FDA FAQ: The FDA’s Role in the Supplement Industry

As a curious and informed health enthusiast, you might have noticed a statement on supplements and websites like ours that sparks some questions or even concerns.

“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.”

It might make you wonder what this really means. Does the FDA regulate supplements? Does the FDA regulate vitamins? Are my supplements safe to take? To answer these questions, let’s first take a step back to understand the role of the FDA and what it means for you and your health.

What Is The FDA?

The FDA, or Food and Drug Administration is a federal agency responsible for regulating products that impact public health. Their aim is to help ensure the safety of all sorts of goods that are part of our daily lives, from food and drugs to cosmetics and even pet products. But the role and level of oversight the FDA has on consumer products varies quite a bit, and it’s important to understand how this impacts the products you purchase and consume.

The Difference Between Drugs & Supplements

While it may seem like supplements should be evaluated similarly to medications, the FDA categorizes drugs and supplements separately. Drugs are a standalone category with their own regulations and requirements.

According to the FDA, drugs are for treating, preventing, mitigating, diagnosing, or curing diseases. Because the FDA defines drugs this way, they evaluate drugs not only for safety but for efficacy of the treatment to the condition they are intended to manage. To make the type of claims that drugs can make, the FDA requires clinical trials on human subjects to prove that a drug is both safe and effective. Drugs also face strict requirements on how they are manufactured and packaged.

Supplements, including vitamins, are considered a subset of food products. The FDA states that supplements, like food, are for nutritional purposes only. As we know, appropriate nutrition obtained through both food and supplements can support your body in both maintaining health and fighting illness.

It’s important to understand the distinction between these definitions and the subsequent health claims that can be made about each one. By definition, a drug is used to treat a health problem, while vitamins and supplements are used to support good health.

Are Supplements Regulated By The FDA?

While supplements are not subject to the same regulations and monitoring as drugs, the FDA does have regulations for manufacturing and labeling supplements, called Good Manufacturing Practices (GMPs). They conduct regular thorough inspections of supplement companies to verify that the GMPs are being practiced in full compliance and issue corrective action letters where necessary. However, they do not provide companies or products with any type of certification to authorize compliance.

The GMPs are different than the guidelines for testing, safety, and efficacy in place for pharmaceutical drugs. Unlike drugs, supplements do not require research to back their efficacy, nor do they require pre-approval by the FDA before they are released for sale to the consumer.

That’s not to say that the ingredients in supplements are never tested or studied, just that they aren’t required to be, and the FDA isn’t necessarily validating any of it.

Supplements are intended as a supplement to your diet, and they are regulated as such. Just like strawberries, which are packed with vitamin C, don’t come with a proven claim that they boost immunity, neither do supplements.

What This Means For You

It can be easy to get lured by lofty claims and trendy supplements, but the reality is, the claims you see may not be all they’re made out to be. Be vigilant and do your own research on ingredients and companies. Don’t be shy to reach out to manufacturers directly to ask questions about ingredients, manufacturing processes, and testing.

At Pure Synergy®, we believe in full transparency in all that we do. We’re always happy to take your call or respond to your email, because we’re proud of our products, we stand behind our quality, and we care about your health.