The nutritional supplement and food industries are continually evolving. In efforts to protect the consumer the nutritional supplement industry is highly regulated both internally by stakeholders and externally by the FDA.
Since 1938, the Federal Food, Drug, and Cosmetic Act (FD&C) has given authority to the FDA to oversee the safety of food, drugs, and cosmetics. In 1994, the Dietary Supplement Health and Education Act (DSHEA) defined dietary supplements as food and not drugs, thus allowing nutritional supplements to continue to be consumed as they have been for hundreds of years without having to undergo hundreds of millions of dollars’ worth of drug safety testing and long wait periods.
In 2011, former President Obama signed the Food Safety Modernization Act (FSMA) as an extension of DSHEA, which shifts the focus from responding after a food safety problem occurs, to prevention of foreseeable hazards before they occur. It relies heavily on HARPC, a successor to HACCP. HARPC requires all food companies in the US, as well as firms that export food to the US, to register with the FDA and to have a written FSMA-compliant Food Safety Plan in place.
Under FSMA, firms are required to verify the effectiveness of the Food Safety Programs of all of their raw material suppliers. FSMA requires firms to show proof that suppliers have written Prerequisite Programs and Preventive Controls, including a Food Defense component to address both bioterrorism and Economically Incentivized Adulteration. And, for the first time, food safety regulation is being extended to include pet food and animal feed, although these industries within the US have voluntarily elected to use HACCP plans to self-regulate to ensure consumer safety and retention.
As the industry evolves, so must we. At Genysis, quality is of up-most importance to us. We strive to always comply with regulations as well as implementing processes and improvements to stay ahead of the game.
Written by: VP of Quality, Daisy Herpin.