2004N-0454 - Dietary Supplements; Premarket Notification for New Dietary Ingredient Notifications; Public Meeting
FDA Comment Number : EC58
Submitter : Mr. Barry Sugarman Date & Time: 12/08/2004 05:12:57
Organization : Diverstech Co.
Dietary Supplement Industry
Category :
Issue Areas/Comments
GENERAL
GENERAL
Dear Sir or Ma'am,

I am an ex-CEO of a pharmaceutical manufacturing firm, and consultant with over 25 years experience in the drug, device, and dietary supplement industry. I have the following comments on this New Dietary Ingredient proposal:

1) FDA's preamble in the meeting announcement does not distiguish ingredients that are defined in the law, 21 USC 321(ff) as dietary supplements, and that those materials that meet this definition are not subject to the requirement that the materials be in the food supply prior to 10/15/1994. In other words, the law expressly states that vitamins, minerals, herbs or botanicals, amino acids, or a concentrate, metabolite, constituent, extract, or combination of these are not new ingredients irrespective of their marketing or food supply status prior to 1994. FDA should clarify this, and also clarify that an herb need not appear in Herbs of Commerce in order to be exempt from the filing of a New Dietary Ingredient notice.

2) FDA should clarify that any ingredient present in any common vegetable, fruit or food in any detectable quantity is a dietary supplement that would not require a New Dietary Ingredient notice. Because of the significant improvements in analytical technology in recent years, more and more food constituents that were not detectable or able to be characterized can now be detected and characterized, and the DSHEA statutes did not intend for these newly detected materials to be New Dietary Ingredients.

3) FDA's message with regard to the fact that a dietary supplement must have been in the food supply before 10/15/1994 does not comply with the express provisions of the statute in that the statute specifically provides for metabolites of a material to also be dietary supplements. In other words,
there may be a human metabolite of a food product that is a metabolite of a food material, concentrate or other dietary supplement that is not in the food supply, but is a valid human metabolite of a dietary supplement ingredient that is in the food supply. FDA should clarify that this is acceptable.

4) FDA should clarify that a history of use may include published literature, history books, or other documents that reasonably support facts showing that the product was in use in any food supply anywhere in the world will suffice for the prior use requirement.

5) FDA should publish a list of dietary supplement it currently thinks may not qualify as Dietary Supplements and should permit industry and other interested parties a reasonable opportunity to provide FDA information that the material meets either the definitions under DSHEA, or the safety standards that FDA requests.

6) FDA should clarify specifically what its requirements are in order for any New Dietary Ingredient that does require an NDI notice meet so that industry can plan and comply. Most industry members desire a good working relationship with FDA, and desire that products be safe. FDA should delineate their proposed safety standards.

7) With regard to testing of dietary supplements, there are many, many test methods developed for ingredients. FDA should announce each round of testing in advance, and give industry an opportunity to comment on any proposed test methods, and their validity toward particular supplements or products. The field of analytical testing of supplements is still evolving, and methods vary significantly, and there are many combination products that cause interferences in the testing of particular materials that are either insurmountable, or very
difficult to overcome.

Thank you very much for consideration of these comments.

Barry Sugarman, B.S.ENGR., President
Diverstech Co.
1730 Michael Lane
Pacific Palisades, CA 90272-2037 USA
Phone 310-355-6046
Fax 310-454-9592
mailto:barry@diverstech.com