SUMMARY:

THE DIETARY SUPPLEMENT AND HEALTH AND EDUCATION ACT OF 1994

1. Title of the Act (Section1). This new law is cited as the Dietary Supplement Health and Education Act of 1994.

Citizens For Health Note: This Act will be abbreviated as the DSHEA or as the "Act." It has also been referred to as the "Hatch/Harkin/Richardson bill." An Act is a bill which has been passed by Congress and signed by the President.

2. Findings. The Congress states its purpose in passing the Act and notes the following key points:

• Improving the health of the U.S. citizenry is a top national priority.
  
• Dietary supplements have been shown to be useful in preventing chronic disease, and their appropriate use will help limit the incidence of chronic disease and long-term health care costs.
  
• Consumers should be empowered to make informed choices about preventative healthcare programs based on scientific studies relating to dietary supplements.
  
• Almost 50% of Americans use dietary supplements to improve their nutrition.
  
• Consumers are placing greater reliance on nontraditional healthcare providers due to the high cost of traditional medical services.
  
• 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 (but should take swift action against unsafe products).
  
• Dietary supplements are safe within a broad range of intake, and safety problems with dietary supplements are relatively rare.
  
• Legislative action is necessary to protect the consumers' right of access to safe dietary supplements to promote wellness.
  
• A rational federal framework must be established to supersede the current ad hoc, patchwork regulatory policy on dietary supplements.

  Citizens for Health Note: These findings of Congress are an outstanding summary of the compelling need to reform FDA policy and practices with regard to dietary supplements and to actively promoter the role of supplements in health and wellness.

3. Definition of Dietary Supplement (Section 3). The term "dietary supplement" now means a product (other than tobacco) intended to supplement the diet which contains one or more of the following dietary ingredients:

Vitamins, minerals, herbs or other botanicals; amino acids; a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract or combination of any of these ingredients.

• are in a dosage form such as capsules, tablets, liquids, powders, soft gels, etc., and which;
  
• are not represented as a conventional food or as a sole item of a meal or of the diet, and which;
  
• are labeled as a dietary supplement.

• Substances first sold as a drug and then later as a dietary supplement; or
  
• Substances undergoing substantial and publicly announced clinical studies as an investigational new drug which were not sold as a dietary supplement before the date announcing the existence of these clinical trials.

Citizens For Health Note: Dietary supplements are now a broad and legally defined class of substances. Supplements and drugs are also distinguished on a "first-to-the-market" policy in certain special circumstances, in order to balance the need for incentives to conduct drug research against the broadest possible access to substances which can safely be sold as dietary supplements. There was deep concern among some members fo Congress that drugs could be masqueraded as dietary supplements under this broad definition. As a result, this complex language was drafted to determine the difference between a dietary supplement and a new drug.

4. Exclusion from Definition of Food Additive (Section 3(b)). Dietary supplements as now defined are explicitly excluded from the definition of food additive.

Citizens For Health Note: Food additives are chemicals added to foods to preserve, emulsify, stabilize, or perform a range of other technical functions. Such chemicals require FDA premarket approval before use in foods. FDA has asserted that dietary supplements are food additives and has tried to force certain products off the market using this theory. This practice is now expressly prohibited. This includes single or combination dietary supplement products.

5. Safety of Dietary Supplements and Burden of Proof on FDA (Section 4). A dietary supplement will be considered unsafe if:

• It presents a significant or unreasonable risk of illness or injury under the conditions of use recommended or suggested on the label or labelling (or the ordinary conditions of un\se if there are no label instructions); or
  
• It is unsafe under Section 402(a)(1) under the conditions of use on the label or labeling of the product.

The Secretary of Health and Human Services (Secretary) may declare a dietary supplement to be an imminent hazard to public health or safety and suspend sale of the product. This authority cannot be given to FDA, and the Secretary must promptly initiate on-the-record rule making to affirm or withdraw this declaration.

In any case where FDA asserts that a dietary supplement is unsafe, the Agency bears the burden of proving that the supplement is, indeed, unsafe. Any court that hears a case under this provision will decide all issues on the de novo (fresh look) basis. Also, before FDA can begin a civil proceeding against a dietary supplement (such as a seizure), it must provide 10-days notice to the person or company it intends to move against and give them an opportunity to present their views.

Citizens For Health Note: This section creates a new safety standard unique to dietary supplements. The existing safety standard for foods may also be used by FDA Section 402, but again based on the label conditions of use. It is now permissible to put cautions, warnings, and specific dosage recommendations on supplement labels for groups or individuals at risk (pregnant women, small children, those with allergies.) The Secretary can declare an imminent hazard to remove a supplement from the market if there is a major safety issue such as contaminated L-tryptophane. Promptly after this, formal rule making must begin to fully investigate the issues to determine what caused the problem.

6. Dietary Supplement Claims and Labeling Exemptions (Section 5). A publication, including an article, a chapter in a book, or an official abstract of a peer reviewed scientific publication that appears in an article and was prepared by the author or the editors of the publication, which is reprinted in its entirety, is not labeling when used in connection with the sale of a dietary supplement to consumers when it:

• Is not false or misleading;
  
• Does not promote a particular manufacturer or brand of dietary supplement;
  
• Is displayed or presented with other items on the same subject so as to present a balanced view of the available scientific information on the dietary supplement;
  
• if displayed in an establishment, it is physically separate from the dietary supplements;
  
• Does not have appended to it any information by sticker or other method.

This section does not restrict a retailer or wholesaler of dietary supplements from selling books or other publications as part of their business.

In any proceeding brought by FDA under this section, the Agency has the burden of proof to establish that an article or other such information is false or misleading.

Citizens For Health Note: This section is known as the "third Party Literature" provision. This is an exemption from the basic rule that information used to sell a dietary supplement is labeling when provided by a manufacturer, distributor or in many cases a retailer. Such labeling when used to sell dietary supplements renders the product a misbranded drug. Now, this class of information may be used to sell dietary supplements if the five conditions are met.

7. Statements of Nutritional Support (Section 6). A statement on the label or labeling of a dietary supplement may be made if the statement:

• Claims a benefit related to a classical nutrient deficiency disease and discloses the prevalence of that disease in the U.S.; or
  
• Describes the role of a nutrient or dietary ingredient which is intended to affect the structure or function of the body; or
  
• Characterizes the documented mechanism by which a nutrient or dietary ingredient acts to maintain a bodily structure or function; or
  
• Describes general well-being from consuming a nutrient or dietary ingredient.

Dietary supplements which make such a statement must also prominently display in bold faced type 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."

Citizens For Health Note: This section is known as the "Structure/Function" provision. Manufacturers must have adequate substantiation (the degree of adequacy is not defined) that the statement is truthful. The required disclaimer is intended to distinguish these products from approved drug products. The class of claims that are contemplated under this section deal with how nutrients and dietary ingredients help support or assist bodily functions or structure but which are not intended to specifically treat disease states.

8. Dietary Supplement Ingredient Labeling and Nutrition Information. Dietary supplement labels must include the following information or they will be considered misbranded:

• The name of each ingredient in the product.
  
• The quantity of each ingredient.
  
• The total weight of those ingredients (if it is a proprietary blend or formula).
  
• The identity of any part of the plant from which a botanical ingredient is derived.
  
• The term "dietary supplement".

Citizens For Health Note: This in the "honest label section." It will help consumers make more informed choices among various products. DIetary supplement labels must actually bear the term "dietary supplement" in order to be treated as such under this Act.

9. Nutrition Labeling. The Secretary must issue new regulations to establish a format for listing dietary ingredients on supplement labels. Supplement labels will be required to declare the amount of a substance that is now required for the Nutrition Facts panel on conventional foods, but only if present in the product in a significant amount. The quantity of each ingredient must be listed and the source of the ingredient may be listed.

Citizens For Health Note: This amends the nutrition labeling regulation scheduled to take effect July 1, 1994 which would have forced many dietary supplement labels to use the conventional food nutrition facts panel. This is now greatly simplified, and unnecessary and useless requirements have been eliminated.

10. Percentage Level Claims. The Nutrient Content Claim regulations are amended to permit statements on dietary supplement labels that characterize the percentage of level of a dietary ingredient so long as the FDA has not established a reference daily intake, a daily recommended value or other recommendation for daily consumption.

11. Section 411. Section 411, (The Prozmire Amendment) is amended to include not only vitamins or minerals, but all dietary ingredients as now defined.

12. New Dietary Ingredients (Section 8). A dietary supplement sold after October 15, 1994 which is or contains an ingredient not marketed before that date is a new dietary ingredient and will be considered unsafe unless;

• It has been in the food supply as a food in a form in which the food has not been chemically altered. Such products may be sold without notice to FDA.
  
• It does not qualify as a non chemically altered food but for which there is a history of use or other evidence of safely showing that the ingredient is reasonably expected to be safe under the conditions of use, then the manufacturer must provide the Secretary, 75 days before selling the product, with information establishing the basis on which the dietary supplement is reasonable expected to be safe. This information will be held confidential for 90 days and then made available to the public unless it is deemed proprietary. Any person may also petition GFA for an order (regulation) allowing the sale of an ingredient.

Citizens For Health Note: The Congress has essentially grandfathered all dietary ingredients sold befor October 15, 1994. The legislative history for this Act states:
"Chemically altered does not include the following physical modifications: Minor loss of volatile components, Dehydration, Lyophilization, milling, tincture, or solution in water, slurry powder, or solid in suspension."

Citizens For Health Note: This further clarifies the food status of dietary supplements, as FDA may not use drug standards to establish GMP's for dietary supplements.

14. Withdrawal of the Advance Notice of Proposed Rule Making (ANPR) (Section 11). THe ANPR concerning dietary supplements is declared null and void and of no effect with a notice to be published in the Federal Register so stating.

Citizens For Health Note: This is the "Dykstra Report" in which FDA stated its views that amino acids are not generally recognized as safe, that any herbs are really drugs and upper daily intake limits for most vitamins and minerals may be appropriate.

15. Commission on Dietary Supplement Labels (Section 12). An independent agency within the Executive Branch will be established to study and provide recommendations for the regulation of dietary supplement label claims and statements including literature used in connection with the sale of dietary supplements. The commission is to evaluate how best to provide consumers with true and scientifically valid information so they can make informed and appropriate health care choice. The commission shall have seven members with expertise in the manufacture, regulation and use of dietary supplements. Three members must also be qualified to evaluate the health benefits of dietary supplements, and one of these three shall have expertise in medicinal plants. Members and staff shall be without bias on the issue of dietary supplements. The commission will have broad administrative powers to hold hearings and collect information. Two years after enactment of this Act, the commission shall submit to the President and the Congress a final report with recommendation as the commission deems appropriate. The Secretary must publish in the Federal Register any proposed changes to FDA's regulations concerning dietary supplements. Any required rule making shall be completed within two years of the commission's report or the final regualtions on health claims for dietary supplements will be voided.

16. Office of Dietary Supplements (Section 13). An Office of Dietary Supplements (ODS) shall be established within the National Institutes of Health (NIH). The purpose of the ODS is to explore the role of dietary supplements to improve health, to promote scientific study of the benefits of dietary supplements, to maintain health and prevent disease. The Director of the ODS is to conduct and coordinate research on dietary supplements and diseases and to act as an advisor to the Secretary of HHS, the Director of the NIH, the Director of the Centers for Disease Control and Prevention CDC0 and the Commissioner of FDA with regard to dietary supplement regulations, safety and claims.