How does the FDA regulate dietary supplements?
The Food and Drug Administration (FDA) has regulated dietary supplements since at least 1938. At the time they were regulated like any other food, however. In the 1980’s they became defined as “food additives,” leading to a lot of confusion and inconsistent regulatory standards. The Dietary Supplement Health and Education Act (DSHEA) of 1994 set the foundation for the way dietary supplements are categorized, sold and regulated today.
While there are some critics of the FDA’s regulation of dietary supplements, they do their best to keep the public safe. Important changes have been implemented since the 2011 Food Safety Modernization Act (FSMA). The scope and form of regulation can be divided into three areas: formulation, manufacturing processes, and consumer safety. Each area works in concert to create products that are researched, reliably potent, and safe.
Formulation of Dietary Supplements
The definition of a dietary supplement, as established in the 1994 law, encompasses “vitamins, minerals, herbals and other botanicals, as well as amino acids and other dietary substances used to supplement the diet, and any concentrate, metabolite, constituent or extract of those items.” It is the manufacturer’s responsibility to be able to conduct testing for every ingredient they use. That testing is used to prove that their product is exactly what they say it is and as potent as they claim. Those tests may be for final product or as an ingredient sold to another manufacturer.
In instances of business to business sales, it is also the obligation of the buyer to validate the claims of the seller. When an audit or product incident occurs, the FDA will validate not only the results of the tests but that the tests are appropriate and accurate.
If a product is being sold to a consumer the manufacturer must be able to prove that every batch of the product meets the claims made on the product label. Whatever company has their name on the label is responsible for the claims made on the label; whether it is the manufacturer or an Own Label Distributor (OLD). This is done by keeping records of their ingredient lab results and what batches those ingredients went into.
The FDA further regulates dietary supplements by monitoring a company’s manufacturing process though prescribed Good Manufacturing Practices (GMP’s). Current GMP’s (cGMP) say that any product “has been prepared, packed or held under conditions that do not meet current good manufacturing practice regulations” to be compromised and thereby unfit for sale. The FDA can respond with warning letters and possible prosecution. Consumers are increasingly aware of what they are putting in their bodies.
Third party certification programs like the Safe Quality Food (SQF) Institute are becoming a standard bearer recognizable by consumers. Their certifications typically go above and beyond what is required by the FDA but also gives companies a competitive advantage. Buyers and retailers may also require certain certifications to be shelved in their stores.
Since the enactment of DSHEA in 1994 the FDA has been able to request voluntary recalls from manufacturers if it determined that there was “a serious or unreasonable risk of injury or illness.” Since 2006 with the Nonprescription Drug and Dietary Supplement Consumer Protection Act manufacturers are now required to alert the FDA of “serious adverse events” in reported to them in association with their products. Manufacturers are also required to maintain a record for six years of any and all complaints and events reported to the company.
The Food Safety Modernization Act (FSMA) put the sharpest arrow in the quiver of the FDA in terms of authority. On top of their audits of GMP’s the FDA may issue a mandatory recall if it determines that a product may cause serious adverse health effects.
Today’s FDA has a powerful arsenal to ensure the products dietary supplement manufacturers produce are safe and effective. Between them and the third party certificates available consumers can be assured that the products they purchase will be as advertised and safe to consume.