In 1994 Congress passed the Dietary Supplement Health and Education Act (DSHEA), which required the Food and Drug Administration (FDA) to develop Good Manufacturing Practice (GMP) regulations for dietary supplement manufacturers. Thirteen years later, with substantial input from the industry itself, the FDA has finally issued these regulations.

Good Manufacturing Practices (GMPs) are just what they imply. They set forth the guidelines that all manufacturers must follow and include standards for record keeping, sanitation, testing, quality control and documentation. This ensures the quality, strength and purity of the products that companies like Schiff® sell.

Up until now dietary supplements fell under the existing GMP regulations for the food industry. Although some media reports have suggested that the dietary supplement industry has been largely unregulated, in reality it’s been regulated in much the same way as the food manufacturing industry.

However, since most dietary supplements come in tablet or capsule form, they’re manufactured more like drugs than food. In fact, the equipment that Schiff® uses to produce its supplements is comparable to that of many drug manufacturers. The new GMPs issued by the FDA borrow heavily from the drug GMPs. And while these rigorous requirements will certainly improve industry operations and products overall, it’s important to note that these are the minimum requirements for ensuring that products meet their claims.

Of course, Schiff® fully intends to comply with the new standards set forth by the FDA’s new GMPs within the required timeframes. Our procedures already meet many of the new requirements and have done so for years. In fact, some of our standards are even more stringent than these new regulations.

For example, the new GMPs require that manufacturers test the raw materials they purchase, at a minimum, for identification. In other words, companies must confirm that these materials are what the suppliers say they are. Some supplement manufacturers simply rely on the Certificate of Analysis documents provided by suppliers, which outline what materials they have provided, without testing them to confirm their identity or potency.

Here at Schiff® we have been testing our incoming raw materials since we began manufacturing supplements. We do this not only to ensure the identity of our raw materials, but also to:

• Test the potency of these materials.


• Ensure that they don’t contain any excess lead or arsenic, pesticide or herbicide residues, or objectionable organisms.


• Guarantee that they’ll be compatible with our manufacturing processes.

The new GMPs also establish a set of detailed manufacturing processes that must be documented on specific batch records. Furthermore, manufacturers are now required to outline any and all processes that could affect their finished products in their Standard Operating Procedures.

Schiff® has been participating in third-party GMP verification programs in conjunction with the United States Pharmacopeia (USP) and NSF International. The USP has been setting standards for drug manufacturing since 1820, and NSF International helped create NSF/ANSI Standard 173, the first nationally recognized standard to cover GMPs specifically for dietary supplements. As a participant in both of these programs, Schiff® has undergone rigorous inspections of our manufacturing facility and operations, as well as independent testing to ensure that our products meet the potency and purity claims on our labels.

At Schiff®, product quality is our first priority, and we feel that Good Manufacturing Practices are an essential part of that. We encourage customers to ask questions about our products and include our toll-free phone number and web site on all our product labels. To speak to one of our friendly and knowledgeable Consumer Services representatives, call us at 1-800-526-6251. Or for more information continue to explore www.schiffvitamins.com.