This legislation has been the focus of intense debate and consumer concern since new regulation for "health claims" for dietary supplements including herbs under the Nutrition Labeling and Education Act of 1990 (NLEA) became an issue several years ago. Since then, Congress has received more mail on this subject than any other issue, including Bosnia, the Gulf War, Somalia, gun control, tax reform, and healthcare reform!

The Act pertains to a broad class of products used by the public as dietary supplements. Supporters of the legislation claimed a major victory in the passage of the bill. This includes the herb and phytomedicine community, manufacturers of vitamins and other supplements, the wholesalers and retailers of these products and various consumer groups.

The new bill includes these findings:

- "There is a link between ingestion of certain nutrients or dietary supplements and the prevention of chronic diseases such as cancer, heart disease, and osteoporosis."

- "Studies indicate that consumers are placing increased reliance on the use of non-traditional healthcare providers to avoid the excessive costs of traditional [sic; we think this should be termed `conventional' -- Ed.] medical services and to obtain more holistic consideration of their needs."

- "The nutritional supplement industry is an integral part of the economy of the United States."

- "Although the Federal Government should take swift action against products that are unsafe or adulterated, the Federal Government should not take any actions to impose unreasonable regulatory barriers limiting or slowing the flow of safe products and accurate information to consumers."

ESSENTIAL ELEMENTS OF THE BILL with emphasis on how it may affect the marketing and sale of herbal products:

Definition of dietary supplement. Section 3 of the new law creates, for the first time, a legal definition of dietary supplements which includes vitamins, minerals, herbs or other botanicals, amino acids, and other "dietary substance for use by man [sic] to supplement the diet by increasing total dietary intake," including "a concentrate, metabolite, constituent, extract, or combination" of these ingredients.

Section 3 also holds that where an ingredient is first marketed as a dietary supplement and is later approved as a new drug, it can continue to be sold as a supplement unless the Secretary of Health and Human Services (HHS) rules that it is unsafe to do so. The significance of this is that sometimes an ingredient may be sold as a supplement and later a company might want to apply for a new drug application to market the substance as a drug. If such approval is later granted, this would not prohibit the ingredient from being marketed as a dietary supplement so long as it was still deemed to be safe under the conditions of use set out on the product label.

Exclusion from Food Additive Status. Section 3 prohibits the Food and Drug Administration (FDA) from regulating herbs and dietary supplements as food additives. The industry has been concerned about this issue for years: FDA has tried to argue that some dietary ingredients are food additives and therefore require pre-market approval. Industry considers its products to be foods, not food additives, and has felt that FDA has misused its authority by attempting to regulate some ingredients as such. Several federal courts have agreed with industry, as exemplified in the Black Currant Oil case;(1,2) apparently, Congress agrees.

Safety Burden of Proof on FDA. In an important clarification of the law, Section 4 now confirms that the burden of proof that a product is adulterated or unsafe rests on the FDA. A new safety standard has been developed whereby a product which presents a significant or unreasonable risk of illness or injury under the conditions of use on the label will be deemed unsafe. This bill also grants the Secretary of HHS emergency powers to remove a supplement from the market if it is deemed to pose an imminent hazard to health. However, the government must then promptly convene proceedings to review the evidence justifying such action.

Dietary Supplement Claims. Section 5 permits, for the first time, information from books and scientific literature to be used in connection with the sale of dietary supplements. This is permitted so long as the information is not false or misleading, does not promote a particular manufacturer or brand, presents a balanced view of the scientific information, is physically separated from supplements if displayed in a retail store, and does not have any other information appended to it. The literature must be presented in its entirety unless it is an abstract of a peer-reviewed scientific publication prepared by the author or editors of that publication. The bill also allows retailers to continue to sell books and publications as part of their normal business. The FDA would bear the burden of proof that such literature or information is false and misleading.

Some questions arise from this provision, i.e., who will decide what is "false and misleading" and what is a "balanced view"? This point might become a basis for future contention among various parties having interests in science, nutrition, regulation, and industry.

Statements of Nutritional Support. Section 6 allows claims regarding a dietary supplement's effect on the structure or function of the body or general well-being. To make such a claim a manufacturer must be able to substantiate that the claim is truthful and not misleading and must notify the Secretary of HHS no later than 30 days after first marketing such claims. The label must include the following disclaimer: "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease." (This disclaimer is highly reminiscent of a similar one required of herbal products sold as Traditional Medicine in France.) Finally, therapeutic claims, e.g., claims that deal with treating symptoms or diseases, are not allowed. In passing this provision, it is not clear how distinctions will be made between structure and function claims on the one hand, and health claims on the other. In this section, the supplement industry accepted a compromise, backing off from its previous position in which it wanted more liberal criteria for approval of health claims as set out by NLEA. It was the issue of how to approve health claims and what standard would be employed that started much of the legislative initiative three years ago, after FDA issued proposed rules to implement NLEA, which the supplement industry, particularly the herbal interests, perceived to be contrary to not only industry interests but also to Congressional intent.

New Labeling Requirements. Section 7 requires that the term "dietary supplement" appear on the label of such products and that each ingredient be labeled by name and quantity. Statements or representations of quality standards including purity, disintegration, and composition are also addressed. This section also amends the nutrition labeling and nutrient content claims under final regulations issued pursuant to the NLEA. The tion granted to vitamins and minerals in section 411 of the FDCA (the Proxmire amendment passed in 1976) are extended to all dietary supplement, assuring that these substances cannot be treated as drugs by FDA solely due to their potency or combinations.

New Dietary Ingredients. Section 8 addresses the sale of new dietary ingredients present in the food supply as an article of food in a chemically unaltered form. FDA can consider a new dietary ingredient unsafe if it is sold in a form that is chemically altered from the form as found in the food supply unless the manufacturer notifies the agency 75 days prior to introduction of the ingredient. Such notice must include the information upon which the manufacturer has relied to conclude that the substance is safe, including any references to published articles on the ingredient. FDA will keep such information for 90 days and then make it available to the public unless it is confidential. A manufacturer can also petition FDA to issue a regulation prescribing the conditions under which a new ingredient can be safely marketed, in which case FDA has 180 days to respond. New dietary ingredients will now be defined as those that are first marketed after October 15, 1994.

Good Manufacturing Practices (GMPs). Section 9 provides that the Secretary of HHS can issue regulations prescribing GMPs for dietary supplements which will be based on food GMPs, not drug GMPs. This includes the possible requirement of expiration dates on supplements where this is deemed to be necessary. This issue deals with concerns expressed over the past few years that FDA might require supplement manufacturers to conform to the much more stringent and costly GMPs required for drugs.

Conforming Amendments. Section 10 ensures that a product will not be treated as a drug if statements of nutritional support, warnings, and directions for conditions of use are included on the label. For example, in the recent past, FDA has issued warning letters to supplement manufacturers for simply providing a recommended dosage range on a bottle of garlic pills; FDA claimed that the product was misbranded because the use of the term dosage implied therapeutic activity of the product. Also, some manufacturers were fearful that putting responsible warning labels on some herbal products might create a situation in which FDA would regulate the product as a drug, since food products do not generally contain warnings.

Withdrawal of Regulation. Section 11 requires that the Secretary of HHS declare null and void the advance notice of proposed rulemaking (ANPR)(3) issued June 18, 1993 (based on the so-called "Dykstra Report"(4)). regarding FDA's views about the use of dietary supplements and proposed methods for their regulation which included potential drug status for high potency vitamins and other ingredients if FDA deemed that they were being sold with an intended therapeutic use.

Commission on Dietary Supplement Labels. Section 12 provides for the establishment of a seven-member Presidential commission which will conduct a two-year study and issue a report with its findings on the regulation of label claims and statements for supplements, and the evaluation of these claims, including the use of literature employed in connection with the sale of supplements. This commission will consist of unbiased persons who have expertise in supplement manufacture, regulation, and usage. A key point for those interested in herbal matof the members of this commission must have expertise in the area of "pharmacognosy, medical botany, traditional herbal medicine or other related sciences." Upon issuance of the commission's report, the Secretary of HHS has two more years to issue regulations on the report. If no regulations are issued, the current regulations on health claims for dietary supplements will expire. In the meantime, no health claims are allowed unless an autho rizing regulation is issued for such claims.

Office of Dietary Supplements. Finally, Section 13 authorizes $5 million to establish the Office of Dietary Supplements at the NIH to collect, compile, conduct and coordinate scientific research on dietary supplements. This office will act as the principal advisor on supplements to the Secretary of HHS, NIH, Center for Disease Control (CDC), and FDA. This important provision, according to sponsors of the legislation, will now focus research on dietary supplements in an area where more open minds may prevail. Sponsors of this legislation and other critics of FDA are of the opinion that FDA has an institutional bias against supplements in general and that although FDA still has the authority to regulate them, the establishment of this new office at NIH will allow for much forward progress in the area of scientific research and government policy supporting the use of dietary supplements in health promotion.

FDA has the responsibility to issue regulations implementing certain provisions of the new law. Historically, the agency has interpreted such legislation narrowly. Interested parties on all sides of this issue will probably watch FDA at every step of this rulemaking process to ensure that the new regulations will reflect the intent of Congress and the American people.

References:

(1.) United States v. Two Plastic Drums, 984 F. 2d 814, 817 (7th Cir. 1993).

(2.) Blumenthal, M. 1993. Firm Wins Appeal in Black Currant Oil Case. HerbalGram #29 pp. 38-39.

(3.) Advance Notice of Proposed Rulemaking. 21 CFR Ch. I [Docket 93 N-0178] RIN 0905-AD90. Regulation of Dietary Supplements. Federal Register 58: 33690-33700.

(4.) Dietary Supplement Task Force Report. Food and Drug Administration, June 15, 1993.

Article copyright American Botanical Council.

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By Mark Blumenthal