12.02.11
The nonprofit organization American Botanical Council (ABC) has filed public comments with FDA in response to publication of its Draft Guidance on New Dietary Ingredients (NDIs) in July 2011.
The FDA issued the long-awaited draft guidance document for companies in the dietary supplement industry in order to provide guidelines for when and how to file NDI pre-market notifications in which the marketer of the NDI must provide safety data for FDA review and acceptance before the NDI can be legally marketed. Such 75-day pre-market notifications are required for dietary ingredients intended to be sold in the U.S. after the date of the passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA) on October 15, 1994.
In its comments, ABC calls for the FDA to adopt and officially recognize the existing consolidated list of so-called Old Dietary Ingredients (ODIs)—i.e., dietary ingredients sold in the U.S. market prior to the passage of DSHEA.* The FDA has previously declined to recognize such lists as having any official bearing in the determination of an ingredient's pre-DSHEA status. ODIs are not normally subject to an NDI notification in order to establish a basis for their safety; their general safety is presumed.
ABC noted that its proposal for FDA recognition of an official list of ODIs is intended to ensure that the list is dynamic, not static, and also subject to revision with added ingredients, as appropriate. ABC also emphasized that the existence of such a list should not be misinterpreted as a legal burden on industry members to prove that ingredients in dietary supplements are ODIs—there is currently no such legal requirement for industry to do so.
ABC also called for the creation of an expert advisory panel of industry and other appropriate experts who can clarify the entries in the "List of Old Dietary Ingredients."* The panel would evaluate any entries that may be ambiguous (e.g., plants included by their common and Latin names) and ascribe the correct plant part(s) known to have been sold in the market prior to passage of DSHEA.
"One of the biggest problems in the NDI notification process has been the ambiguity of what ingredients are in fact ODIs, so-called 'grandfathered' ingredients that are not required to go through the NDI notification procedure," said ABC Founder and Executive Director Mark Blumenthal. "What ABC is proposing is a process in which more clarity can be brought to this entire area. Eventually this would reduce or eliminate confusion and provide benefit to both industry and the FDA."
Additionally, ABC's comments address the matter of whether the proposed draft NDI guidelines from the FDA create a virtual pre-market approval system; raise questions about the FDA's proposed requirement for notifications on all new dietary supplements—not just new ingredients; and examine the issue of solvents used in the production of botanical extracts, among other issues.
The complete text of the ABC comments can be found here.
* The "List of Old Dietary Ingredients" was published in 1999 by the then-named Utah Natural Products Alliance (now the United Natural Products Alliance; UNPA). It is a consolidation of lists of ODIs prepared by three other trade associations: the American Herbal Products Association (AHPA), the Council for Responsible Nutrition (CRN), and the then-named National Nutritional Foods Association (now the Natural Products Association; NPA).
The FDA issued the long-awaited draft guidance document for companies in the dietary supplement industry in order to provide guidelines for when and how to file NDI pre-market notifications in which the marketer of the NDI must provide safety data for FDA review and acceptance before the NDI can be legally marketed. Such 75-day pre-market notifications are required for dietary ingredients intended to be sold in the U.S. after the date of the passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA) on October 15, 1994.
In its comments, ABC calls for the FDA to adopt and officially recognize the existing consolidated list of so-called Old Dietary Ingredients (ODIs)—i.e., dietary ingredients sold in the U.S. market prior to the passage of DSHEA.* The FDA has previously declined to recognize such lists as having any official bearing in the determination of an ingredient's pre-DSHEA status. ODIs are not normally subject to an NDI notification in order to establish a basis for their safety; their general safety is presumed.
ABC noted that its proposal for FDA recognition of an official list of ODIs is intended to ensure that the list is dynamic, not static, and also subject to revision with added ingredients, as appropriate. ABC also emphasized that the existence of such a list should not be misinterpreted as a legal burden on industry members to prove that ingredients in dietary supplements are ODIs—there is currently no such legal requirement for industry to do so.
ABC also called for the creation of an expert advisory panel of industry and other appropriate experts who can clarify the entries in the "List of Old Dietary Ingredients."* The panel would evaluate any entries that may be ambiguous (e.g., plants included by their common and Latin names) and ascribe the correct plant part(s) known to have been sold in the market prior to passage of DSHEA.
"One of the biggest problems in the NDI notification process has been the ambiguity of what ingredients are in fact ODIs, so-called 'grandfathered' ingredients that are not required to go through the NDI notification procedure," said ABC Founder and Executive Director Mark Blumenthal. "What ABC is proposing is a process in which more clarity can be brought to this entire area. Eventually this would reduce or eliminate confusion and provide benefit to both industry and the FDA."
Additionally, ABC's comments address the matter of whether the proposed draft NDI guidelines from the FDA create a virtual pre-market approval system; raise questions about the FDA's proposed requirement for notifications on all new dietary supplements—not just new ingredients; and examine the issue of solvents used in the production of botanical extracts, among other issues.
The complete text of the ABC comments can be found here.
* The "List of Old Dietary Ingredients" was published in 1999 by the then-named Utah Natural Products Alliance (now the United Natural Products Alliance; UNPA). It is a consolidation of lists of ODIs prepared by three other trade associations: the American Herbal Products Association (AHPA), the Council for Responsible Nutrition (CRN), and the then-named National Nutritional Foods Association (now the Natural Products Association; NPA).
