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Understanding FDA Regulations and What They Mean for Menopause Dietary Supplements

Corey Whelan

Menopause may be a natural part of life, but it’s not without uncomfortable symptoms. Dietary supplements designed to address certain menopause symptoms can often help, but many may wonder if the supplements they’re taking are FDA vetted or approved, and what the regulatory process is like for bringing them to market.

It’s important that you trust and feel good about the supplements you choose to take. In order to do that, it may help to understand how the U.S. Food & Drug Administration (FDA) regulates dietary supplements, and what you, as a consumer, can do to choose wisely.

Does the FDA Approve Dietary Supplements?  

The FDA refers to itself as a consumer watchdog group.1 Its mission is to protect public health by ensuring that the drugs, biological products, and medical devices sold and used within the U.S. are safe.2

In 1994, the FDA’s authority to approve and regulate dietary supplements was made clear, when the Federal Food, Drug, and Cosmetic Act (FD&C Act) was amended by the Dietary Supplement Health and Education Act (DSHEA).3 The Act defined what a dietary supplement is and clarified the FDA’s role in approving and policing these types of products.

Under current law, the FDA does not have the authority to approve dietary supplements or their labeling before they come to market. That may sound scary, but it doesn’t mean that the supplements you take aren’t safe or regulated.

It's important to understand that there is a distinction made by the FDA between drugs and dietary supplements.

Drugs are defined as substances used to treat, diagnose, cure, or prevent disease.4 Drugs go through clinical trials, as well as an independent review process, before they’re made available to the public.5

Dietary supplements, on the other hand, are not intended to cure, prevent, or treat disease. The manufacturers and distributors of these products aren’t legally able to make those claims; and if they do, it’s a big red flag for consumers.

Since their intended use differs, dietary supplements aren’t required to go through the same approval process as drugs. “Menopause is a natural process, and not considered to be a disease state or a disorder. Our products are not drugs, nor do we make drug claims,” explains Salma Fathalla, Senior Director, Quality and Regulatory at Bonafide.

She explains that it’s the manufacturer’s role to make sure dietary supplements contain exactly what’s on their label before they’re distributed. “It’s the primary responsibility of manufacturers to guarantee the public that the dietary supplements they sell are safe, and not misbranded, or adulterated,” she continues.

Does the FDA Regulate Dietary Supplements? 

After they hit the market, dietary supplements are regulated by the FDA as food, not as drugs.6

“Since the FDA doesn’t approve dietary supplements in the same the way it approves medications, the current narrative, unfortunately, is that they’re not involved in the policing of these products. However, that’s not the case,” says Ms. Fathalla.

By law, the FDA has the legal authority to periodically inspect manufacturing facilities to ensure that manufacturing requirements are being met.7 

It may also choose to review product labels, marketing materials, and website content to ensure that inaccurate claims about a dietary supplement's ability to treat, cure, or prevent disease, are not being made.8   

In addition, the FDA is tasked with monitoring any adverse reactions and complaints that are reported by healthcare providers and consumers regarding dietary supplements. If necessary, the FDA can have an unsafe supplement removed from the marketplace.9

Understanding GRAS and NDI   

In addition to regulating dietary supplements, the FDA also regulates dietary ingredients used in both food products and supplements.10

‘Generally recognized as safe’ ingredients, commonly referred to as GRAS, are substances that have undergone safety evaluations by scientific experts who aren’t affiliated with the government. GRAS ingredients have been determined to be safe, when used as directed and intended.11

GRAS ingredients may also refer to substances that had been used extensively by a large population of people prior to 1958, without harm.12 GRAS ingredients do not require FDA approval,13  and you can see a complete list of GRAS ingredients on the U.S. Dept. of Health and Human Services GRAS Substances list.

Science is ever-changing, and new ingredients and substances are discovered or used in new ways all the time. If a manufacturer wishes to introduce a new dietary ingredient to the market they can do so, although the process is rigorous.

The New Dietary Ingredient (NDI) Notification Process requires that the FDA is informed about the use of new dietary ingredients in supplements by the manufacturer or distributor. This notification must include information about the new ingredient’s safety, and the process by which the manufacturer determined its safety.14

If you’re using, or are considering using a Bonafide product, you’ll be happy to know that we go above and beyond what’s required. “We abide by all FDA regulations. We go through certifications and follow the rules to the letter, including those for NDI applications, so no one can say down the line [and so we may reassure customers] that we’re not using good ingredients. The meetings can be grueling! But we do it to ensure that we produce only safe and effective products,” says Ms. Fathalla

Tips for Choosing Safe Dietary Supplements

Unfortunately, not every dietary supplement manufacturer adheres to FDA regulations. The FDA also may not “catch” every problematic marketing campaign, or mislabeled supplement. For that reason, it's important for you to protect yourself by staying informed about the supplements you choose:

  • Look for transparent manufacturers – check out the company’s Better Business Bureau profile and reviews on watchdog websites, like TrustPilot, to assess if a consistent or large body of complaints exists against them
  • Read online reviews – look for reviews on multiple websites, if they’re available, to assess if the supplement is worthwhile
  • Read labels – you can compare ingredients and dosages between brands by reading labels on the National Institutes of Health (NIH) Dietary Supplement Label Database
  • If it sounds too good to be true, run – no dietary supplement can cure a disease, reverse aging, or make you look or feel 25 years younger. When supplement claims sound too good to be true, they’re probably false
  • Talk to your healthcare provider – supplements may not be drugs, but they can interact with the drugs you’re taking. Before adding a dietary supplement to your regimen, talk to your healthcare provider or pharmacist to determine if it is a safe fit for you



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* These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

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