A new warning letter illustrates FDA’s stance on the obligations of private label distributors to ‘ensure that all phases of the production of [a] product are in compliance with dietary supplement CGMP requirements’.
The American Herbal Products Association (AHPA) said: “Companies that use contract manufacturers, packagers, or labelers should read this letter”.
In the warning letter, dated April 26, 2013, FDA writes: “As a distributor that contracts with other manufacturers to manufacture, package or label dietary supplements that your firm releases for distribution under your firm’s name, 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 [72 Fed. Reg. 34752, 34790 (June 25, 2007)].
“Your firm introduces or delivers, or causes the introduction or delivery, of dietary supplement products into interstate commerce in their final form for distribution to consumers.
“As such, your firm has an overarching and ultimate responsibility to ensure that all phases of the production of that product are in compliance with dietary supplement CGMP requirements.”
The obligations of private label distributors
In his weekly Lawguy’s Corner blog, Justin J. Prochnow, shareholder at lawfirm Greenberg Traurig, LLP in Denver, said: “I have previously identified warning letters in which FDA has reiterated the obligations of private label distributors to ensure that the cGMPs are followed, even if the private label distributors do not perform any manufacturing duties.
“While other letters have pointed out the obligations of private label distributors, FDA, in an April 26, 2013 letter to Pristine Bay LLC dba Vianda, goes to greater lengths to emphasize the private label distributors’ obligations.”
If you use a contract manufacturer, read this letter
“FDA has for some time taken the position that companies using contract manufacturers have substantial cGMP responsibilities,” stated AHPA in a legal alert. “To support this proposition, FDA cites from the preamble to the cGMP regulations.
“In this warning letter, FDA goes further and cites the strict criminal liability nature of violations of the Federal Food, Drug, and Cosmetic Act. Companies that use contract manufacturers, packagers, or labelers should read this letter.”
The firm that contracts with other firms […] is responsible […] regardless of who actually performs the dietary supplement CGMP operations
Prochnow identified key passages from the warning letter to note: “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 supplements it places into commerce (or causes to be placed into commerce) are not adulterated for failure to comply with dietary supplement CGMP requirements.”
FDA then recommended the company to see United States v. Dotterweich, 320 U.S. 277, 284 (1983), which explains 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”.
The Agency also points the company to United States v. Park, 421 U.S. 658, 672 (1975), which holds 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.
The warning letter continues: “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), 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 dietary supplement is not adulterated for failure to comply with dietary supplement CGMP requirements, regardless of who actually performs the dietary supplement CGMP operations.”
“There is no question that FDA has been and is going to continue to conduct inspections with a particular focus on the principles set forth above,” said Prochnow.
“Dr. Daniel Fabricant reinforced this at Supply Side Marketplace, indicating that the assurance of strict compliance with the dietary supplement cGMPs continues to be a very high priority issue for FDA.”