January 30, 1998

Documents Management Branch
Food and Drug Administration
Room 1-23
12420 Parklawn Drive
Rockville, MD 20857

Dear Sir or Madam:

The National Consumers League is a national nonprofit consumer organization that has represented consumers and workers in the marketplace and workplace for nearly 100 years. Assuring that consumers can purchase safe and effective medications and dietary supplements is of primary concern to our organization.

As consumers assume greater responsibility for their own health, and as more dietary supplements become available to help maintain a healthy lifestyle, consumers must be assured that such dietary supplements are safe, effective, and truthfully labeled. While the National Consumers League (NCL) applauds FDA's efforts in this area; similar to FDA, we are concerned about recent developments regarding Cholestin™.

NCL does not intend to comment on the product-specific aspects of Cholestin™--whether it contains a drug (lovastatin) or not, and the differences, if any, between lovastatin and mevinolin, those comments should come from scientists. We will focus on the questions of safety and efficacy. We will also comment on the important possible implications that this ruling may have on further statutory interpretation of provisions of the Dietary Supplement Health and Education Act (DSHEA), and FDA's policies under that statute.

The safety and efficacy of health-related products is the Food and Drug Administration's primary concern. The best way to ensure safety and efficacy is through rigorous scientific testing. NCL is concerned that Pharmanex is relying on data from limited studies, including one unpublished U.S. study, to support its claims. While NCL does not intend to belittle the efforts or merit of these studies, we simply feel that they do not meet the rigorous methods that should be employed before a product is available to consumers. We also believe that these studies and the results should undergo peer review by qualified scientists and that standard scientific methodologies be followed. NCL recognizes that the safety of Cholestin™ has not been at issue; however, consumers have a right to know that the products they are taking have been tested and are safe and effective.

Labels are the means by which a consumer learns about intended uses, ingredients, warnings, and other product information. The consumer relies on this information to be truthful and accurate in order to make informed and rational choices.

As consumers begin to take more responsibility for their own health care, it is important that product labels clearly indicate intended usage, active ingredients, warnings, and possible side effects. Since many consumers may take dietary supplements as an alternative or in addition to traditional medical treatments, it is imperative that product labels tell consumers to consult with their physician or pharmacist before taking the product. We applaud FDA's current efforts to protect consumers with regard to the labeling issue.¹ Product labeling should not bypass or blur the lines regarding FDA's rules for drug/health claims and/or structure/function claims.

The FDA concludes that Cholestin is a drug, in part, because its labeling implies that the product is intended to cure, mitigate, or treat a disease. Serum cholesterol is specifically cited by FDA as a biological parameter which the FDA considers to fall within the definition of a disease or health-related condition for purposes of health claims for food and dietary supplements because it relates to the risk of coronary heart disease.² Congress further established that any claims that could be made--implicit or explicit--that related to a disease or health-related condition were to be governed by the health claims provisions of Section 21 U.S.C. § 343(r)(1)(B) as established by the Nutrition Labeling Education Act (NLEA) and not by the structure/function provisions later established by DSHEA and codified at 21 U.S.C.§ 343(r)(6)(A). Under the NLEA, Congress permitted health claims for foods and dietary supplements that "characterize the relationship of any nutrient...to a disease or health-related condition," so long as the FDA has approved the claim pursuant to a rulemaking proceeding.³ Pharmanex has not sought approval under this provision by the FDA, and therefore, should be considered to be making an unapproved drug claim based on the following label claims:

• Maintains Healthy Cholesterol

• Reduces Total Cholesterol

• Reduces LDL "Bad" Cholesterol

• Reduces Triglycerides

• Increases HDL "Good" Cholesterol.⁴

Changing the label to read, "Maintains or Promotes Healthy Cholesterol" does not change the implied intent of the product, and may encourage individuals to take the product without first consulting with a physician about their cholesterol levels.

The lines between the necessary approval requirements of food, dietary supplements, and drugs as they relate to medical and health claims are not clear. FDA has established precedent regarding allowable health claims and structure or function claims, and the difference between the two, however, NCL feels that further clarification is necessary. This issue needs to be revisited and the language needs to be more clear and explicit in explaining the differences between structure/function and drug/health claims. The line between an unapproved, implied health claim and a legitimate structure or function claim is extremely thin. A perfect example is the case of cranberry juice and its effects on the urinary tract . It is clear that the claim "prevents the recurrence of urinary tract infections" is a disease prevention claim, and, as such, falls under the drug definition for that product. The claim, "cranberry products help to maintain urinary tract health" is permissible as a structure function claim since no disease is mentioned explicitly or implicitly

NCL supports more stringent regulation and oversight of the dietary supplement industry. On the regulatory spectrum, dietary supplements should fall between food and drugs with regard to making any health claims. If foods must obtain Significant Scientific Agreement (SSA) before health claims can be made, then dietary supplements should meet and exceed this same requirement.

NCL supports the FDA's efforts to encourage sound scientific research and good manufacturing processes, whether for drugs or dietary supplements. NCL further supports FDA's efforts to ensure safety and efficacy of all products before they are marketed to consumers, and its efforts to assure truthful health and nutrition claims, and accurate and truthful product labeling. These efforts enable consumers to make better informed health care decisions.

NCL hopes that companies would not want to bypass FDA regulatory processes, thus, avoiding the scrutiny and costs of the drug approval process, simply by labeling a product a dietary supplement, nor do we want the intent of DSHEA and NLEA to be eroded.

Dietary supplements that can be proven safe and effective have a legitimate place in the health-care marketplace, however, product labeling must make accurate claims that relate to the structure or function or the human body. Unapproved drug claims, whether implicit or explicit, made by a dietary supplement manufacturer are improper under the law (NLEA and DSHEA). Unapproved drug claims by dietary supplements may encourage consumers to seek to prevent or treat a health condition or disease without proper medical supervision. This outcome may be harmful to consumers.

Respectfully Submitted,

LINDA F. GOLODNER

President

BRETT KAY

Program Associate, Health Policy

² 58 Fed. Reg. 2478, 2482 (Jan. 6, 1993) (Food Labeling; General Requirements for Health Claims for Food, Final Rule).

³ FDCA § 403 (r)(I)(B), 21 U.S.C. § 343(r)(I)(B) .

⁴ Source: Cholestin label.

⁵ 62 Fed. Reg. 49, 859, 49, 860-61 (Sept. 23, 1997) (emphasis added).