FDA will address what types of Web site material constitute labeling on a case-by-case basis, the agency says in a recent response to a Washington Legal Foundation citizen petition.

Although the agency notes it "has explored developing a guidance on promotion of FDA-regulated products on the Internet, [it] 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"The agency believes that any rule or guidance on this issue would be quickly outdated due to the ongoing rapid changes in the Internet and its use," FDA says in a Nov. 1 letter. "As a result, issuing a rule or guidance may stifle innovation and create greater confusion among industry and the public."

WLF filed a citizen petition April 13 requesting FDA "take appropriate administrative action that would make it clear that information found on a company's Internet Web site does not constitute labeling of that company's products which are otherwise subject to FDA regulation under the [FD&C] Act."

The petition asserted that since Internet text comprises advertising, it falls within the purview of the Federal Trade Commission. FTC's criteria are "more consistent with the First Amendment than FDA's burdensome labeling requirements for health and disease claims," WLF maintained (¹ Also see "Internet Content Equivalent To Advertising, Warrants FTC Oversight - WLF" - Pink Sheet, 23 April, 2001., p. 7).

The petition was submitted three months after FDA sent a warning letter to Ocean Spray contesting "unau-thorized health claims" on the juice company's Web site (² Also see "Ocean Spray Request For Web Site Content Guidance Follows FDA Warning" - Pink Sheet, 26 February, 2001., p.18).

Ocean Spray's Web site claims, such as "May help the body fight cancer" and "Research shows grapefruit slows breast cancer growth," implied the products "are intended to treat, cure or mitigate a disease," FDA maintained in the Jan. 19 warning letter.

Ocean Spray removed from its Web site all the elements cited in FDA's warning letter. However, in a Feb. 9 letter the company asked FDA for guidance and clarity on the types of product health benefit statements suitable for company Web sites.

Although WLF's petition was not submitted on behalf of Ocean Spray, it was prompted by FDA's contact with the company.

As an alternative to its broader request concerning Web site content for FDA-regulated products, WLF asked the agency to specifically exempt food companies' Internet information from labeling requirements.

The agency says it "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 the FD&C Act.

"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,'" FDA says.

"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," the agency asserts.

The Nov. 1 letter continues: "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."

The agency points to a 1948 U.S. Supreme Court case, Kordel v. U.S., upon which authority FDA and lower courts have interpreted "labeling" to include "brochures, booklets...motion picture films, film strips... sound recordings...and similar pieces of printed, audio, or visual matter descriptive of a drug...which are disseminated by or on behalf of its manufacturer, packer or distributor."

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

At the time it submitted the petition, WLF said it would consider filing suit to compel the agency to adopt a rulemaking or guidance on Internet content.

The group now says it will monitor FDA's activities with regard to Web site content but has not ruled out the possibility of a future lawsuit.

Web Site Labeling Claims Guidance Would Be “Quickly Outdated” – FDA

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