Supplements Manufacturers must be held to strict FDA and Food and Drug Administration safety guidelines in order to be sold in the US. The US Food and Drug Administration (FDA) establish regulations and requirements for dietary supplements, including those that are sold over the counter or by prescription. Some dietary supplements are over-the-counter and others are prescribed. Both contain ingredients that may not be regulated by the FDA.
The FDA periodically reassures manufacturers about the manufacturing of their products. The FDA sends warning letters to manufacturers or send them samples to be analyzed. If the company does not comply with the FDA’s requirements, the FDA will close the facility. FDA will also fine a firm if they fail to inform the agency about the events that led to the drug’s failure.
FDA regulates dietary ingredients that are used in these products manufactured by companies outside the US. Supplements containing all natural herbs or botanicals are not subject to the FDA’s requirements as those containing artificial ingredients are. Companies can still produce the supplements containing botanicals and herbs that have been proven safe for human consumption. This does not mean that FDA cannot inspect dietary supplement facilities.
Supplements manufactured by the US manufacturers are required to comply with the CFSAN database. The CFSAN is a compilation of all dietary supplements on the market. Supplements are required to meet a standard of safety in manufacturing, packaging, and handling dietary supplements. The CFSAN database provides manufacturers with data on the nature of ingredients, quantity in tablets or capsules, and the drug information that accompanies the products. Supplements manufacturers need to confirm that the source of the dietary supplement is reliable and consistent.
Dietary supplements are classified as drugs if the manufacturer intends to sell them as medicines. A health claim must accompany any dietary ingredient. Some manufacturers combine a health claim with other dietary ingredients so that when they are sold together the claim makes more sense. For example, it is common for a sports nutrition manufacturer to include an anti-oxidant in its product along with an energy supplement.
A dietary supplement can be considered a drug if it has a recognized medical purpose. However, dietary supplements are not considered drugs when they are sold as over-the-counter or OTC products. This is because they are considered dietary supplements and not drugs. Because of this fact many consumers feel that products sold in stores are less safe than those sold online. The FDA has received reports of tainted products and individuals who have died due to contaminated dietary supplements but it is difficult to prove that a death was caused by an adulterated supplement.