Quality Agreements with your Contract Manufacturer

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 first sentence states that the company that 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.

My associates and I hope you find these occasional updates helpful. If you would like to subscribe to our newsletter updates on foods, cosmetics, dietary supplements or over the counter drugs, simply reply to this post and let us know.

Contact us if you have questions or need help ensuring that your company is in compliance with FDA regulations.

Sincerely,

Evelyn & Associates

FDA Update on Importing Cosmetics

FDA recently updated the web page, “Information for Cosmetic Importers.”  This document uses a question and answer format and the update offers some clarification on the use of INCI (International Nomenclature Cosmetic Ingredient) names for cosmetic ingredients:

Is INCI nomenclature acceptable for identifying botanical ingredients?

INCI (International Nomenclature Cosmetic Ingredient) names for botanical ingredients typically use Latin names for genus and species to identify botanical ingredients. U.S. regulations require the use of common or usual names. Latin terms may be included parenthetically following the common or usual name of an ingredient. Example: Aloe (Aloe Barbadensis) Extract. See “FDA Response to CTFA Requests Regarding Harmonization of Ingredient Names (Color Additives, Denatured Alcohol, and Plant Extracts).”

It is very helpful to have this information spelled out by the agency since previously I and others have received conflicting information from the agency on the use of INCI names.

The related topic of C.I. numbers (used in European labeling) is also covered in the update:

Are C.I. numbers acceptable for identifying color additives on cosmetic labeling?

C.I. numbers are not acceptable on product labeling unless they are preceded by the color additive names accepted in the U.S. followed by the C.I. number in parentheses. In addition, C.I. numbers do not indicate FDA approval or FDA color certification. To learn more, see “Color Additives and Cosmetics” and the additional resources listed on that page.

Unfortunately, FDA has not been able to provide true clarity for what ingredients are and are not allowed in cosmetic ingredients.  The import update states that not all ingredients permitted use in cosmetics sold outside the US are permitted in the US and links to a very short list of prohibited ingredients.  But the update goes on to state, “But remember, any ingredient is prohibited if it causes the finished cosmetic product to be unsafe for consumers under labeled or customary conditions for use, even if there is no regulation specifically prohibiting or restricting its use in cosmetics.”  The associated link leads the reader to the brief list of prohibited ingredients and this Q&A:

Are these the only ingredients that can cause a product to become violative?

No. A product may become adulterated or misbranded in a number of ways. Among these are improperly used color additives or any ingredient, other than a coal-tar hair dye, that causes a cosmetic to be harmful under customary or usual conditions of use, or cause a cosmetic to become misbranded, as stated in the Federal Food, Drug, and Cosmetic Act, Sections 601 and 602. Additionally, an ingredient having a history of use in or as a cosmetic may at any time have its safety brought into question by new information.

So what is a cosmetic importer to do to determine whether an ingredient is permitted in the US?  Associates at Bioscience Translation &Application and FDALabels.com search various references and databases for safety information to provide guidance on levels of ingredients that are likely to be considered safe by FDA when reviewing cosmetic formulations for clients.  We are ready to help you with your questions about this or our other regulatory affairs services.

These blog pots are also sent as Informational emails to our subscribers.  If you would like to subscribe to our periodic updates on foods, dietary supplements or over the counter drugs, reply to this post.