FDA Establishes Manufacturing Requirements for Dietary Supplements (Part I - Foreign Firm Requirements, Etc.)

The FDA has also issued an interim final rule to allow an alternative to the final rule's required 100% identity testing provided certain conditions are met, etc.

Final Rule Compliance Date of June 25, 2008 or Later

Both the final rule and the interim final rule are effective August 24, 2007; however, the compliance date for both rules is June 25, 2008; except for businesses employing fewer than 500, but 20 or more full-time equivalent employees, for which the compliance date is June 25, 2009; and except for businesses that employ fewer than 20 full-time equivalent employees, for which the compliance date is June 25, 2010.

This is Part I of a multi-part series of summaries regarding these rules, and highlights the scope of CGMPs, the final rule's requirements for foreign exporters of dietary supplements, and the interim final rule's alternatives to the identity testing requirement established by the final rule. See future issues of ITT for additional summaries.

FDA Clarifies What CGMPs are to Achieve, Establishes Definition of Quality

FDA states that CGMPs are intended to establish a comprehensive system of process controls, including documentation of each stage of the manufacturing process, that can minimize the likelihood of, or detect, problems and variances in manufacturing as they occur and before the product is in its finished form.

To clarify what dietary supplement CGMP requirements are intended to achieve, the FDA has added a definition of quality in the final rule. As defined, quality means that the dietary supplement consistently meets the established specifications for identity, purity, strength, and composition and has been manufactured, packaged, labeled, and held under conditions to prevent adulteration.

Foreign Exporters/Suppliers of Dietary Supplements are Subject to Final Rule

The FDA states that this final rule applies to manufacturing, packaging, labeling, or holding a dietary supplement, including a dietary supplement imported or offered for import in any State or territory of the U.S., D.C., or the Commonwealth of Puerto Rico.

This means that foreign firms that export dietary supplements to the U.S. must satisfy the requirements of the final rule. According to the FDA, the foreign firms that will be most affected by the final rule are suppliers of dietary ingredients. (Although suppliers of dietary ingredients are not directly covered by the final rule, the need of manufacturers to meet the ingredient specifications required by the final rule will indirectly affect foreign suppliers, as well as domestic suppliers.)

Examples of the impact of this final rule on foreign firms include (partial list):

Availability of records, etc. Foreign firms who ship to the U.S. must operate under conditions that satisfy FDA regulations, including the requirement that records be made available during the course of an FDA inspection. The FDA notes that except in circumstances where there is a public health emergency or the FDA receives information that would indicate the appearance of adulteration of products shipped to the U.S., foreign inspections are generally scheduled weeks in advance.

According to the FDA, a foreign firm's refusal to allow the FDA to obtain records via an inspection for CGMP purposes (for the dietary supplements the foreign firm offers for import into the U.S.) would create the appearance that such imported dietary supplements are adulterated, and could lead to a refusal of admission.

Water quality. The final rule requires that water used in the manufacture of a dietary supplement in a manner such that the water may become a component of the dietary supplement, i.e., when such water contacts components, dietary supplements, or any contact surface, must, at a minimum, comply with applicable Federal, State, and local requirements and not contaminate the dietary supplement.

The FDA states that although certain Environmental Protection Agency water regulations would not apply to a foreign manufacturer, the foreign manufacturer would need to use water that is of a standard required in this final rule and that achieves the same level of performance required of domestic manufacturers. The water used by the foreign facility must not contaminate the dietary supplement that is manufactured.

FDA Interim Final Rule Establishes Alternatives to 100% Identity Testing, Etc.

FDA also states that it recognizes that it may be possible for a manufacturer to demonstrate, through various methods and processes in use over time for its particular operation, that a system of less than 100% identity testing would result in no material diminution of assurance of the identity of the dietary ingredient. Therefore, in its interim final rule, the FDA has added an exemption from the requirement of 100% identity testing when a manufacturer petitions FDA, and the FDA grants such exemption.

(FDA also includes a requirement in its interim final rule to ensure that the manufacturer keeps FDA's response to such a petition as a record under 21 CFR 111.95.)

(See ITT's Online Archives or 03/17/03 and 06/11/03 news, 03031720 and 03061120, for BP summary of the proposed rule to establish manufacturing and labeling standards for dietary supplements, and the extension of the comment period on the proposed rule, respectively.)

-Written or electronic comments on the interim final rule on identity testing must be submitted by September 24, 2007. Comments regarding its information collection must be submitted by July 25, 2007.

FDA contact - Vasilios Frankos (301) 436-1696

FDA final rule (D/N 1996N-0417 (formerly 96N-0417), FR Pub 06/25/07) available at http://a257.g.akamaitech.net/7/257/2422/01jan20071800/edocket.access.gpo.gov/2007/pdf/07-3039.pdf

FDA interim final rule (D/N 2007N-0186, FR Pub 06/25/07) available at http://a257.g.akamaitech.net/7/257/2422/01jan20071800/edocket.access.gpo.gov/2007/pdf/07-3038.pdf