DIETARY SUPPLEMENT HEALTH and EDUCATION ACT of 1994

The Dietary Supplement Health and Education Act of 1994 (DSHEA) was a significant milestone in the history of food and drug law in the United States  DIETARY SUPPLEMENTS:  The overwhelming support for this legislation indicates the potential size of the market for dietary supplements. If we are to believe what we hear, the signing of DSHEA was the result of a lobbying effort which was more intense over this bill than for any other bill passed by Congress. It was passed with the virtually unanimous support of Congress. This didn't happen in a vacuum. Much intense discussion in government and industry preceded and accompanied the creation and finalization of the Act. The determination of the American people ~Congress's constituency~ actually propelled the law into being.
Stephen L DeFelice, MD, was involved early on with the discussion that framed the Act. Long before DSHEA was signed, Dr DeFelice coined and defined the marketing term "nutraceutical" to apply to a broad range of health-related products. Industry quickly adopted and widely uses Dr DeFelice's term  DSHEA created a new category of products called dietary supplements and set up a framework for regulating these products that is different in several respects from other classes of products regulated by the Federal Food and Drug Administration (FDA). Each product regulated by the FDA falls into a particular regulatory class. The product classification determines the requirements a product must meet under law. The legal classification that most of nutraceutical products fall under is "dietary supplement".  HEALTH:  The preamble to DSHEA is very interesting in that it delineates the reasoning behind Congress's decision to pass the dietary supplement law. The preamble explains that the law was passed to raise the level of health of the American people, help delay the onset of chronic disease and lower health care costs in the US. In part, Congress reasoned that:  Science has linked good nutrition and the benefits of dietary supplements with health promotion and disease prevention. Preventative health measures, including appropriate use of safe dietary supplements, will decrease disease. Prevention of disease will reduce the country's health care expenses. As a manifestation of public sentiment, the DSHEA reflected the growing interest of Americans in taking personal responsibility for their own good health and perhaps their growing disillusionment with traditional health care methods.  EDUCATION:  Food and drug law defines "label" as information on the container in which a product is sold. "Labeling" is information about the product that 'accompanies' the product. FDA scrutinizes product claims contained on labeling with essentially the same attention as product claims on actual container labels. Further more, over the years the FDA has broadened the definition of 'accompanying ' to include almost any information a company disseminates about its products, whether physically accompanying (e.g., shipped with) the product or not. So, for example, all product information distributed by pharmaceutical sales representatives to potential customers (e.g., doctors) is considered labeling.  At the extreme, even medical textbooks given by pharmaceutical representatives to doctors (potential consumers) were considered 'labeling'. Due to the fact that those textbooks, for example, contained information about the use of cancer drugs for types of cancer other than those indicated on the product label, a company was accused of making unauthorized claims for its products by means of the textbooks used as 'labeling'. So education- even education of doctors in extended uses of approved drugs- was not possible for pharmaceutical companies. Doctors are on their own to educate themselves about additional helpful uses of approved drugs.  However, where dietary supplements are concerned, DSHEA limits what regulators can define as labeling, thereby allowing more education of consumers about potentially helpful uses of dietary supplements. This is a powerfl change. When certain conditions are met, scientific papers and other categories of published information can now be used to educate consumers about our products without the danger of that material being regulated as labeling, even though such materials sometimes address uses in addition to those delineated on a container label or on the traditionally defined labeling for the products. Moreover, DSHEA makes clear that the burden of proof rests on th FDA to establish that an article or other such matter is false or misleading.  To be exempt from scrutiny as labeling, educational materials must meet certain requirements as follows. Labeling exemptions under DSHEA comprise entire articles, book chapters and official abstracts of peer-reviewed scientific publications that  Are not false or misleading Do not promote a specific brand or manufacturer Are presented with other such items on the same subject matter so as to present a balanced view of the available science Do not have any information (such as company promotional materials) attached by sticker or other method and If displayed in an establishment, are physically separate from the dietary supplements. Note that these materials must be used in their entirety. They cannot be cut apart and/or rewritten and still be acceptable for use in connection with the sale of dietary supplements to consumers.  In 1994, Congress acknowledged in DSHEA that 50% of Americans already used dietary supplements and more than $4 billion was being spent annually on these products. This was true even before passage of the law and the market is growing. It therefore doesn't make much sense to stand in the way of consumer education about products they are already using. However, that education must be done in a truthful non-misleading and balanced way, as delineated in DSHEA.  THE EVOLVING REGULATIONS:  When DSHEA was signed by the President in October of 1994, it became law. Once a new law is signed, however, the regulating agencies (in this case, the FDA) must create regulations describing how they will enforce the law. Until those regulations are completed, industry must do its best to pick its way around the sinkholes in a foggy landscape. Described below are a few areas that are still not final as far as regulations of dietary supplements are concerned.  The DSHEA mandated that a panel be appointed by the President to review the issue of appropriate claims for dietary supplements and submit a report containing recommendations within two years-by October 1996. . The FDA was then to initiate rule making based on the panel's recommendations. The panel, however, was not appointed until almost a year after DSHEA was signed and as of this writing, is still deliberating. They are now projecting that their report will be ready by the end of April 1997.  When the report is issued we will have a good idea of the types of claims that will be allowable or not allowable in the future. However, FDA has two years to complete rule-making after receipt of the report. So no change can be expected in the types of claims we can make any time soon.  In addition to the issues concerning claims DSHEA mandated that the FDA initiate rule-making to establish Good Manufacturing Practices (GMP's) for dietary supplements based on the existing GMP's for food products.   FDA was also mandated by DSHEA to develop regulation on how ingredients should be listed on dietary supplement labels and how 'supplements facts" boxes should be completed (similar to "nutrition facts" boxes on foods). These final regulations are due out any day. Once they are issued, dietary supplement companies will have at least a year to bring their labels in compliance.   WATCHING FOR THE SINKHOLES:  While the above discussed areas remain foggy for dietary supplements, one area of compliance is, at this time, as clear as a mountain morning. Dietary supplements are foods intended to promote optimal health. They are not drugs for which claims can be made to diagnose, treat, mitigate or cure any type of disease or compromised condition.  Two dangers exist in the area of claims for dietary supplements. First, the danger exists that if a drug claim were made for a product, the FDA could choose to regulate that product as a drug. The greater freedoms granted dietary supplements under DSHEA would be, thereby , forfeited for that product. Since our products don't meet drug standards-for example Phase III clinical trials have not been conducted- the product could b considered an unapproved, new drug and removed from the market. Thus, drug claims made for dietary supplements are very serious.  A second danger n the area of drug claims for dietary supplements falls in the area of 'secondary health hazards". Even though a product is safe, drug-type claims could cause someone to discontinue use of proven drug therapy and thereby cause their condition to worsen. This could result in even a very safe product being considered a 'secondary health hazard" and treated as such. As we would expect, both the FDA and various state Departments of Health consider such things very serious.  In the area of claims, or more correctly 'statements'. for dietary supplements the words we choose are critical. Does cranberry juice cure bladder infections (a drug claim) or does it promote a healthy urinary tract (a dietary supplement statement)? It may look the same to you and me, but to the FDA, it makes the difference as to whether that product is regulated as a drug or a food. Careful thought must always be given to wording of statements about our products. Statements for dietary supplements talk about health and health maintenance. Claims for drugs talk about reversing a diseased condition. These types of claims should be avoided.  THE OPPORTUNITY:  As a manifestation of public sentiment, passage of DSHEA illustrates the tremendous interest in and therefore, the tremendous market for good dietary supplements. As North Americans become more and more interested in taking responsibility for their own health, the market for dietary supplements will continue to grow.