05/18/2012

      Re: Docket No. FDA-2011D-0376: "Draft Guidance for Industry; Dietary Supplements: New Dietary Ingredient Notifications and Related Issues"

To Whom It May Concern:

      This letter is a Comment regarding the FDA's recent Draft Guidance for New Dietary Ingredient (NDI) Notifications. I am a retailer of dietary supplements, and I have been in the natural products industry for years. In all this time, I have never had a customer complaint of a serious side effect or a safety problem, for any of the hundreds of supplement products that I sell.

      I realize that the supplement industry has been asking the FDA for a Guidance document for many years, in order to have a clearer idea of which safety and lab tests are necessary for showing that a new dietary ingredient (NDI) is appropriately safe. But I have looked at the Draft Guidance, and have read many of the articles in the trade industry press, and I have some grave concerns that this Draft Guidance goes too far, and needs to be scaled back.

• It appears that many ingredients that have been on the market since before DSHEA, before 1994, are now being questioned and thought to be NDIs.
• Formulations that consist of "grand-fathered in" dietary ingredients, blended or formulated in new ways, should not be considered NDIs, and Notifications should not be required for them.
• This Guidance does not follow the rules or the spirit of DSHEA.
• For NDIs that already have successful Notifications filed with the FDA, these Notifications should also apply to other companies using that same NDI. Otherwise, only the largest supplement companies (and also Big Pharma companies) will be able to afford the extensive tests for their own Notification for a slightly different use of the same NDI.
• It will be much too expensive—and not necessary for public safety—for new dietary ingredients to get to the market. So, many beneficial new supplement products will either never be available, or will be much too expensive to sell.
• It appears that Probiotics will be treated as non-supplements, and will disappear from the market completely.
• Most of my customers are very concerned that this new FDA Draft Guidance will severely limit the types of supplements that are on the market, and also will reduce the number of new & innovative supplements.
• The net result is that I, and other retailers, may eventually go out of business. We all want supplements, including new dietary ingredients, to be safe for the public. And in my experience, the supplements I sell—including new supplements—have shown that level of safety already.

      Thus, I hope that the department at CFSAN revising this Draft Guidance will take my concerns (and those of many other retailers and tens of thousands of consumers) into consideration.

Please add your own conclusions...

Sincerely,

Full Name: