Federal Dietary Supplement Regulation Drugs must be approved by the FDA before they can be sold or marketed. Supplements do not require this approval.
Supplement
companies are responsible for having proof that their products are safe, and the label claims are truthful and not misleading. The FDA regulates dietary supplements as food, not as drugs.However, many dietary supplements contain ingredients that have strong biological effects that may conflict with a medication you are taking or with a medical condition you may have. Sometimes, products containing hidden drugs are also falsely marketed as dietary supplements, putting consumers at even greater risk. For these reasons, it's important to consult with a healthcare professional before using any dietary supplement. Read these consumer updates for more information.
The marketing, manufacturing, labeling, and advertising of dietary supplements are regulated by standards enforced by the FDA and the Federal Trade Commission. Today, health authorities must wait for a supplement to cause injury or death before removing a dangerous supplement from the market. Steve Mister is president and CEO of the Council for Responsible Nutrition, the leading trade association for the dietary supplement and functional food industry. If dietary supplements were just a benign waste of money, they would represent nothing more than a burden on consumers' wallets.
The most serious problem faced by responsible supplement manufacturers and consumers is that criminals sell unapproved drugs that are illegally marketed as supplements, but that is not a consequence of the law, but of illegal activity. Physicians, including doctors and pharmacists, play an important role in ensuring that patients use quality supplements and are aware of the risks associated with some dietary supplements. On the contrary, the FDA has remained silent and the industry's main trade group, the Council for Responsible Nutrition, has stated that the results “reinforce the idea that dietary supplements are safe products because supplements do not harm many consumers. Many people take supplements because they think they're safer than medications (because they're “natural”) or that they work better.
Under the Dietary Supplements Health and Education Act (DSHEA), the 1994 law that established the current regulatory framework for dietary supplements, the FDA does not generally carry out a pre-market review of dietary supplements and manufacturers are not required to provide the agency with basic information about their products, including names or ingredients, before selling them. Each pack of dietary supplements must have a QR code that, when scanned, verifies the registration and provides information about the product and its contents. DSHEA must be repealed and the FDA must strive to properly control the huge dietary supplement industry.
