FDA Extends Comment Period on Alternative to 100% Identity Testing of Dietary Ingredients in Supplements
The Food and Drug Administration has issued a notice which extends the comment period on its August 24, 2007 interim final rule that established an alternative to its requirement of 100% identity testing of dietary ingredients in supplements1.
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FDA states that it is extending the comment period to October 24, 2007 (from September 24) in response to requests to allow additional time to submit comments.
(On August 24, 2007 the FDA implemented a final rule and this interim final rule with a compliance date of June 25, 2008 or later, depending on business size. The final rule established current good manufacturing practices (CGMPs) for dietary supplements which, among other things, required 100% identity testing of components that are dietary ingredients. The interim final rule set forth a petition procedure to request an exemption from the 100% identity testing requirement through use of alternative record retention requirements.)
Alternative to 100% Identity Testing of Dietary Ingredients in Supplements
In its interim final rule, the FDA stated 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.
The interim final rule, therefore, amended 21 CFR 111.75(a)(1)(ii) to allow the submission of a petition that sets forth the scientific rationale, and is accompanied by supporting data and information, for the proposed alternative testing method. The proposed alternative must demonstrate that there is no material diminution of assurance, compared to the assurance provided by 100% identity testing, of the identity of the dietary ingredient before use, when the dietary ingredient is obtained from one or more suppliers identified in the petition.
(If the FDA grants the petition, the tests and examinations for the dietary ingredient otherwise required under 21 CFR 111.75(a)(1)(i) must be conducted under the terms specified by the FDA. (Note certain records must be retained.)
1FDA states that it did not include the exemption procedure in the CGMP final rule because it wanted to provide an opportunity for interested persons to comment on whether the exemption procedure should be modified, and if so, whether there is any additional information that may be helpful to articulate with respect to what a petition needs to show that may inform future guidance.
(See ITT's Online Archives or 07/20/07 and 07/23/07 news, 07072015 and 07072307, for Parts I-II of BP's summary of the interim final rule and final rule, respectively.)
FDA contact - Vasilios Frankos (301) 436-1696
FDA extension notice (D/N 2007N-0186, FR Pub 09/17/07) available at http://a257.g.akamaitech.net/7/257/2422/01jan20071800/edocket.access.gpo.gov/2007/pdf/E7-18293.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