Washington Report:
Alternative Medicines and Treatments

©Copyright 1998 by Emalee Murphy, Esq., McKenna & Cuneo, LLP, Washington, DC, USA
(Explore Issue: Volume 9, Number 1)

I. FDA Regulation of Internet Information

One of the hottest advertising media is the Internet. Through the Internet, consumers and health care practitioners can learn about products and remedies from around the world. For health regulators in the USA, Canada, Mexico, and Europe, access to information about health care products and remedies not approved within their jurisdictions has prompted regular "internet surfing days" to identify product advertising considered in violation of the law. Not surprisingly, the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) have participated in these surfing expeditions and have taken steps to require that companies modify their websites, even those that originate outside the United States if they describe unapproved drugs and devices or unapproved uses for these products.

At present, there are no U.S. laws or regulations specifically addressing the dissemination of information about FDA regulated products through the internet. However, FDA's current position is that internet information about an FDA-regulated product is "labeling"¹ Based on this determination, FDA has issued a number of warning letters and notices of violation ("NOV") to companies promoting products through the internet. Most of these letters were issued to device manufacturers who failed to list the devices or to notify the FDA as required by section 510 of the Federal Food, Drug, and Cosmetic Act ("FDCA"). Two NOV letters were delivered to prescription drug manufacturers based on FDA's determination that the labeling (internet information and other promotional material) was false and misleading and a violation of Section 502(a) of the FDCA. One letter was issued to a manufacturer regarding a dietary supplement that FDA determined to be a new drug based on information contained on the company website. The in
troduction of a new drug without an approved new drug application results in a violation of Section 301(d) of the FDCA. However, of particular note, none of these letters was issued to a non-U.S. entity.

Although foreign companies do not appear to have been subject to Warning or NOV letters based upon their internet promotion, in June 1996, a Netherlands company, ALP Food Supplements, was the subject of an Import Alert, partially as a result of its solicitation activities towards U.S. citizens through the internet for foreign versions of approved U.S. prescription drugs. FDA also is checking foreign websites as part of its review of product labeling for imported products and has taken the position that internet statements are within its jurisdiction.

FDA has held a public meeting to discuss issues related to the promotion of FDA-regulated medical products on the internet. Following the meeting, FDA indicated its intention to issue a draft internet guidance during the summer of 1997. As of this date, the draft guidance has not been issued and it may be that FDA wants to have the position of the World Health Organization's Internet Promotions Ad Hoc Working Group regarding internet promotion prior to release of the FDA guidance. The WHO group was formed in response to concerns regarding the uncontrolled across-the-border trade of unapproved medical products and FDA has announced its intent to be involved in any policies developed by WHO.

Although the FDA draft internet guidance has not been released, based on the questions posed by FDA in the federal register notice and at the public meeting in October of 1996, we believe FDA will consider the following factors in determining whether a company located outside the U.S. is promoting its unapproved products to U.S. citizens:

1. If the server is located in the United States (e.g. America Online, Erols), FDA may consider a company using the server as promoting its products to U.S. citizens.
2. Disclaimers in the website promotional materials stating that the product is not approved for use in the United States may provide some protection. However, even where disclaimers are used, FDA has stated that they may not be sufficient to prevent a determination that a foreign company is promoting its products to U.S. citizens.
3. What language is used? For example, is an Italian company's website printed in Italian or English? If the product is approved for use in Italy, and not in any English speaking country, FDA may consider the use of the English language as an intent to promote the product to U.S. citizens.
4. Are passwords used? Passwords can be used to limit access to information to those for whom the information is intended. If a foreign company receives a request from a U.S. citizen for a password to view promotional material on products not approved for use in the United States, the company could deny the request, and thereby maintain control over who has access to the information.
5. How is the information presented? For example, is it organized with subdivisions for each country? Such subdivisions may indicate to the website visitor that information contained under a Canadian subdivision is not directed to the Non-Canadian or conversely that an American subdivision (indicated by text or symbol) is intended to attract U.S. customers.
6. What is the legal status of the product in the country from which the product is promoted? If the product cannot be lawfully sold in the country from which it is promoted, FDA may be more likely to determine that the company is promoting the product to U.S. citizens if the information is accessible by U.S. citizens.
7. What are the regulations concerning promotional material in the country from which the product is being promoted? For example, if the country from which the product is being promoted does not allow direct-to-consumer promotion of prescription drugs, such promotion may be deemed to be an intent to promote those drugs to U.S. citizens.

If FDA makes a determination that a foreign company is promoting unapproved products to U.S. citizens, it may issue a warning letter to the company and an Import Alert to all U.S. ports of entry which will effectively detain and deny entry into the United States of all shipments from that non-U.S. company.

II. Federal Trade Commission Activity Regarding Advertising of Dietary Supplements and Food Products

In response to the growing dietary supplement market and regulatory changes addressing this market, the Federal Trade Commission ("FTC") recently released an advertising guide for the dietary supplement industry. Federal Trade Commission, Dietary Supplements: An Advertising Guide for Industry (visited December 17, 1998) (http://www.ftc.gov/bcp/conline/pubs/buspubs/dietsupp.htm). The guide describes the basic principles of FTC law and uses examples from the supplement industry to illustrate how those principles apply in practice.

The guide also addresses the interaction of FTC advertising policy and the Food and Drug Administration's ("FDA") regulation of labeling under the Dietary Supplement and Health Education Act ("DSHEA"). As applied to dietary supplements, the FDA has primary responsibility for claims on product labeling, including packaging, inserts, and other promotional materials distributed at the point of sale. The FTC has primary responsibility for advertising claims, including print and broadcast ads, infomercials, catalogs, and similar direct marketing materials.

Marketing on the Internet is subject to regulation in the same fashion as promotions through any other media. As mentioned above, the FTC, the FDA, and many state Attorney Generals and consumer protection offices have been actively monitoring claims being made on the Internet. On October 21-22, 1998, the FTC was involved in the first International Health Claim Surf along with eighty other agencies and organizations from twenty-five different countries. Internet surfers found 1,200 Web sites advertising products with potentially false
claims to cure serious medical conditions. Once the sites were identified, each company was sent an e-mail message warning that Internet ads must have scientific proof to support their claims. The FTC has reported that it may use the information found on the Internet to begin legal proceedings.

The FTC also released a report on a research project it conducted to test how consumers interpret food and supplement advertising claims. Federal Trade Commission, Generic Copy Test of Food Health Claims in Advertising, (visited December 17, 1998) (http://www.ftc.gov/os/1998/9811/foodhealrep.htm) The report addressed how consumers interpret claims based on emerging science, as well as how consumers interpret certain types of nutrient content claims.

III. Import Of Unapproved Products Through the Mail for Personal Use

In 1989, FDA developed guidelines concerning the regulation of unapproved FDA-regulated products imported through the mail by U.S. citizens. See Regulatory Procedures Manual, Part 9, Chapter 9-71, Coverage of Personal Importations. Although FDA maintains that it can refuse entry of all products deemed violative of the Federal Food, Drug, and Cosmetic Act and its implementing regulations, through these guidelines it announced its decision to grant FDA personnel enforcement discretion in allowing the admission of violative items if certain conditions exist. The guidelines are not applicable to commercial shipments.² In determining whether to allow the import of unapproved drugs into the United States for personal use, the FDA will consider a more permissive policy under the following conditions:

1. The intended use is appropriately identified, the use is not for treatment of a serious condition, and the product is not known to represent a significant health risk; or
2. The intended use is unapproved for treatment of a serious condition, but effective treatment is not available domestically through either commercial or clinical means and:

1. The company selling the product has not promoted the product or solicited orders from U.S. citizens;
2. The product is considered not to represent an unreasonable risk; and
3. the individual seeking import of the product affirms in writing that it is for the patient's own use and provides the name and address of the doctor licensed in the U.S. responsible for his or her treatment with the product or provides evidence that the product is for the continuation of treatment begun in a foreign country.

The guidelines further recommend issuance of an Import Alert to detain and deny future entry of the foreign company's product(s) if it is found that:

1. The product for personal importation represents either a direct or indirect risk;
2. An unapproved foreign product is promoted for mail-order shipment; or
3. There is repeated importation of a product that represent a health fraud.

Since issuance of these guidelines, FDA has issued a number of import alerts based on the determination that the products were promoted for sale in the United States. We noted import alerts placed on two hair-loss prevention products where FDA determined imported shipments were of commercial size. See Import Alert 66-41, Revised 8/9/95, "Unapproved New Drugs Promoted in the United States", Revised Attachment 11/4/97).

IV. Federal Appeals Court Finds FDA Health Claim Rules Unconstitutional

In a decision dated January 15, 1999, the U.S. Court of Appeals for the District of Columbia Circuit held the FDA's interpretation of its general regulation 21 C.F.R. §101.14 and the following sub-regulations invalid: 21 C.F.R. ß101.71(a), (c), (e); §101.79(c)(2)(i)(G).³ The Circuit Court sent the case back to the district court with instructions to ask FDA for an explanation of "significant scientific agreement" and for reconsideration of the plaintiffs' health claims.

The four health claims stated the following in relation to particular supplements:

1. "Consumption of antioxidant vitamins may reduce the risk of certain kinds of cancer."
2. "Consumption of fiber may reduce the risk of colorectal cancer."
3. "Consumption of omega-3 fatty acids may reduce the risk of coronary heart disease."
4. ".8 mg of folic acid in a dietary supplement is more effective in reducing the risk of neural tube defects than a lower amount in foods in common form."

FDA rejected the four claims based on its "significant scientific agreement" standard and its procedure for establishing the validity of health claims. Although the agency gave no explanation or definition of "significant," it determined that the supportive evidence was inconclusive and failed to give rise to significant scientific agreement. Specifically, the agency refused approval for the dietary fiber claims because "a supplement would contain only fiber, and there is no evidence that any specific fiber itself caused the effects that were seen in studies involving fiber-rich foods." (quotation and brackets omitted). FDA similarly rejected the claims for antioxidant vitamins and omega-3 fatty acids. The agency rejected the folic acid claim because "the scientific literature does not support the superiority of any one source over others," and it declined to consider allowing the claim with an associated disclaimer. Although FDA initially rejected a more general claim for folate, it ultimately approved the general claim⁴ for use on dietary supplement and/or food labels.

The plaintiffs challenged the agency's decisions on numerous grounds, including constitutional grounds. The Circuit Court choose to address first the argument that FDA impaired the plaintiffs' First Amendment rights by its use of the undefined significant scientific agreement standard. FDA argued that any health claim lacking significant scientific agreement is inherently misleading and, thus, not protected by the First Amendment. Furthermore, FDA stated it is not obliged to consider requiring disclaimers for health claims in place of an outright ban on all claims unsupported by significant scientific agreement.

The Circuit Court disagreed and rejected as "almost frivolous" FDA's argument that health claims lacking significant scientific agreement are inherently misleading because of the overwhelming impact they have on consumers.⁵ The Court stated that FDA's regulatory approach failed to advance its asserted interest in prohibiting the use of unapproved health claims because such action would limit consumer fraud/confusion. Relying on Supreme Court and circuit court precedent, the D.C. Circuit Court concluded that the government should not choose a policy of suppression over disclosure if the disclosure can be presented in a non-deceptive manner.

Furthermore, the court agreed with the plaintiffs that FDA had failed to provide some meaning or context for "significant scientific agreement", which violates the First and Fifth Amendments, as well as the Administrative Procedure Act (APA. After declining to address the First
Amendment argument, the court determined that the Fifth Amendment vagueness argument was on point. The court went on to conclude that the APA requires FDA to explain its rejection of health claims because the APA prohibits agencies from engaging in arbitrary and capricious acts. The court held that the agency may continue to evaluate claims on a case-by-case basis, but that the FDA must "explain what it means by significant scientific agreement or, at [a] minimum, what it does not mean."

Prepared with the assistance of Anne Begley and Beth Krewson, associates in the food and drug department of McKenna & Cuneo, LLP.

According to the Wall Street Journal (Dec. 3, 1997), Cholestin importer Pharmanex might have avoided FDA regulatory action against its Chinese medicine cholesterol lowering product, Cholestin if it had not carefully researched and publicized the elements of the herb responsible for its beneficial effects. When Pharmanex research identified lovastatin as the active element in Cholestin, FDA concluded that the actual intent of Pharmanex was to produce lovastatin, a substance already marketed in the U.S. for the same purpose as a drug,, rather than a dietary supplement.

The January 1998 Techgazette reports that pfisteria, the microorganism responsible for significant fish kills in Maryland last year, remains an enigma. Pfisteria, first discovered in the sediment of the Choptank River in 1993, is "an ancient, opportunistic dinoflagellate" that survives by changing its shape. According to researchers, Pfisteria can assume between 21 and 24 different shapes and appearances, from a "slimy, crawly" organism to knot-like appearances and life forms that are resistant to drying. One or more of these forms produces a toxin dangerous to fish. Scientists were looking for the organism when they should have been looking for traces of the toxins produced during four of pfisteria's lifeforms. This apparent example of "pleomorphism" is currently under investigation at North Carolina State University, the National Marine fisheries Lab in Charleston, SC and the and the National Institute of Environmental Health Science in Research Triangle Park, NC.

About the Author

Emalee Murphy, whose experience in FDA-regulated industries spans over 20 years, provides regulatory and enforcement counseling for clients in the drug (prescription and OTC), medical device, dietary supplement, cosmetic, food, and food additive industries, with particular emphasis on market entry issues and strategies for new products and new companies. She is experienced in FDA import and export issues and provides assistance to companies involved in FDA compliance, import detention, and enforcement matters.

References

1. The United States Federal Trade Commission ("FTC") also claims jurisdiction asserting that internet promotional material is advertising. The FTC has jurisdiction over the advertising of over-the-counter drugs and cosmetics pursuant to the Federal Trade Commission Act, § §5, 12, and 15. Although this memorandum does not address FTC activity in this area, Carilene should be aware that the FTC has been very active in reviewing internet promotional material (see our facsimile to Laboratoires Carilene dated November 20, 1997 regarding the FTC "surf day") and that product claims must be substantiated. The level of substantiation is dependent on the type of claim.
2. FDA may determine that a shipment is a commercial shipment based on the quantity (i.e., the supply exceeds what one person might take in approximately three months).
3. In so holding, the Circuit Court reversed the decision of the U.S. District Court for the District of Columbia. Pearson v. Shalala, 14 F.Supp.2d 10 (D.D.C. 1998).
4. The plaintiffs proposed the claim that consumption of folate reduces the risk of neural tube defects.
5. The court summarized FDA's argument as stating that it would be nearly impossible for consumers to exercise personal judgment in purchasing dietary supplements.

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