The American dietary supplement industry reached a valuation of 151.9 billion dollars in 2021. This figure dwarfs the budgets of many small nations and represents a massive economic engine. The market contains over 95,000 distinct products.
The Dietary Supplement Health and Education Act of 1994 classifies supplements as food rather than drugs. This law means manufacturers do not need to prove their products were safe or effective before selling them to the public. The burden of proof shifts to the Food and Drug Administration to remove a product only after it has caused harm.
Only about 20 percent of herbal supplements tested by the New York Attorney General in 2015 actually contained the plants claimed on their labels. Investigations also found that 92 percent of tested herbal supplements contained lead and 80 percent contained other chemical contaminants. A study of supplements sold between 2007 and 2016 identified 776 products containing unlisted pharmaceutical drugs.
Liver injury accounts for 16 to 20 percent of all supplement-related injuries in the 21st century. The most common culprits include green tea catechins, anabolic steroids, and the herbal extract aegeline. These substances can cause hepatocellular damage resulting in jaundice and other serious health complications.
The European Union Food Supplements Directive of 2002 requires that supplements be demonstrated to be safe in both dosages and purity before they can be sold without a prescription. The European Court of Justice upheld these measures to protect public health despite petitions from over one million consumers and various doctors and scientists in the United Kingdom. This directive establishes clear procedures for adding substances to permitted lists based on scientific evidence.