Whether you believe supplements are good for you or not, most publicity leads people to believe that supplements are not controlled by the Food and Drug Administration (FDA) and therefore have the potential to do more harm than good.
The FDA does control the manufacture, labeling, and distribution of supplements.
In 1994, Congress passed the Dietary Supplement Health Education Act (DSHEA). This act established standards for dietary ingredients from defining what is a dietary supplement and identification of ingredients to labeling. The act gave the FDA authority over dietary supplements to include developing Good Manufacturing Practices (GMP) under Title 21 Code of Federal Regulation. This act was opposed by doctors and the drug industry primarily because supplements were considered food.
Between 1994 and 2003, there was much discussion and pressure brought to bear on the FDA to create a set of GMP for the supplement industry and increase enforcement. This was reasonable because since enactment of DSHEA, the industry was self-policing, using guidance from the food and drug manufacturing GMP.
In 2003, the FDA finally drafted GMP for the manufacture, warehousing, and distribution of dietary supplements. Public hearings were held around the country with industry. I attended the one in Oakland, CA. In June, 2007, the final GMP was issued. Many industry concerns had been addressed so there was general acceptance of them and the steps required for compliance. Manufacturers and distributors had up to three years to be in full compliance, based on their number of employees.
Supplement manufacturers must prove, through testing, the identity, strength, composition, and purity of each active ingredient in each product. If the company lists an expiration date — not required as supplements don’t expire as do drugs, they just loose potency — they must prove 100% potency on the expiration date. This is in addition to testing for microbial contamination and compliance with California’s proposition 65. If the company sells internationally, requirements of the importing country must also be met. These requirements are often stricter than the FDA. For single ingredient products, this process is fairly simple. However, many products contain multiple ingredients. Each ingredient must be tested. Tests must be run by an accredited lab and can run from less than $50 to hundreds of dollars per test.
In 2007, it was rumored the FDA was going to hire 3,000 inspectors dedicated to enforcing the dietary supplement regulations. In addition, contracts were signed with some states to provide assistance through their Departments of Health. As of 2010, the FDA has conducted 115 inspections. Figures for 2011 are not available, but I have heard the total number is now over 700. Companies have been fined and shut down. Violations have ranged from simple sanitation violations to not listing or testing all ingredients and including unauthorized drugs.
The FDA is serious about ensuring the quality and safety of nutritional supplements. More and more companies are spending tens of thousands of dollars each year to be inspected by private companies to ensure compliance before the FDA shows up. A few are hedging their bets, which they will lose. Others are closing because they can’t afford to comply.
Most manufacturers of nutritional supplements are responsible. They are complying with the GMP. The FDA is maintaining control and oversight.
Photo Credit: Wikimedia Commons