February 18, 2014
FDA PRA Staff
Office of Operations, Food and Drug Administration
1350 Piccard Drive, PI50-400B
Rockville, MD 20850
Re: FDA-2013-N-1619 (Comment Request; Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements)
Dear Sir or Madam:
The Academy of Nutrition and Dietetics (the "Academy") is pleased to comment on the proposed information collection regarding Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements published in the Federal Register December 19, 2013. The Academy is the world's largest organization of food and nutrition professionals, with more than 75,000 members comprised of registered dietitian nutritionists (RDNs),1 dietetic technicians, registered (DTRs), and advanced-degree nutritionists. Every day we work with Americans in all walks of life — from prenatal care through end of life care — providing nutrition care services and conducting nutrition research. We are committed to evidence-based strategies for improving the nation's health through food and nutrition.
The Academy supports the proposed information collection and believes it is necessary for the proper performance of the Food and Drug Administration's (FDA's) functions.
The FDA helps prevent and identify any adulteration of dietary supplements in part by appropriately promulgating, by regulation, good manufacturing practices pursuant to section 402(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342(g)). Americans who purchase dietary supplements to address a nutritional deficiency or for other purposes should be able to have confidence in the quality and verifiability of the supplements they consume. The Academy believes the reasonable, minimally burdensome record-keeping requirements detailed in this information collection will provide consumers with the necessary assurance that FDA is able to identify and recall any adulterated or otherwise mislabeled products.
The Academy agrees with the FDA that "[r]ecords are an indispensable component of CGMP" and that they "provide the foundation for the planning, control, and improvement processes that constitute a quality control system." As the FDA notes,
[R]ecords show what is to be manufactured; what was, in fact, manufactured; and whether the controls that the manufacturer put in place to ensure the identity, purity, strength, and composition and limits on contaminants and to prevent adulteration were effective. Further, records will show whether and what deviations from control processes occurred, facilitate evaluation and corrective action concerning these deviations (including, where necessary, whether associated batches of product should be recalled from the marketplace), and enable a manufacturer to assure that the corrective action was effective. In addition, by establishing record-keeping requirements, FDA can ensure that industry follows CGMP during manufacturing, packaging, labeling, or holding operations.
The Academy recognizes and appreciates the FDA's vigilance in identifying and notifying the public about adulterated foods and dietary supplements recalled for undeclared ingredients and the presence of certain ingredients that change the classification of products from dietary supplements to unapproved drugs.2 Recent news stories report that "DNA tests show that many pills labeled as healing herbs are little more than powdered rice and weeds"3 and studies show high doses of toxic metals such as lead, arsenic, and mercury were present in over twenty percent (20%) of randomly tested Ayurvedic herbal medications.4 This proposed information collection will ensure manufacturers maintain and retain records demonstrating their compliance with CGMP.
The Academy appreciates the opportunity to comment on the proposed information collection and offers our assistance with your continued efforts to ensure safety, quality, and transparency in the manufacture of dietary supplements. Please contact either Jeanne Blankenship or Pepin Tuma with any questions or requests for additional information.
Jeanne Blankenship, MS RDN
Vice President, Policy Initiatives and Advocacy
Pepin Andrew Tuma, Esq.
Director, Regulatory Affairs
1 The Academy recently approved the optional use of the credential "registered dietitian nutritionist (RDN)" by "registered dietitians (RDs)" to more accurately convey who they are and what they do as the nation's food and nutrition experts. The RD and RDN credentials have identical meanings and legal trademark definitions.
2 See, Food and Drug Administration website, "Recalls, Market Withdrawals, & Safety Alerts," available at
http://www.fda.gov/safety/recalls/ (accessed February 14, 2014)
3 Anahad O'Connor, Herbal Supplements Are Often Not What They Seem, New York Times, November 3, 2013, available at http://www.nytimes.com/2013/11/05/science/herbal-supplements-are-often-not-what-they-seem.html?pagewanted=all&_r=1&
4 See, e.g., Saper RB, Phillips RS, Sehgal A, et al. Lead, Mercury, and Arsenic in US- and Indian-Manufactured Ayurvedic Medicines Sold via the Internet. JAMA. 2008;300(8):915-923. doi:10.1001/jama.300.8.915; Saper RB, Kales SN, Paquin J, et al. Heavy Metal Content of Ayurvedic Herbal Medicine Products. JAMA. 2004;292(23):2868-2873. doi:10.1001/jama.292.23.2868.