December 1, 2011
The Natural Products Association (NPA) requested FDA rewrite its New Dietary Ingredient (NDI) Draft Guidance before it issues a final version, and the trade association said it would be glad to help in this endeavor. In comments submitted to FDA in response to the agencys Draft Guidance, NPA said, "The NDI Draft Guidance completely eviscerates the food additive prohibitions that Congress so carefully placed in Dietary Supplement Health and Education Act of 1994 (DSHEA) and also contravenes the deep-rooted DSHEA policy in favor of consumer freedom of choice and support for smaller business."
NPA vice president for scientific and regulatory affairs, Cara Welch, Ph.D., said, Congress set appropriate parameters regarding the safety of new dietary ingredients, and NPA supports those safety measures. Unfortunately, this draft guidance goes well beyond what was envisioned by Congress.
In it comments to FDA, NPA noted 11 points in particular that should be revised:
"Grandfather" list of old dietary ingredients
The Draft Guidance says no list exists of ingredients that were on the market before DSHEA was passed (thus, making them "old" and not required to have an NDI notification [NDIN]). However, NPA said FDA should accept industry-developed lists from the National Nutritional Foods Association (now NPA), the Council for Responsible Nutrition (CRN), the American Herbal Products Association (AHPA) and the United Natural Products Alliance (UNPA).
Clarification of the 75-day review period
NPA said FDA should not restart the 75-day review period time clock every time a NDIN is rejected due to a technical feature omission. Instead, the trade organization asks FDA to add 25-day period extensions to the NDIN review process each time the process is stalled due to a technical error.
Finished product notification requirements
FDA should not require NDINs for each finished product with an NDI, but should instead require a NDIN for each ingredient as it's introduced to the market.
Identical products require new NDIN
The Draft Guidance said each manufacturer or distributor would need to submit an NDIN, even if the product contained the same ingredients as a product that already has an NDIN. However, NPA said interim communication with FDA has refuted this obligation. In fact, Daniel Fabricant, Ph.D., director of dietary supplement programs at FDA, said a manufacturer may not need to submit an new NDIN if the ingredient was already in a previously submitted NDIDN at the NDI Town Hall at SupplySide West in October. Therefore, NPA asks FDA to clarify this point.
Safety testing requirements
NPA requests FDA be more flexible when it comes to showing safety data of NDIs when they have little history of use. The organization said FDA should apply different levels of testing depending on the type of ingredient. They categories NPA suggested include new chemical entity, new manufacturing process of an existing ingredient, and new mineral form of an existing labile moiety.
Chemically altered definition
NPA said FDA is being too rigid in its definition of a "chemically altered" ingredient, which would require a NDIN. NPA said when Congress indentified examples of manufacturing processes that did not constitute chemical alteration ("minor loss of volatile components, dehydration, lyophilization, milling, tincture or solution in water, slurry, powder or solid in suspension"), it did not give an exhaustive list. However, according to the Draft Guidance, this list is exhaustive.
Ingredient activity vs. concentration
The Draft Guidance said an NDIN is not needed for products that don't change the daily intake level or conditions of use. However, NPA said FDA didn't clarify if this also applies for products that use activity level, such as enzymes or probiotics, instead of concentration to determine dose.
NPA asked FDA to differentiate probiotics from harmful pathogenic bacteria. NPA said probiotics offer health benefits and should be considered dietary ingredients, but the Draft Guidance does not confirm this.
Even though synthetic botanicals are not a constitute of an herb or botanical, they should still be considered a dietary ingredient, according to NPA. NPA argued that FDA has allowed synthetic forms of vitamins, minerals and amino acids. Plus, NPA said, eliminating synthetic botanicals simply because they are synthetic doesn't have anything to do with safety.
New drug investigation
The Draft Guidance said if an ingredient is part of a investigational new drug (IND) application, it is not a dietary ingredient. However, NPA said many researchers are required to file IND applications to get clearance from institutional review boards before conducting clinical research, even if they are not planning on marketing the ingredient as a drug. NPA asked for a clarification on this issue.
Intellectual Property (IP)
NPA asked FDA to outline the precautions it will take to insure IP related to NDIs.
Through DSHEA, Congress envisioned a system that would allow products already on the market to remain available to the consumer while creating a reasonable mechanism for new ingredients to enter the market," said NPA executive director and CEO John. "The Draft Guidance does neither. Rather, it proposes an NDI process that would result in dampened innovation, more expensive and fewer products, and excessive paperwork, robbing the industry and FDA of scarce resources. The overall impact would be felt by customers, retailers and suppliers alike, hitting small businesses especially hard."
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