U.S. Food and Drug Administration
Performance Plan
2002
Provide consumers with a high level of confidence in the safety, composition, and labeling of dietary supplement products.
| Review 95 % of notifications for dietary supplements containing "new ingredients" within 75 days. |
Dietary supplements are estimated to be over a $17 billion a year business, and it's booming as consumers search for a fast fix - an easy way to feel better and stay healthy. The dietary supplement industry is one of the fastest growing industries in the world. Surveys show that over half of the US population now uses some type of dietary supplement and FDA estimates that the industry markets approximately 29,000 of these products which are sold under 75,000 distinct labels.
Just as consumption has grown, access also to dietary supplements has changed. In the past, except for vitamin and mineral products, dietary supplements were available mainly in health food stores and were principally marketed to adults. Now products are available through supermarket, other retail stores, mail order, TV programs, and via the Internet. This makes dietary supplements readily available to children and adolescents, as well as adults. This presents new regulatory challenges.
Dietary supplements include vitamins, minerals, herbs, and amino acids as well as substances such as enzymes, organ tissues, metabolites, extracts or concentrates. Dietary supplements can be found in many forms such as pills, tablets, capsules, liquids, or powders. They must be identified as a dietary supplements on the label.
Federal law requires manufacturers of dietary supplements to ensure that the products they put on the market are safe. Except for new dietary supplements, FDA review of supplement ingredients and products is not required before marketing. Under the 1994 Dietary Supplement Health and Education Act (DSHEA), once a dietary supplement is marketed, FDA has the responsibility for showing that the product is unsafe before it can take action to restrict the product's use.
The growing market for supplements, in a less restrictive regulatory environment, creates the potential for supplements to be prone to quality control problems. For example, FDA has identified several manufacturers who were buying herbs, plants and other ingredients without first adequately testing them to determine whether the product they received was what they ordered, and whether it was free from contaminants. FDA is working to provide a high level of confidence in the safety of dietary supplements.
FDA must take a proactive approach in determining and monitoring the safety of dietary supplements, as opposed to merely reacting to crises. FDA has developed a Dietary Supplement Ten-Year Plan to position itself to respond to these challenges. The strategy can be accelerated or decelerated, depending on resource availability and safety concerns.
The dietary supplement industry is predicted to grow at a rate of 12 to 14 % annually. To keep pace, FDA must focus on the scientific review of new dietary supplement products. FDA must review within 75 days the petitioner notification on any new ingredient that will be part of a dietary supplement. Dietary supplement manufacturers that wish to market a new ingredient that was not marketed in the U.S. before 1994 have two options. The first involves submitting to FDA at least 75 days before the product is expected to go on the market, information that supports their conclusion that a new ingredient can reasonably be expected to be safe. - Another option is to petition FDA to establish conditions under which the new dietary ingredient would reasonably be expected to be safe.
DSHEA gives FDA the authority to establish good manufacturing practices (GMPs) regulations governing the preparation, packing, and holding of dietary supplements under conditions that ensure their safety.
FDA oversees safety, manufacturing, and product information, such as claims in a products labeling, package inserts, and accompanying literature. To protect the public health, FDA must have a strong system to monitor products once they are on the market and in daily use.
While there are some likely benefits from the use of some of dietary supplement products, without a visible FDA regulatory presence, the potential for exaggerated claims, unpredictable composition, and toxicity are of considerable concern. There is also a real and growing concern about interactions between dietary supplements and over-the-counter and prescription medications.
FDA anticipates that notifications for dietary supplements containing "new ingredients" will become increasingly more complex, and that the volume of such notifications submitted to FDA will increase.
The passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA) greatly expanded the marketing opportunities for dietary supplements. Subsequent to enactment, the marketplace has grown significantly.
To effectively regulate this marketplace FDA needs: (1) to address the large number of safety and quality issues presented by the large increase in the numbers and variety of products in the marketplace; (2) an effective Adverse Event Reporting System to enable all adverse event reports to be evaluated in a timely fashion; (3) effective inspectional oversight of domestic manufacturers and imported products; and (4) to take effective enforcement action against adulterated and/or misbranded products.
When Congress passed DSHEA, it created a regulatory framework for dietary supplements that previously did not exist. The purpose of the framework was to strike the right balance between providing consumers access to both products and truthful information about the products while retaining authority for FDA to take actions against products that present safety problems or are improperly labeled. We are now being engaged in the difficult task of delineating boundaries between drugs, dietary supplements, and conventional foods. The definition of supplement is broad, but it must not allow the inclusion of ingredients never intended to fit within the universe of dietary supplements. Now, products that contain substances similar to those found in prescription drugs are marketed for children as dietary supplements. Likewise, products with ingredients that simulate illicit street drugs are marketed as dietary supplements to adolescents via the Internet and shops specializing in drug paraphernalia. FDA is working toward a solution that will be consistent with the intent of DSHEA.
Since FY 1998, FDA has exceeded its dietary supplement premarket performance goal by reviewing 100% of all notifications for dietary supplements containing "new ingredients" within 75 days.