The US FDA has announced plans to increase oversight of the supplements industry, targeting unlisted ingredients as well as disingenuous or deceptive health claims. The Administration has outlined the 12 warning and 5 advisory letters that it sent out earlier this month to companies suspected of selling formulations with unapproved drugs, or making unsubstantiated, illegal claims for treating diseases such as Alzheimer’s. With possible policy changes coming to the forefront, the oversight may lead to the greatest regulatory modernization since the inception of the policy, the Dietary Supplement Health and Education Act, enacted in 1994. While the FDA is not required to approve such products before their commercialization, the Administration has tasked the FDA with purging unsafe supplements from the market.
Supplement companies are able to avoid premarket approval and testing methods that are required for drugs, as the industry is regulated as food. Since the law was established in 1994, the industry has skyrocketed over 1,000%, growing from 4,000 products and $4 billion in annual sales to 80,000 products and $50 billion in annual sales.
Seventy-five percent of Americans regularly take dietary supplements, including 80% of the elderly population and 33% of children. In a 2015 study featured in the New England Journal of Medicine, approximately 23,000 emergency hospital visits in the US were due to consuming dietary supplements, with numerous visits related to cardiovascular issues tied to the use of weight loss or energy supplements.
Source: The Washington Post