CRN asks FDA to rethink 'chemically altered'

FDA should examine not just the manufacturing process to determine what is chemically altered, but compare the starting and ending substances with an eye to whether those changes affected the safety of the end product.

The Council for Responsible Nutrition (CRN), the dietary supplement industry’s leading trade association, provided its fifth substantive submission to FDA in response to the agency’s New Dietary Ingredient (NDI) Draft Guidance, this time through comments submitted by international law firm Steptoe & Johnson LLP. This document specifically addresses when an ingredient is chemically altered such that it would require a separate NDI notification to FDA.

On behalf of CRN, the Steptoe & Johnson comments call on the agency to “take into account not only whether the chemical structure of the dietary ingredient has been changed, but also whether any change in structure is sufficiently significant to potentially cause dietary supplements containing the dietary ingredient to be unsafe for consumers.” In other words, FDA should examine not just the manufacturing process to determine what is chemically altered, but compare the starting and ending substances with an eye to whether those changes affected the safety of the end product.

The comments also urge FDA to consider the efficiency and effectiveness to be gained were the agency to focus on the chemical identity and safety of the dietary ingredient, as opposed to establishing an exhaustive list of manufacturing processes that do not chemically alter a dietary ingredient. Further, the comments suggest FDA look favorably to its own precedent in how it has previously approached the “chemically altered” definition as a model for NDIs which focuses on whether the change in the method of production alters the chemical structure of the dietary ingredient in a way which has the potential be significant for its safety. That standard of evaluation for chemical changes should be equally applicable under DSHEA as compared to other FDA-regulated food products.
FDA’s overly restrictive interpretation in its NDI Draft Guidance of the term “chemically altered” represents one of several issues CRN has previously identified within the Draft Guidance as problematic; however, the “chemically altered” issue is one which CRN believes would greatly—and unfairly—expand the category of ingredients that would constitute an NDI, thereby inappropriately placing unnecessary and burdensome requirements on the industry.

In the comments, Steptoe & Johnson also maintained, “The key factor in the FDA guidance with respect to all of these types of food and food-contact substances is that a submission to FDA is recommended only for manufacturing changes which alter the chemical structure of a product in a way which has the potential to create an issue concerning the safety of the product for its intended conditions of use. This precedent supports the proposition that ‘chemically altered’ under DSHEA should not be defined by a list of processing methods.”

These comments mark the fifth formal submission by CRN in response to FDA’s NDI Draft Guidance since the draft guidance was released in December 2011. CRN first submitted substantial comments on December 2, 2011, during the initial FDA comment period. CRN later twice called on FDA to reverse its position that synthetic constituents of botanicals cannot be dietary ingredients in October 2012 and December 2012 letters to FDA Commissioner Margaret Hamburg, M.D. Last week, CRN sent a letter to the docket in support of comments submitted by the American Herbal Products Association requesting FDA issue revised guidance with a specific focus on information to be included in an NDI notification to identify the new dietary ingredient.

According to CRN’s Duffy MacKay, N.D., vice president, scientific & regulatory affairs, “This guidance is a very important one for our industry, and we are working hard to help ensure the agency hears the concerns of industry, and that it will respond with a more reasonable final guidance.”

In submitting its most recent comments, CRN sought counsel from Ralph A. Simmons, a partner in the Washington office of Steptoe & Johnson, LLP and a former senior policy analyst in the Office of Food Additive Safety, Center for Food Safety and Applied Nutrition, FDA. At FDA, Mr. Simmons served as a senior advisor to the acting director of the Office of Food Additive Safety, with respect to FDA’s regulation of direct food additives, and generally recognized as safe (GRAS) substances. Additionally, he helped develop FDA’s 2012 Draft Guidance for [the Food]Industry: Assessing the Effects of Significant Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients that Are Color Additives, the FDA’s standard that CRN references in its comments.


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