May 18, 2023 5 min read

Are Dietary Supplements FDA Approved?

Are Dietary Supplements FDA Approved?


If you are concerned about the safety and quality of your vitamins and dietary supplements, you’re not alone.

Dietary supplements have gained popularity in recent years, with people seeking more natural ways to support their health and well-being. However, concerns about the safety and efficacy of these products have also risen, as they are not regulated the same way as prescription or over-the-counter drugs. 

Many people wonder if dietary supplements are regulated at all, and if so, what do the regulations cover?  

In the United States, the government does regulate the  manufacturing  of dietary supplements, aiming to ensure consumer safety, but they do not certify or approve individual products.  This is where things can quickly get confusing. 

Let's dive into the details of how the US government regulates the manufacturing of dietary supplements and why third party testing is crucial to look for as a consumer.

Does the U.S. Government Regulate Supplement Manufacturing? 

Yes, but not to the extent of pharmaceuticals.  The regulatory body responsible for overseeing dietary supplements in the US is the Food and Drug Administration (FDA).

While dietary supplements are not subject to the same rigorous approval process as prescription drugs (because they are classified more as a food-product and not medicine), the FDA does enforce specific regulations to protect public health.

The Dietary Supplement Health and Education Act (DSHEA) of 1994 provides the legal framework that guides the regulation of dietary supplements.

Manufacturer Responsibilities 

Under DSHEA, dietary supplement manufacturers are responsible for ensuring the safety of their products before they enter the market. They must follow good manufacturing practices (GMPs) and maintain quality control standards. FDA and GMP Certifications are earned and held at the manufacturer level, and not at the product level.  Another way to say this is that the individual labs that make the dietary supplements are who earn and hold certification, and not the individual products that they manufacture.  

For example, at Abundant Earth Labs, our manufacturing facility currently holds three certifications: FDA Certified, GMP Certified, and UL Certified.  These certifications must be applied for and approved on a yearly basis and they can include unannounced audits - or inspections - of the facility for quality control and ingredient strength and integrity.  

Manufacturers are required to properly label their products with accurate information about the ingredients and dosage recommendations. However, unlike prescription drugs, pre-market approval from the FDA is not mandatory for dietary supplements.


Does the FDA Regulate Supplement Labeling and Claims?

Yes.  The FDA mandates that dietary supplements must carry a Supplement Facts panel, resembling the Nutrition Facts label on food products. This panel provides information about the ingredients, serving size, and daily value percentages. 

Moreover, supplement labels must not make misleading claims regarding their efficacy in preventing or treating diseases. Manufacturers are permitted to make certain structure-function claims, which describe how a supplement may affect the structure or function of the body without referencing specific diseases or cures.


Does the FDA Certify or Approve individual Supplement Products?

No. The labs that manufacture dietary supplements can earn and hold FDA and GMP certifications, but not individual products.  When asked if our  Whole Food Multivitamins are FDA Certified, we must give the correct answer, “No” because no dietary supplements can technically be FDA Certified.  However, our lab is FDA Certified, amongst other certifications.

This is why it’s important to know a lot about the practices, processes, and certifications of the manufacturer making your favorite supplements. 

Are you buying from the actual custom manufacturer? Or, are you buying from a brand that is reselling a pre-made formula manufactured by someone else and is removed from the quality control process? Transparency and compliance is key in either scenario and you want to know how and how often the manufacturer is testing their supplement products during and post-production.


How is Supplement Safety and Quality Monitored?

The answer to this important question may come as a surprise to many. 

The FDA focuses on  post-market  surveillance to monitor the safety and quality of dietary supplements. It relies on adverse event reports from consumers, healthcare professionals, and manufacturers to identify potential safety concerns. 

If a supplement is found to be unsafe or mislabeled, the FDA has the authority to take enforcement actions, including issuing warnings, product recalls, or even pursuing legal action against the manufacturer.

The important fact is that the FDA monitors  post-consumption adverse effects of dietary supplements.  This means some quality issues only arise after the supplement has been consumed and issues are reported.  Yikes, right?

This is why, at Abundant Earth Labs, we believe third party testing is crucial.


Third Party Testing: What is It and Why is it Necessary

At Abundant Earth Labs, we have a strict set of processes in place to make sure every product you buy has the right strength, composition, purity, and quality of ingredients. We go above and beyond just being FDA and GMP certified and compliant.  Safety, excellence, and effectiveness are our top priorities.

This is why we participate in third party testing.  Third-party testing is when a manufacturing company sends its product to an outside, unbiased lab for testing to see if it meets the standards of the company, and to ensure that what is on the label is actually inside the product.

The best way to prevent adverse effects in supplements is to conduct strict, third party testing for microbial contaminants, molds, bacteria, heavy metals, etc before  a product reaches the market and can make someone ill. That’s our stance. 

Our organic vitamins are tested 3 times for purity and contaminants. First, our raw ingredients are tested separately, one by one, as they arrive at our lab.  Second, once our formula has been made and our tablets pressed, a sample is tested again for quality (that no contaminants entered during the manufacturing process) and quantity (that the amount of each ingredient we claim is accurate).  Finally, we send a sample from each batch to an independent, outside, 3rd party testing lab.

At Abundant Earth Labs we chose Daane Labs in Naples, FL as our 3rd party testing facility after researching multiple options.  They are brilliant microbiologists, incredibly responsive and friendly, and operate a family owned company with an impeccable reputation. 

Daane Labs conducts our third and final round of product testing, and only after we receive the results of their report does a batch of our Whole Food Multivitamins go to market - fresh, bioavailable, and safe.



While the US government regulates the manufacturing and sales of dietary supplements through the FDA, it is important to note that the regulations for supplements differ from those for prescription drugs. 

To ensure safety, consumers should actively research products and pose tough questions to supplement brands.

With so many dietary supplements on the market today, we hope you find the above information useful when making educated buying decisions.  If testing protocols are not mentioned, we always encourage you to inquire with the manufacturer.

Consulting a trusted healthcare or naturopathic professional and exercising caution will further aid you in making well-informed decisions about your dietary supplement usage.