An Overview of the FDA Dietary Supplements Regulations

Although there is no FDA dietary supplements approval process, manufacturers must be honest about the contents of their supplements.

What Are Dietary Supplements?

Dietary supplements include pills, capsules, powders, drinks, and other products containing vitamins, minerals, and herbs. Some supplements have vitamins that are necessary for good health while others contain herbs which are associated with holistic benefits.

Certain dietary supplements have been proven to improve consumers’ health. For example, calcium and vitamin D supplements are important for bone health. Similarly, folic acid may decrease the risk of birth defects when taken by pregnant women. For those who aren’t looking for a specific benefit, multivitamins are available to provide all-around nutrition.

Although these supplements can be beneficial, there are also some risks involved. Supplements are not pharmaceuticals but may contain naturally active ingredients which can influence prescribed medications.

For example, vitamin K is known to reduce the efficacy of warfarin, a widely used blood thinner. Supplements with St. John’s wort may change the way the body processes medications, resulting in a faster breakdown.

Additionally, taking too much of a vitamin can be harmful as well. Taking multiple vitamins with the same ingredients or eating a vitamin-rich diet, in addition to taking supplements, can lead to serious consequences such as organ damage.

Do Dietary Supplements Need FDA Approval?

Despite the significant consequences supplements can have on a person’s health, these products do not have to do through an approval process from the U.S. Food and Drug Administration (FDA). Based on the Dietary Supplement Health and Education Act of 1994, it is not the FDA’s duty to approve these products. Instead, it falls on the company to make sure its products are safe and marketed with true claims.

What Are the FDA Dietary Supplements Regulations?

Rather than requiring a lengthy approval process typically associated with pharmaceuticals, supplements are instead regulated in terms of how they are marketed and manufactured.

There are a variety of requirements mandated per FDA dietary supplements regulations, specifically the Dietary Supplement Health and Education Act, including the following:

• The products must be labeled with the term “dietary supplement” or an equivalent term such as “herbal supplement” or “calcium supplement”
• Supplements can not be marketed or sold as a treatment or cure for a specific disease or symptom
• Products cannot be adulterated or misbranded
• Manufacturers must report any serious adverse effects associated with their supplements
• Supplement producers must register with the FDA according to the Bioterrorism Act before selling dietary supplements
• Manufacturers must inform the FDA if they intend to market a supplement with a “new dietary ingredient” and show why the ingredient is expected to be safe

Supplement manufacturers are also required to follow manufacturing practices established by the FDA. These standards help ensure the composition, strength, purity, and identity of supplements in order to protect consumers and reduce contamination.

Regulations also require that vital information be included on supplement ingredient lists. Supplement Facts panels are required to identify each dietary ingredient included in the product and the amount contained. Any additional ingredients such as sources of dietary ingredients, food ingredients, additives, and processing aids are to be included in an “other ingredient” statement below the Supplements Facts panel.

How Are the Regulations Enforced?

In order to ensure that manufacturers are following manufacturing practices, the FDA may periodically inspect manufacturing facilities.

As its resources permit, the FDA can also review supplements’ marketing and labeling. If manufacturers are found to have violated FDA dietary supplements labeling regulations, the agency may take action, which in some cases may only include sending warnings to companies ordering them to change their labeling.

The FDA can take action any time it suspects a supplement is dangerous. Sometimes the agency releases public alerts to inform consumers of the issues. In more serious cases, the FDA may remove the products from the market and conduct criminal prosecutions.

A variety of issues may lead to an FDA dietary supplements recall, including any of the following:

• Contamination with microbiological, pesticide, or heavy metal content
• Absence of a dietary ingredient which has been listed as part of the product
• Too much or too little of a dietary ingredient based on the amount listed on the product label
• Bogus products that should not be on the market at all

For example, in 2011, the FDA released a mass warning after finding that nearly 300 dietary supplements had been fraudulently marketed. In some instances, the supplements reportedly contained active ingredients. Consumers reportedly suffered serious injuries from mislabeled dietary supplements, including life-threatening strokes, liver injury, kidney failure, heart palpitations, and death.

“These products are masquerading as dietary supplements—they may look like dietary supplements but they are not legal dietary supplements,” Michael Levy, who then served as the director of FDA’s Division of New Drugs and Labeling Compliance, said at the time. “Some of these products contain hidden prescription ingredients at levels much higher than those found in an approved drug product and are dangerous.”

Concerns about falsely advertised supplements have become especially relevant during the coronavirus pandemic. There is no vaccine for the potentially deadly respiratory virus, leaving many consumers scared and uncertain. Unfortunately, some businesses may be taking advantage of consumer fears by marketing supplements as able to treat or prevent COVID-19 infections.

At least two lawsuits have been filed regarding false claims that a supplement could cure COVID-19. TV pastor Jim Bakker has been sued by the states of Arkansas and Missouri for allegedly claiming that dietary supplement colloidal silver is a cure for the coronavirus. According to Arkansas’ lawsuit, nearly 400 people purchased more than $60,000 worth of the supplement from the televangelist’s company after he made claims that the product could cure the coronavirus.

A Michigan doctor has also been accused of promoting false supplement cures for the virus. According to a witness, the doctor promoted high doses of vitamin C as a cure. Although vitamin C is necessary, it is not known to have an effect on COVID-19.

Beauty influencers, actresses, and homeopaths have also made claims that supplements cure or prevent the coronavirus, and many Americans may be susceptible to believing these declarations. NBC News reported that in 2012, U.S. consumers spent $30 billion on alternative medicine. 

These claims are so prevalent that the FDA has established a dedicated website detailing the actions it has taken against fake COVID-19 cure products. According to the agency, companies who fraudulently market products as able to prevent, treat, diagnose, or cure the coronavirus are hit with warning letters, seizures, and even court-ordered injunctions in order to halt the sale of these things.

While the FDA often enforced FDA dietary supplements regulations by sending warning letters, at least one company — California-based Whole Leafs Organic, which sells CBD and other products — may be facing a lawsuit from the agency. According to the complaints filed against the company by the FDA, Whole Leafs Organic claimed that one of its nutritional supplements mostly made up of vitamin C could treat the coronavirus or reduce the risk of contracting it. Other products sold by the company were touted as being able to target and eliminate cancer cells, effectively curing cancer.

The FDA notes that it is working with researchers to develop vaccines and treatments for COVID-19. Some interventions have reportedly moved to the clinical trial phase, although the agency says that these unapproved products are still in the early stages and have not been evaluated for safety or effectiveness.

While researchers and medical experts work to manage the coronavirus outbreak in the country, the FDA recommends that consumers use caution when looking into products marketed for COVID-19 treatment. The agency states that unproven and untested “cures” can result in serious consequences, including death. Although consumers may only seek to protect themselves and their families, these fake treatments may do more harm than good.

“If it seems too good to be true, it probably is,” the FDA notes.

The FDA encourages consumers to be suspicious of fraudulent products and report any fake treatments to the agency so it can take action.

How to File an FDA Report

Although the FDA has the power to take action against fraudulent or dangerous dietary supplements, the agency doesn’t have the ability to test or monitor every single supplement available. In addition to encouraging the public to be wary when purchasing supplements, the FDA also asks consumers to report fraudulent products or adverse effects.

In addition to inspections, adverse events, and select laboratory analyses, consumer reports provide the FDA with significant information about potentially fraudulent supplements.

If consumers have been sold mislabeled or deceptive dietary supplements, there are a few options. They can contact their district’s FDA consumer complaint coordinator via telephone to inform them about an issue. Or they can also report problems to MedWatch, the FDA’s safety information and adverse event reporting program.

Consumers may also take legal action if they were harmed by dangerous or mislabeled supplements. An experienced attorney can evaluate the case and see if they are eligible to recover compensation for potential consumer protection law violations.

Join a Free California Supplements Class Action Lawsuit Investigation

If you live in California and purchased a dietary supplement with a label that touted health claims you believe may be false and misleading within the last four years, you may have a legal claim.

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This article is not legal advice. It is presented
for informational purposes only.