For years, dietary supplement manufacturers and marketers have been under the microscope when it comes to meeting label claims. The media are quick to highlight lack quality, methods of analysis, and safety. The media are also quick to feature the rogue companies that attempt to cut corners and manufacture adulterated products that do not meet label claims.
In June of 2007, the Food and Drug Administration (FDA) released its final rule on current Good Manufacturing Practices (cGMPs) for dietary supplements. For the first time, supplements would be distinguished from other food products and subject to their own distinct set of GMP requirements if sold or offered for sale in the United States.
The FDA’s objective in drafting the final rule was to establish quality, process, and recordkeeping controls to help assure that supplements manufactured or sold in the U.S. met specifications for identity, purity, strength, and composition and are manufactured under conditions to prevent adulteration. The FDA was largely successful in providing a flexible framework for manufacturers of all sizes to implement their own finished product testing procedures and vital in-process testing. Furthermore, cGMPs place additional responsibilities on manufacturers to ensure that their suppliers provide a wide range of documentation proving the ingredients are what their supplier says they are.
I love that cGMP requirements were established to be flexible for each manufacturer. Companies have the latitude to decide internally how to best implement the necessary controls by using scientifically sound design, processing methods, and testing procedures. The flexibility in these regulations allows companies to use modern technologies and innovative approaches to achieve higher quality through continual improvement. This is a key point. Many tend to overlook the "c" in cGMP, which stands for "current." This is very important in that it requires manufacturers to use technologies and systems that are up-to-date in order to comply with the regulations that are in place. Systems and equipment that may have been the very best 10 years ago may be less than adequate by today's standards.
If the failure to meet cGMPs results in the distribution of a defective product, the company may subsequently recall that product. This protects the public by removing these products from the market. While the FDA cannot force a company to recall a product, companies will usually recall voluntarily or at the FDA’s request. If a company refuses to recall a product, the FDA can warn the public and could seize the product that is on the market, which could do irreversible damage to the brand. Refusal to recall a product is business suicide.
Moreover, even if the product was proven to not be defective, the FDA can bring a seizure or injunction case in court to address cGMP violations. When the FDA takes this action, the agency will ask the court for an order that allows federal officials to take possession of “adulterated” products and destroy them. And this ultimately accomplishes the FDA’s objective of preventing a manufacturer from distributing those products to consumers. Ultimately, a manufacturer needs to think long and hard about fighting this type of battle with the FDA; it can be very costly and time consuming. When the FDA brings such a case, it asks the court to order a company to stop violating cGMPs. Both seizure and injunction cases often lead to court orders that require companies to take many steps to correct cGMP violations, including hiring outside experts, creating a plethora of new documents, and re- training employees. If the situation were bad enough, the FDA could also bring a criminal case.
GMP requirements apply to each and every domestic and foreign company that manufactures and packages dietary supplements for sale in the United States. And this includes all those involved in manufacturing, distributing, testing, quality control, and labeling of dietary supplements.
GMP certification is very expensive to implement and maintain. In fact, when cGMP was implemented in 2007, many companies were forced to hire cGMP-certified contract manufacturers or just plain forced out of business. Nonetheless, cGMP certification provides companies with a competitive advantage and protects consumers, which is the top priority. Before GMP was implemented, the industry was under an honor system of sorts. And most of these companies made every effort to provide quality, science-based products to consumers. However, bringing a product to market is far too complex without having a viable system in place. For now, GMP is that system.