Examples of FDA Bias and Information Quality Act Violations

The FDA has waged a regulatory war on dietary supplements and botanical products for decades. In 1994, the FDA lobbied the Congress to ban dietary supplements and vitamins claiming huge numbers of adverse medical events and dozens of deaths from the use of dietary supplements and vitamins. The FDA solution: Ban all dietary supplements and botanicals and force each of those products to be subject to the new drug application process (a process that takes an average of 10 years and costs as much as $5 billion). In response, the U.S. Congress rejected the FDA’s claims against these products and unanimously voted to enact the Dietary Supplement Health & Education Act (DSHEA) in 1994 that severely limited the FDA’s regulatory control over dietary supplements, dietary ingredients, and vitamins. Research demonstrates the supportive role micronutrients like vitamins A, C, & D, and zinc can play in reducing the risk of acute infection and/or enhancing the body’s response to vaccinations, and, when supplemented in an individual’s diet, potentially shortening the duration and severity of disease.i Recent surveys show that as consumers continue to confront the devastating public health effects of COVID19, Americans are focused more than ever on their overall health and well-being. As evidenced in the survey, dietary supplements continue to play a critical role in the lives of most Americans, and even more so in light of the ongoing health crisis. More than three quarters of Americans report taking dietary supplements

KEY FINDINGS

  • Congress had to reign in the FDA in 1994 when the Agency claimed dietary supplements and vitamins were causing adverse medical events and deaths. The DSHEA Act imposed significant restraints on the FDA’s regulatory authority on those products.

  • Dietary supplements and vitamins play an important role, particularly during the pandemic, in helping consumers maintain their health and well-being.

  • FDA has waged a regulatory war against kratom filled with inaccurate, distorted, and false information since 2012, and that has led to 6 states banning kratom.

  • Big Pharma has little interest in developing a kratom drug unless the FDA can ban consumer access to the natural plant.

  • The FDA’s propaganda campaign against kratom has misled state and local government jurisdictions in an effort to enact local bans. Regulation is needed to protect consumers from adulterated kratom products, not a ban.