FDA Nutrient Claims Notice Requirement
Structure & Function Claims
All Vitamin Companies Must File!
Here is How to File with Help from The Vitamin Lawyer
"Supporting industry compliance with FDA and FTC regulations."
From: Ralph Fucetola, JD,Credentials
INDEX: Urgent, Rule, Regulation, Services, Who Must File, How to Apply, How to Pay, Help, Types of Claims.
URGENT REMINDER OF FILING REQUIREMENT
Urgent reminder to all nutrient purveyors: the extended time to file, with the FDA, your Notifications of Structure and Function Claim Statements expired February 1, 2001 -- ALL notices, one for each product you currently sell, must have been filed by that date. This is an important aspect of vitamin industry cGMPs (Current Good Manufacturing Practices) and a Federal regulatory requirement.
NEW PRODUCTS OR CLAIMS REQUIRE NEW NOTICES WITHIN 30 DAYS OF MARKETING.
The general rule is, no later than 30 days after the first marketing of a dietary supplement that bears one of the statements listed in Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act, the manufacturer, packer, or distributor of the dietary supplement shall notify The Secretary of Health and Human Services that it has included such a statement on the label or in the labeling of its product. The statements that are included are the Classical Deficiency Disease, General Wellness and Structure and Function Claims that nearly all nutrient supplement marketers make. The "label" is what is affixed to the bottle, "labeling" is the hang tag or other company literature (including advertising) about the product.
A Structure or Function Claim is one that characterizes the relation between a nutrient and the normal structure and function of the body. These are the standard dietary supplement claims.
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 firstname.lastname@example.org (with Health Claim in the subject line) for information about the Health Claim procedure. See also: FDA & FTC Requirements.
I have carefully reviewed the Regulation (21 CFR 101.93) implementing the Statute Section and have prepared the appropriate format for the required Nutrient Claims Notice. The format meets the requirements of the Regulation and is adapted to email receipt of the necessary information, with return of the form ready for printing and filing, by email.
SERVICES FOR NUTRIENT MARKETERS
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
HOW THE VITAMIN LAWYER CAN HELP YOU FILE
In order to qualify for this special Claim Notice service, certain information will have to be provided to me by email, to email@example.com (with Claim Notice in the subject line). This information includes:
(i) The name and address of the firm making the notice;
(ii) The text of the statement that is being made for each ingredient;
(iii) The name of the dietary ingredient and dietary supplement brand name(s).
(iv) The name and position of the responsible person who will certify in writing that (a) the Notice is true and accurate and (b) the firm has on hand substantiation for the Claims made. This certified statement is the "self-policing provision" of the regulation. It puts a substantial legal burden on the officers of vitamin industry companies.
"Prior substantiation" of advertising claims, always a requirement of the FTC, is now enforceable through the self-policing mechanism of the FDA required Nutrient Claims Notices.
Please also see my article on The Right of the Public to Know the Truth
- the Standard of Substantiation.
Further information on services and how to pay with Pay Pal over the internet (accepts debit and credit cards and electronic checks) --vitservices.html
WHO MUST FILE
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.
YOU MUST ACT AT ONCE TO PROTECT YOUR BUSINESS INTERESTS.
PRODUCTS THAT MAKE CLAIMS WITHOUT THE NOTICE MAY BE BANNED FROM THE U.S. MARKET!
The Vitamin Lawyer is here to help...vitservices.html
See also: Labeling Requirements
Of course your web site also needs a Site Use,
Privacy, Disclosure, Disclaimer Statement!
CGMPs are Coming to the Vitamin
Proposed Current Good Manufacturing Practices
Is Your Company Ready?!? Click below to learn more!
Vitamin Lawyer Report
Contact the Vitamin Lawyer by email to arrange services.
Please put "Claims Notice" in the Subject Line.
Here is a synopsis of the four types of possible Claims:
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
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.
ã2000, 2001, 2003
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