Vitamin Lawyer News, FDA Claim Notice, Notice Deadline, Nutrient Supplement,Ralph Fucetola, www.vitaminlawyer.com

This procedure does NOT include Health Claims (claims that characterize the relation between a nutrient and a disease) which require prior FDA approval under a Health Claim Petition procedure. Contact me directly at ralph.fucetola@usa.net (with Health Claim in the subject line) for information about the Health Claim procedure. See also: FDA & FTC Requirements.

As a special service to the nutrient marketing community, I will prepare the Notices on behalf of distributors for a discounted price of $200.00 per product for email-generated statement information. Please note: if you sell the same product under several brand names, all the brand names can be included in one Notice. If the FDA objects to the Notice (an unusual, but permitted response) additional time will be billed at my discounted internet rate of $200 per hour. In addition, if I have to determine what Claims you are actually making, the additional time required will also be billed at $200 per hour. Out of pocket expenses are additional. The Notice I generate for your company will be in printable form, ready for filing with the correct FDA address and references. How to pay.

You also need to be aware that other notices may be required when you bring new products to market. The new cGMP* requirements will most likely include location notice requirements. Additionally, for example, if an ingredient is a New Dietary Ingredient (not grandfathered under DSHEA) you will need to file a 75 day pre-market notice, with extensive safety data. You can look at recent New Dietary Ingredient approvals at http://www.cfsan.fda.gov/~dms/ds-ingrd.html. The Vitamin Lawyer is available to help you file a Pre-Market NDI Petition. Please email me with "NDI Notice" in the subject line for details.

Says the FDA: "The term "new dietary ingredient" means a dietary ingredient that was not marketed in the United States in a dietary supplement before October 15, 1994. (See section 413(c) of the Federal Food, Drug, and Cosmetic Act (the act), 21 U.S.C. 350b(c)). There is no authoritative list of dietary ingredients that were marketed in dietary supplements before October 15, 1994. Therefore, manufacturers and distributors (you) are responsible for determining if an ingredient is a "new dietary ingredient" and, if not, for documenting that a dietary supplement that contained the dietary ingredient was marketed before October 15, 1994."

* - cGMPs - Current Good Manufacturing Practices, see: GMP Report

Further information on services and how to pay with Pay Pal over the internet (accepts debit and credit cards and electronic checks) -- vitservices.html

If your firm appears on the product label as the owner of the product, you must file the Notice. Each and every Claim must be included and an amended Notice is to be filed whenever a new Claim is made. This notification procedure marks the end of the "open market in claims" which has existed since the Dietary Supplement Health and Education Act of 1994 (DSHEA) was adopted. As the Regulations under that Act have been proposed and adopted, the onus for maintaining the required filings has fallen upon the nutrient seller.

Of course your web site also needs a Site Use,
Privacy, Disclosure, Disclaimer Statement!
www.disclaimersforsale.com

CGMPs are Coming to the Vitamin Industry!
Proposed Current Good Manufacturing Practices
Is Your Company Ready?!? Click below to learn more!
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Contact the Vitamin Lawyer by email to arrange services.
ralph.fucetola@usa.net
Please put "Claims Notice" in the Subject Line.

1. General Wellness Claims -- such claims may be made so long as they meet the FTC standard of "truthful and not misleading." The distributor must have adequate "prior substantiation" for such claims.

2. Structure and Function Claims -- these are claims about the relationship between nutrients and normal body structure and function. The same substantiation standard applies to them and FDA regulations require that a Statement of Claims be filed with the FDA within 30 days of first making a specific claim. The FDA reviews these claims solely to see if the language used states a Structure and Function Claim, but does not evaluate the adequacy of the substantiation.

3. Health Claims -- these claims characterize the relationship between a nutrient and a disease or health condition. Such claims may not be made unless the FDA has given prior approval and a formal Petition is required.

4. Medical Claims -- claims to diagnose, treat, prevent, mitigate, or cure disease are not permitted. Such claims result in the nutrient being treated as a "drug" and requiring full FDA drug approval.