What are Good Manufacturing Practices?
Good Manufacturing Practices are regulations implemented by the United States Food and Drug Administration to ensure that certain products, including dietary supplements, adhere to quality standards. The GMP system seeks to ensure that products are produced in a consistent manner that reduces the risk that a product is unsafe, ineffective, or impure. Manufacturers, retailers, producers, and packagers of dietary supplements are required to take proactive steps and follow the recommended GMP to eliminate or minimize errors, contamination, or mix-ups.
GMP is designed to protect the consumer from products that are dangerous or ineffective. The practices cover every aspect of the supplement’s production, from obtaining the raw materials to producing the supplement to maintaining the equipment used during production and testing procedures. Inspections by the FDA identify some problems, but the FDA relies on complaints from consumers to also identify defective drugs or dangerous dietary supplements.
Failing to meet GMP standards can result in several actions by the FDA. The FDA can issue a safety warning or request that the company recalls the product. In severe cases, the FDA may bring a court action to request an order requiring the company to correct GMP violations.
GMP Violations and Male Enhancement Supplements
Retailers who market male enhancement supplements and other dietary supplements under their store brand must be extremely cautious. Many stores contract with third parties to produce the dietary supplements sold under their store brand. If a male enhancement supplement was manufactured in violation of GMP, the result could be an adulterated product or a product that has been mislabeled for content.
The manufacturers, distributors, and other parties involved in producing a dietary supplement could be named as parties in a lawsuit by consumers who have suffered injuries after using male enhancement supplements because the supplement was marketed under the retailer’s store brand.
Therefore, a retailer who did not have any substantive role in the production of a dietary supplement still could be held liable for damages. Retailers should take careful steps to ensure products under their store brand have been produced in compliance with all GMP.