing or delivering for introduction, or causing the delivery or introduction, into interstate commerce a dietary supplement that is adulterated under section 402(g) for failure to comply with dietary supplement CGMP requirements (see 21 U.S.C. §§ 342(g) and 331(a)). Thus, a firm that contracts with other firms to conduct certain dietary supplement manufacturing, packaging, and labeling operations for it is responsible for ensuring that the product is not adulterated for failure to comply with dietary supplement CGMP requirements, regardless of who actually performs the dietary supplement CGMP operations.”
An initial step for dietary supplement companies to take in order to address their responsibilities is to carefully write the contracts and agreements they have with their contract manufacturers. This week FDA issued a draft guidance document on quality agreements for the drug industry. While reading through it, I thought that many of the suggestions are relevant to the dietary supplement industry. The draft guidance discusses how both the ‘Owner’ of the product and the contract manufacturing facility are responsible for quality control and compliance with GMP regulations. The same is true in dietary supplement manufacturing. In the following excerpt from the draft guidance on quality agreements, think “dietary supplement” when you read “drug.” (Note that I have separated theses sentences for emphasis but they appear in a single paragraph in FDA’s document.)
“In all cases, the Owner is responsible for assuring that drugs introduced for interstate commerce are neither adulterated nor misbranded as a result of the actions of their selected Contracted Facilities.
All Contracted Facilities must assure compliance with applicable Current Good Manufacturing Practices for all manufacturing, testing or other support operations performed to make a drug(s) for the Owner.”
The second sentence states that the contract manufacturer must assure compliance with GMPs. While the first sentence states that the company will introduce the product into commerce, the “Owner” must take steps to ensure that the product has been properly manufactured. This requires auditing of the manufacturing process by the Owner to ensure that the manufacturer is fulfilling the contract. It may be helpful to read the full guidance here. At the very least, it can provide things to think about as you work with your contract manufacturer.