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Nowhere does FDA’s letter say the agency plans to change its existing GMP regulations for supplements at this time.
Back in May, State Attorney Generals (AG) wrote to FDA requesting that the agency overhaul its current Good Manufacturing Practices (GMP) regulations for dietary supplements in order to address “major flaws.” FDA has now answered-and the AGs might not like the response.
In May, New York State Attorney General Eric T. Schneiderman and State Attorney General Greg Zoeller of Indiana wrote to FDA stating a need to “drastically improve federal oversight of the dietary supplement industry.” In their letter, the AGs detailed their investigation of the dietary supplements industry earlier this year, a probe which they said confirmed “the serious quality control issues facing the industry.” The AGS went on to ask FDA to address four specific allegedly weak points in its dietary supplement GMPs.
Jeremy Sharp, FDA’s Deputy Commissioner of Policy, Planning, Legislation, and Analysis, wrote FDA’s response. His response is essentially a by-rote reiteration of the rules FDA already has in place pertaining to each of the AGs’ four points:
1. The AGs expressed concern that FDA’s current GMPs do not cover ingredient suppliers, “raising questions about the integrity of the dietary supplement supply chain.”
Sharp responded that supplement manufacturers are currently in charge of verifying the identity of ingredients and for working with suppliers to obtain certificates of analysis. In clear terms, he stated, “the burden is appropriately on manufacturers to ensure that the ingredients they use in their finished products meet these standards and to take steps to ensure the integrity of their suppliers.”
2. The AGs criticized FDA for only requiring that companies perform, at minimum, one identity test and stated that “the CGMP rules put flexibility ahead of quality and safety concerns, allowing manufacturers to set their own label specifications and then choose their own tests for confirming label claims.”
Sharp’s response echoes the current GMP regulation: “Manufacturers are responsible for identifying and using an appropriate scientifically valid method to ensure the identity of each component that is a dietary ingredient and for other testing to ensure specifications are met.” FDA can, he added, enforce against any misbranded label claims.
3. The AGs stated that “the CGMP rules do not require manufacturers to engage in any confirmatory testing to ensure that supplements are free of common allergens, even where products are marketed as containing no allergens (e.g., “Gluten-Free”).
Sharp stated that FDA’s Food Allergen Labeling and Consumer Protection Act (FALCPA) requires the agency to oversee the labeling for any ingredients FDA has defined as a “major food allergen.” Of gluten, Sharp wrote, “Gluten is not one of the major food allergens under FALCPA.” Instead, he pointed the AGs to the agency’s final rule on voluntary “gluten-free” labeling, which sets limits for the level of gluten in a product permitted to be labeled “gluten-free.”
4. The AGs said FDA’s GMP rules “fail to define the key terms applied to dietary supplements or require manufacturers to disclose to consumers how those terms apply to a given product.” Specifically, the AGs pointed to the term extract, which they said consumers might assume means a product is minimally processed when in actuality the product may be heavily chemically processed.
Sharp didn’t offer a detailed response for the term extract, but did say this about natural: “With respect to the specific terms you mention, “extract” and “natural,” FDA has under consideration citizens petitions submitted to FDA concerning the use of the term “natural” in food labeling. Currently, the term may not be used if the food contains added color, artificial flavors, or synthetic substances.”
Nowhere in Sharp’s letter does he say that FDA plans to change its existing GMP regulations for supplements at this time. Also, he wrote, “With respect to enforcement, please be assured that we have pursued inspections and actions on the Dietary Supplement GMPs and will continue to do so taking into account our resources and priorities based on risk.”
And he concluded thusly: “Thank you, again, for contacting us concerning this matter. We appreciate the efforts of your office to help protect consumers, and we look forward to working with you in the future. If you have any further questions or concerns, please let us know.”
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