Anyone manufacturing a product has a dream of building a brand. Like many other regulated industries, long-term success in the dietary supplement industry is dependent on regulatory compliance.
A recent Consumer Reports article stated that anyone with a credit card and $191 can make a dietary supplement that looks just like any dietary supplement capsules you might see in a drugstore or supermarket. It is true that the regulatory barriers to entry into the dietary supplement market are lower than those in other FDA-regulated areas – for example, FDA does not require a pre-market approval for finished dietary supplements. However, “lower barriers” does not mean “no FDA enforcement,” and temporarily flying under FDA’s radar can cost a company a lot in the long run.
All foreign and domestic dietary supplement manufacturing facilities making product for the US market are subject to FDA inspection authority. An FDA inspection will reveal any violations of the FDCA Act. FDA inspections focus on dietary supplement Good Manufacturing Practices (GMPs) that cover all aspects: equipment, plant, personnel, ingredients’ purity, quality control, etc. Companies whose facilities have not established compliant GMPs will be subject to a range of administrative, civil and even criminal penalties. FDA can revoke a facility’s registration, issue a warning letter, request a recall, or involve the Department of Justice for civil or criminal proceedings.
FDA has even greater inspection authority over imported goods. FDA can hold and detain shipments at the border for long periods based on the mere appearance of a problem with the labels, ingredients, or the foreign facility’s GMPs compliance. FDA finding an alleged violation can be a disaster without proper representation because an FDA import detention can lead to significant supply chain delay or uncertainty, and an eventual Import Refusal can lead to potential placement on Import Alert – leading to an indefinite period of automatic detentions for future shipments. FDA generally inspects a new importer’s first few shipments. So it is imperative that importers get their first few shipments right. FDA can sample imported supplements and test them for illegal ingredients, filth, colors, or other substances. However, FDA tends to focus heavily on labeling violations, because they are the easiest to detect.
The size of the market means that FDA may miss a dietary supplement company for a while; however, FDA will eventually notice and check on all facilities. For assistance with dietary supplement compliance, contact us today!
