FDA Establishes Specific Manufacturing Requirements for Dietary Supplements (Part II - Final - Highlights)

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.

(Note that the FDA received approximately 400 comments in response to the proposed rule, all of which are discussed in the preamble to the regulatory text of the final rule.)

Rules Effective August 24, 2007, 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 II, the final partof a multi-part series of summaries regarding these rules, and highlights various requirements established by the final rule, including requirements for personnel, manufacturing plants, equipment, control processes, etc. (See ITT's Online Archives or 07/20/07 news, 07072015, for Part I on requirements for foreign firms, etc.)

Final Rule Establishes Requirements for Personnel, Manufacturing Plants, Etc.

According to the FDA, highlights of the new CGMPs for dietary supplements include (partial list):

Applies to persons who manufacture, package, label, or hold dietary supplements unless subject to exclusion in 21 CFR 111.1;

Establishes minimum requirements for personnel, physical plant and grounds, and equipment and utensils;

Requires the establishment and use of written procedures for certain operations, including those related to equipment, physical plant sanitation, certain manufacturing operations, quality control, laboratory testing, packaging and labeling, and product complaints;

Requires the establishment of specifications in the production and process control system that will ensure dietary supplements meet the identity, purity, strength, and composition established in specifications and are properly packaged and labeled as specified in the master manufacturing record;

Provides for the option to use a certificate of analysis (for specifications other than the identity of a dietary ingredient) from a component supplier instead of having manufacturers conduct tests or examinations on the components they receive;

Requires testing of a subset of finished batches of dietary supplements based on a sound statistical sampling or, alternatively, testing all finished batches;

Requires implementation of quality control operations to ensure the quality of a dietary supplement;

Requires the preparation and use of a written master manufacturing record for each unique formulation of manufactured dietary supplement, and for each batch size, to ensure the manufacturing process is performed consistently and to ensure uniformity in the finished batch from batch to batch;

Requires the preparation of a batch production record every time a dietary supplement batch is made. The batch production record must accurately follow the appropriate master manufacturing record;

Requires the establishment and use of laboratory control processes related to establishing specifications and to the selection and use of testing and examination methods;

Requires reserve samples of dietary supplements to be held in a manner that protects against contamination and deterioration;

Requires identification and quarantine of returned dietary supplements until quality control personnel conduct a material review and make a disposition decision;

Requires quality control personnel to conduct a material review and make a disposition decision under certain circumstances;

Requires a qualified person to investigate any "product complaint" that involves a possible failure of a dietary supplement to meet any CGMP requirement, with oversight by quality control personnel; and

Requires records associated with the manufacture, packaging, labeling, or holding of a dietary supplement to be kept for 1 year beyond the shelf life dating (when such dating is used, such as expiration dating, shelf life dating, or "best if used by" dating), or if shelf life dating is not used, for 2 years beyond the date of distribution of the last batch of dietary supplements associated with those records.

Dietary Supplement CGMPs are in Addition to General Food CGMPs

According to FDA, the general food CGMPs in 21 CFR Part 110, which also apply to dietary supplements, largely address practices designed to ensure that food is manufactured, processed, packed and held under sanitary conditions, and that the food is safe, clean, and wholesome.

However, these general food CGMPs do not address the unique characteristics of certain specific types of food products. As a result, FDA has implemented separate, and more specific, CGMPs for various types of food products to provide for process controls in manufacturing that are not captured by the more general Part 110 food CGMPs.

With these final and interim rules, there will now be five of these additional, specific food CGMP regulations - for infant formula, thermally processed low-acid canned food, acidified food, bottled water, and dietary supplements.

(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 must be submitted by September 24, 2007. Comments regarding 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