Review of FDA's Current Good Manufacturing Practices for Dietary Supplements Regulations, Dealing with Herbal-Botanical Substances, and the Global Scope of Industry

The CGMPs require that proper controls are in place for dietary supplements manufacture so that they are processed in a consistent manner and produce a high quality product that is not adulterated with contaminants or impurities, and are accurately labeled to reflect the ingredients intended to be in the product. Some problems the CGMPs would help prevent are inclusion of the wrong ingredients, too much or too little of a dietary ingredient, contamination (e.g. natural toxins, bacteria, pesticides, glass, and heavy metals such as lead), and improper packaging and labeling.

The final DS CGMP rule does not apply to raw ingredient manufacturers, although they will continue to need to meet the food CGMP regulations. This makes the finished manufacturer responsible for the dietary ingredients it uses. The final CGMPs provide clear expectations in manufacturing, packaging, labeling, and holding operations for dietary supplements. If dietary supplements do not contain the dietary ingredient they are represented to contain, FDA would consider those products to be adulterated or misbranded and the agency would consider its enforcement options. The increased use of herbal and other botanical substances in dietary supplements presents unique challenges, especially in the analytical arena, where existing methods for identification and analyses may be optical recognition, microscopic, organoleptic, or some other subjective method rather than the orderly chemical analyses conducted for other substances. These special products will be discussed. Globalization of the dietary supplement industry, especially in the area of dietary ingredient production is a reality that we all must face. A large percentage of our dietary ingredients are imported. International considerations are a major part of our planning, though new international agreements between the US and some foreign governments may give us some additional confidence in products entering our country. Nevertheless, we expect our attention to products from foreign sources to consume many of our resources in implementing this rule.