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Ralph Fucetola JD


Nutrient Labeling and Advertising


The Vitamin Lawyer

Nutrient Labeling and Advertising
http://www.vitaminlawyer.com/

Laws and Regulations Enforced by FDA:  http://www.cfsan.fda.gov/~dms/reg-2.html

Dietary Supplement Health & Education Act of 1994, http://vm.cfsan.fda.gov/~dms/dietsupp.html
DSHEA text: http://www.healthy.net/public/legal-lg/fedregs/S784_ENR.HTM

There are a number of resources available from the Food and Drug Administration (FDA) regarding the labeling and advertising of dietary supplements on the Internet. Among these are the Statement of Identity, Nutrition Labeling, and Ingredient Labeling of Dietary Supplements Small Entity Compliance Guide at http://www.cfsan.fda.gov/~dms/ds-label.html and the Structure/Function Claims Small Entity Compliance Guide at http://www.cfsan.fda.gov/~dms/sclmguid.html. The Federal Trade Commission also has on-line resources available, for example, Dietary Supplements - An Advertising Guide for Industry at http://www.ftc.gov/bcp/conline/pubs/buspubs/dietsupp.htm.

"Labeling" is regulated by the FDA under DSHEA. "Advertising" is generally regulated by the FTC under its "truthful and not misleading" substantiation rules. Note that the distinction here is between statements on
the company's own "sale" site and on third party sites where the company advertises. This does not apply to third party sites that provide information that is not paid to be posted there by the company. So this FDA letter is mostly about which agency will have control. It is also important to note that the FTC has recently publicly disagreed with some FDA approaches as not sufficiently protective of free speech rights.

In November 2001 the FDA responded to a question from a vitamin purveyor regarding the status of advertising and third party links on the Internet.

"FDA believes that, in certain circumstances, information about FDA-regulated products that is disseminated over the Internet by, or on behalf of, a regulated company can meet the definition of labeling in section 201(m)
of the FDCA. For example, if a company were to promote a regulated product on its web site and allow consumers to purchase the product directly from the web site, the web site is likely to be "labeling." The web site, in that case, would be written, printed, or graphic matter that supplements or explains the product and is designed for use in the distribution and sale of the product.

"To provide an example from the other end of the spectrum, some product-specific promotion presented on non-company web sites that is very much similar, if not identical, to messages the agency has traditionally regulated as advertisements in print media (e.g., advertisements published in journals, magazines, periodicals, and newspapers) would be viewed as advertising. These are just examples at the extremes... the agency will proceed on case-by-case basis in determining what is "labeling."

"The agency sees no reason to treat Internet information of food companies differently from Internet information of other FDA-regulated industries. ***

"FDA has explored developing a guidance on promotion of FDA-regulated products on the Internet, but has decided not to issue a document at this time. The agency believes that any rule or guidance on this issue would be quickly outdated due to the ongoing rapid changes in the Internet and its use. As a result, issuing a rule or guidance may stifle innovation and create greater confusion among industry and the public. Therefore, for the time being, FDA will continue to use a case-by-case approach based on the specific facts of each case."

The Vitamin Lawyer has asserted that recent court cases are changing the regulatory climate and improving our ability to make truthful claims. Now comments by the FTC, responding to FDA concerns about untruthful advertising shows that we know where we are going!

In mid-2002, the FTC, in response to proposed FDA advertising restrictions, observed that banning a claim for being misleading would be unconstitutional, but modifying the claim would not be. The agency noted that reviewing advertising language for products such as dietary supplements needs to be flexible to allow a broader range of claims so long as they are accurate and not misleading.

The FTC recommended that the FDA should look at methods that favor disclosures and qualifications in lieu of outright bans. The Commission further stated that "our experience in policing advertising and labeling claims may assist FDA in its efforts to conform its own regulatory practices to the First Amendment, while still advancing its important mission to protect and promote public health".

Well, now we have the agencies vying to see which agency can protect free speech the best! So think disclaimers, disclaimers, disclaimers... See, The Right of the Public to the Truth for the Supreme Court's take on these Commercial Speech issues.

Consider the FDA's statement, "some product-specific promotion presented on non-company web sites that is very much similar, if not identical, to messages the agency has traditionally regulated as advertisements in print media (e.g., advertisements published in journals, magazines, periodicals, and newspapers) would be viewed as advertising..." This means "advertising" that is purchased by a company on another's web site.
It doesn't mean a third party web site (such as a search engine, public bulletin board and the like) that gives information to the public, including where to find dietary supplements.

Thus, an approach to Internet advertising that focuses on third party links and recommendations can allow the public access to the widest array of truthful information about the availability of dietary supplements.

Ralph Fucetola, JD

Update:  11/11/04 -- Over the past weeks, leading up to a meeting with industry leaders scheduled for 11/15, the FDA has exposed its three-pronged surveillance and quality assurance strategy, to enhance the predictability and consistency of the agency's scientific evaluations of dietary supplements and the safety of product ingredients.

FDAs regulatory strategy consists of guidance documents, regulations and science-based compliance and enforcement mechanisms. "These initiatives refine the direction the agency is taking to regulate dietary supplements," said FDA acting Commissioner Lester Crawford. "We now have a clear roadmap to share with the dietary supplement industry"

The FDA's strategy focuses on monitoring and evaluating product and ingredient safety, with special emphasis on (1) new dietary ingredients; (2) ensuring product quality; and (3) surveying and evaluating product labeling.

http://www.fda.gov/OHRMS/DOCKETS/98fr/2004n-0458-bkg0001.pdf.
http://www.fda.gov/bbs/topics/news/2004/NEW01130.html.

The agency has also issued a draft guidance to assist companies in gathering the scientific information needed to support a labeling claim.  The guidance describes the amount, type and quality of evidence needed to substantiate a labeling claim on a dietary supplement, as required under section 403(r)(6) of the Federal Food, Drug and Cosmetic Act. That section requires that dietary supplement labeling claims, including nutritional deficiency, structure/function or general well-being claims, must be truthful and not misleading.

To meet this statutory requirement, companies must possess adequate evidence for each reasonable interpretation of the claim. The agency said it would use the FTC standard of "competent and reliable scientific evidence" to substantiate a claim.

The draft guidance, titled "Substantiation for Dietary Supplement Claims Made Under Section 403(r)(6) of the Federal Food, Drug and Cosmetic Act," was published in the Nov. 9 Federal Register and can be found at:

http://www.fda.gov/OHRMS/DOCKETS/98fr/2004d-0466-gdl0001.pdf.
http://www.fda.gov/bbs/topics/news/2004/NEW01130.html.

ã 2002, 2004 v 11/12/04

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 Ralph Fucetola JD

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