A Deep Dive Into Supplement Safety: How Nutrafol Goes Above and Beyond

There is a lot of misunderstanding about if (and how) supplements are regulated. The quick answer is, they are: The FDA, or Food and Drug Administration, regulates and oversees dietary supplements by monitoring ingredient safety, adverse events reported by consumers and industry, product labeling and claims, and enforcing current Good Manufacturing Practices in supplement facilities.¹ 

At Nutrafol, we don’t make compromises when it comes to quality and safety—because we care as much about what goes into your body as you do. We continue to push the standards for dietary supplement research, advancing the science of hair and skin health to deliver meaningful results. 

Nutrafol Hair Growth Nutraceuticals are NSF Contents Certified, a third-party certification that signifies a product meets quality and safety standards set by the FDA to help consumers make safer decisions when choosing supplements.

Read on to learn more about supplement regulation in the United States and how Nutrafol goes above and beyond what’s required to prioritize our customers’ safety and our products’ efficacy.

While the FDA does not approve dietary supplements before they go to market, it regulates supplements already on the market through a variety of surveillance protocols. Thanks to the Dietary Supplement Health and Education Act (DSHEA), the FDA has authority to regulate:

This means the FDA is responsible for ensuring companies are safely producing products with proper supplement labels and safe ingredients.^1,2

Manufacturers must ensure their products are not only safe and lawful, but also that their label claims are truthful and have evidence to support them. The FDA then has the authority to inspect manufacturing facilities for product quality and labeling, including ensuring product claims such as the Supplement Facts Panel meets FDA requirements.¹

It all starts with facility registration. All facilities involved in the production of dietary supplements marketed in the United States must first register with the FDA—even if they technically exist outside the U.S. This includes facilities that might not be directly manufacturing the products, but still have any role in processing, packing, or holding them. The FDA then enforces Good Manufacturing Practices (GMP), which are a set of mandatory requirements that ensure products are made safely and meet their quality standards, through onsite inspections and audits.¹

Importantly, the FDA also regulates the safety of individual ingredients. Ingredients in dietary supplements must be safe for their intended use (in other words, how much and how often the ingredient would be taken if someone followed the supplement directions). Ingredients can be recognized as safe by qualifying for different ingredient classifications.¹ 

For example, some ingredients have a long history of being used safely for their intended use, which earned them the classification of Generally Recognized As Safe, or GRAS. Another way that an ingredient could be recognized as GRAS is through a pre-market notification sent by the ingredient supplier or manufacturer to the FDA, which outlines qualified expert consensus that the substance is safe under the conditions of its intended use. Many different vitamins and minerals are classified as GRAS.^3,4 

Ingredients may also fall under the New Dietary Ingredient Notifications classification, or NDIN. In this case, ingredient manufacturers are responsible for notifying the FDA about using novel ingredients, including details on how they concluded this ingredient will be safe for its suggested use. The FDA then reviews these details and can object if the notification raises safety concerns or is missing necessary information.^1,5 

FDA regulations require manufacturers to follow specific labeling requirements so consumers have transparency on what a supplement is, who markets it, and accurate ingredient and nutritional information. This means the FDA requires companies to disclose everything significantly present in their dietary supplements and how much is in each serving. These regulations demand transparency—anything not listed on the Supplement Facts Panel must be listed underneath as “other ingredients.”¹ As an example, the top 9 US food allergens must be disclosed on the label if present in the formulation.

The FDA also requires companies to report any serious adverse events involving their products, such as hospitalization, within 15 business days. The FDA monitors these adverse event reports, as well as other product complaints from healthcare providers and consumers, to help identify any products that might be unsafe. If they find a product is potentially unsafe or not in compliance, they can work with the manufacturer to get the product into compliance, or, if needed, remove it from the market.^1,6

Nutrafol Hair Growth Nutraceuticals, Clear Skin Nutraceutical, and Hair Wellness Duos are manufactured in the USA using domestic and imported ingredients in GMP-certified facilities, which means they meet the high-quality standards the FDA expects of facilities involved in USA supplement production. Nutrafol’s dedicated Quality and Regulatory teams ensure we comply with federal, state, and local regulations, including adherence to FDA GMP requirements that set standards for quality and safety. Our suppliers are regularly audited to ensure compliance with certifications, FDA registration, and GMPs.

We source high-quality ingredients and verify them by ensuring they are tested for proper identification, potency, and purity. During the formulation process, we collect documentation that helps evaluate and determine whether an ingredient meets our strict requirements, including confirming its nutritional content, quality, and safety.

Once the ingredients are combined to make our formulas, testing of the final product for Supplement Facts Panel label claims, microbiological safety, and CA Prop 65 heavy metals occurs on every batch and is reviewed by Nutrafol’s Quality Assurance team to ensure it meets all established specifications. Testing is performed at our manufacturers' in-house laboratory and a third-party ISO/IEC 17025:2017 certified laboratory. This certification is the international standard for testing and calibration, ensuring the accuracy and reliability of testing results.⁷ This means our formulas contain the ingredients as described on the label.

On top of all that, each of our formulas undergoes a safety assessment by expert toxicologists for the formula's intended use and on the intended population. This includes a review of ingredient upper tolerance, history of safe use, and the combined use of different recommended products. This means that if the combination of a Nutrafol Hair Growth Nutraceutical and Hair Wellness Duo product is available on our website, our expert toxicologists have approved the use of these products together.

All Nutrafol supplements have gone through a safety assessment that evaluates ingredient safety for the intended use of 6 months and beyond. Although our clinical studies look at specific periods of time (for example, 6-12 months), you might be surprised to know our safety assessment is actually based on lifetime use of the product. This means that when used as directed, expert toxicologists have found no red flags with long-term use in intended healthy populations based on the current safety data. As always, please refer to each product's directions and cautions, and if you have concerns, a medical condition, or are taking prescription medications and/or other supplements, we advise you to speak with a trusted healthcare provider before adding Nutrafol supplements to your routine.

At Nutrafol, we’re committed to bringing our customers safe products that are effective. Every ingredient and formulation undergoes extensive research by our team of internal biologists, chemists, and clinical experts to ensure we continue to set the standard and deliver meaningful results. 

Nutrafol supplements are physician-formulated, and all ingredients and their amounts were selected based on published data by the National Institutes of Health (NIH), National Academies, or other evidence-backed research showing efficacy and safety. This means our formula amounts are based on what established, accepted research from the scientific community indicates to be both safe and effective. However, we understand that ensuring safety is an ongoing process. That’s why our in-house clinical and science innovation teams monitor for any changes in safety—meaning we continue to stay on top of updated research. 

While each ingredient is already selected based on substantial evidence to meet the desired purpose of each product, we don’t stop there. Final formulations of Hair Growth Nutraceutical and Clear Skin Nutraceutical products also go through clinical testing to actually test their efficacy. In other words, we don’t just want to tell you they should work based on piecing together existing research; we test the full formulations for ourselves.

Additionally, Nutrafol Hair Growth Nutraceuticals are NSF Contents Certified, one of the most rigorous testing processes for dietary supplements to ensure product quality and safety. It protects consumers by testing products for harmful levels of contaminants and certifying that they contain the ingredients listed on the label. NSF testing includes:

Although the FDA has regulatory oversight for dietary supplements and is responsible for claims, labeling, and manufacturing, requiring that product claims are truthful, not misleading, and substantiated to protect consumers from harm, it does not expressly require a certain level of scientific proof to support the efficacy of dietary supplements.

Though not required, we prioritize investing in high-level clinical studies, which we share with the scientific community through peer-reviewed publications (meaning they undergo careful scrutiny by experts in the field before being published) and then present our findings at prominent dermatological and medical conferences. All of our clinical studies are conducted by independent clinical research centers, approved by an institutional review board, and are in compliance with Good Clinical Practice​ (GCP) guidelines. 

Scientists outside of our company meticulously performed, monitored, examined, and verified the studies, substantiating what each product can do. That means you’re not just taking our word for it. We’re proud to report we have completed, published, and/or have ongoing studies on all of our Hair Growth Nutraceuticals and Clear Skin Nutraceutical. You can read more about Nutrafol clinical studies here.

At Nutrafol, we prioritize putting our hair health innovations to the test and are proud of the rigorous approach taken to our formulations, compliance, clinical studies, research, and scientific support. We carefully adhere to FDA laws and guidance to ensure that any claims regarding the benefits of Nutrafol products are consistent with regulatory and legal requirements. 

Our goal is to provide the information necessary for you to make an informed decision in choosing support for your hair health journey. To ensure you’re taking advantage of our diligent safety and regulatory standards, it’s best to only purchase Nutrafol products directly through Nutrafol.com or other Authorized Nutrafol Retailers such as Sephora, the Nutrafol Store on Amazon, or select healthcare providers.