Are Nootropics Legal? It’s one of the most frequent questions asked by consumers and, increasingly, by new dietary supplement brand owners exploring product development. In this article, we will define what nootropics are, examine how they are regulated in the United States, outline the key compliance challenges facing U.S. manufacturers, and provide guidance on how brands can navigate this complex regulatory landscape. To start, let’s establish a clear definition of what qualifies as a nootropic.
Nootropics are substances that are taken with the intent of improving cognitive functions such as memory, focus, and overall brain performance. Nootropics can be natural, synthetic, or pharmaceutical.
Within the dietary supplement industry, nootropics have experienced rapid growth and consumer interest. The global nootropics market is estimated at $5.71 billion in 2025 and is projected to reach nearly $19.53 billion by 2034, reflecting a strong compound annual growth rate (CAGR) of 14.64%.1Precedence Research Nootropics Market Size Projected to Attain USD 19.53 Billion by 2034. yahoo!finance. August 14, 2025. Retrieved September 8, 2025 from https://finance.yahoo.com/news/nootropics-market-size-projected-attain-150000143.html.
At the same time, it is essential to recognize that not all nootropic substances fall within the scope of dietary supplements. Because certain compounds (often referred to as “smart drugs”) are regulated as pharmaceuticals, supplement brand owners must be especially mindful of the regulatory boundaries that govern ingredient selection, marketing, and labeling. Understanding these distinctions is critical to developing compliant, market-ready nootropic supplement formulations.
How Nootropics Are Regulated in the U.S.
In the United States, most nootropics are categorized as dietary supplements. This includes natural ingredients such as herbs or amino acids like L-theanine, as well as certain synthetic or partially synthetic substances such as huperzine A (which can be produced via a chemical synthesis process or naturally from Chinese club moss [Huperzia serrata]).
However, pharmaceutical nootropics are medicines and would be illegal nootropics if sold as dietary supplements.
The Main Agencies That Oversee Nootropic Supplements in the USA
Within the U.S., nootropic supplements fall under the same regulatory framework as other dietary supplements. Two federal agencies share primary responsibility for oversight:
- Food and Drug Administration (FDA) – This agency is responsible for overseeing product safety and manufacturing, as well as ingredient oversight and product labeling. It is their job to ensure purity, quality, and consistency, and they can act against unsafe supplements. Although there are a few different laws associated with this role, the primary one is the Dietary Supplement Health and Education Act of 1994 (DSHEA). The FDA has the authority to take enforcement action against unsafe or misbranded supplements.
- Federal Trade Commission (FTC) – This agency is responsible for regulating supplement advertising across all media, including television, print, radio, internet, and social media. They are responsible for ensuring that claims are truthful, not misleading, and substantiated by competent and reliable scientific evidence.
Controlled Substances Act
The Controlled Substances Act (CSA) in the United States doesn’t classify nootropics as a single category. Rather, it regulates substances individually based on their chemical structure, abuse potential, and accepted medical use.
Most dietary ingredients (e.g., herbs, etc.) are not scheduled under the CSA and are sold as dietary supplements.
In contrast, certain synthetic or pharmaceutical substances marketed as cognitive enhancers are controlled under the CSA. This includes amphetamines (e.g., Adderall), methylphenidate (Ritalin, Concerta), Modafinil / Armodafinil, Piracetam and related racetams, and certain wakefulness agents (e.g., Adrafinil, Sunifiram, Noopept).
Nootropics that are Legal in the USA
A common question among supplement brand owners is: “Are there FDA-approved nootropics?” The answer is no. There is currently no mechanism by which dietary supplements can be “approved” by the FDA. Instead, supplements (as discussed earlier) are regulated under DSHEA, which sets requirements for safety, labeling, and permissible claims. As such, there is no official list of FDA-approved nootropics.
However, there are dozens of potential nutraceutical ingredients that are legal nootropics that can be sold in the U.S. as dietary supplements. Here is a partial list of natural nootropics commonly used in dietary supplements:
- Ginkgo biloba
- L-theanine + caffeine
- Creatine
- Lion’s mane mushroom extract
- Bacopa leaf extract
- Asian Ginseng root extract
The Biggest Challenges for U.S. Nootropic Makers
For companies developing and marketing nootropic supplements in the United States, several key challenges must be carefully navigated to remain compliant and competitive.
Lack of Regulatory Standardization
In the United States, dietary supplements are regulated under federal standards that generally apply consistently across all states. However, once you move into international markets, regulatory requirements vary significantly from one country to another. This lack of harmonization creates a major challenge for nootropic supplement companies seeking global reach.
Even if a particular nootropic herb is permitted in multiple markets, there may be differences in how it can be used. These differences may include:
- Acceptable forms of the ingredient (extract, whole herb, isolated compound, etc.)
- Permissible potency levels
- Types of claims allowed on product labels
- Label formatting and language requirements
- Rules regarding registration of the finished product with national regulatory agencies
Because each target country establishes its own regulatory framework, companies must carefully evaluate requirements on a market-by-market basis. For this reason, it is highly advisable to partner with a Contract Development and Manufacturing Organization (CDMO) that has extensive international regulatory experience and can help navigate these complexities.
Ensuring Safety, Efficacy, and Quality Control
Another significant challenge for nootropic supplement brands is ensuring the safety, efficacy, and quality of their products. Unfortunately, Nutraceuticals World2Montemarano M. Herbal and Botanical Supplements Continue to Outpace Broader Market Amid Economic Uncertainty. Nutraceuticals World. July 6, 2023. Retrieved August 1, 2024 from https://www.nutraceuticalsworld.com/issues/2023-07/view_features/herbal-and-botanical-supplements-continue-to-outpace-broader-market-amid-economic-uncertainty/?widget=listSection. reported that some nootropic herbs have frequently failed identity testing, including Lion’s mane. Again, this issue underscores the importance of working with a reputable and experienced CDMO that can help ensure the ingredients used in your supplement are being obtained from quality sources that can pass identity testing.
Using the right ingredient in the right form and in the right dose makes the product more likely to be effective, which leads to consumer satisfaction and a good reputation for your brand as one that produces quality products.
Likewise, using the right material at the right dose bodes well for product safety. Again, a qualified CDMO can help guide you down the path of producing a safe, efficacious and high-quality nootropic product.
Incorrect Marketing Claims
For ethical and legal reasons, it is essential to avoid making unverified or exaggerated claims about the cognitive benefits of your nootropic supplements. For example, any claims suggesting or implying that a product can treat, cure, or prevent conditions such as dementia would classify the product as an unapproved drug. This exposes companies to significant risk, including enforcement actions by the FTC, which can result in fines of $100,000 or more.
Beyond regulatory penalties, companies also face the potential for costly class action lawsuits, which can drain resources and damage long-term credibility. Even more concerning, the negative publicity associated with such claims can cause lasting harm to brand reputation.
Not surprisingly, an experienced CDMO can help you avoid unsubstantiated and unlawful claims as part of the contract manufacturing of supplements process. A trusted CDMO can help ensure that marketing language remains compliant, claims are properly substantiated, and product positioning is both responsible and legally sound.
Growing Scrutiny of Label Claims and Evidence Standards
Regulatory agencies and consumer watchdogs are placing increasing scrutiny on dietary supplement labels, particularly around the claims made about product benefits. Phrases such as “clinically proven” or “neuroprotective” are closely examined to determine whether they are adequately supported by credible scientific evidence.
To meet these higher standards, it is critical to substantiate all claims with robust data. The strongest support comes from randomized, double-blind, placebo-controlled studies conducted on the specific nutraceutical ingredients being used.
Equally important, brands must ensure that product formulations deliver a clinically relevant dose of each nootropic ingredient. Simply adding trace amounts of an ingredient (a.k.a., “fairy dusting”) without meeting levels shown effective in human studies will not withstand regulatory or market scrutiny.
By aligning claims with credible science and using proper dosages, supplement brand owners not only reduce regulatory risk but also strengthen consumer trust and brand credibility.
How Companies Can Stay Compliant
Here are some suggestions that may potentially help reduce your regulatory risk (although you should always check with your own regulatory counsel for qualified legal advice).
Invest in R&D and Clinical Validation
There are two ways you can go about effectively substantiating your nootropic product claims: conduct your own clinical trials, and/or rely on published clinical trials of the nootropic ingredients.
Certainly, the strongest position for claim substantiation is to work with a clinical research organization (CRO) to conduct a study on your finished product. Of course, clinical studies can be expensive, although there are some decentralized models using scientifically validated questionnaires that are more cost-effective than traditional models. Having your own study provides the greatest credibility and safety data for your product.
Alternatively, the use of existing published studies is the most common method for substantiating claims. In this case, you would use the same nootropic ingredient at the same dose as in the study. This would allow you to use the study to validate your claims and safety for your product.
A reputable CDMO can help provide you with resources for either option as part of the dietary supplements contract manufacturing process.
Truthful Claims, Backed by Science and Transparent Labeling
Having scientific support for your claims is only the first step. It is equally important that claims are truthful, balanced, and not overstated. For instance, if a clinical study demonstrated modest cognitive benefits for a specific nutraceutical ingredient, it would be misleading to advertise it as delivering “outstanding cognitive improvements.”
In addition to claim accuracy, make sure to use structure/function compliant language. For example, a compliant structure/function claim might be, “Supports cognitive function.” Conversely, a statement like “Corrects your forgetful memory” is non-compliant, as it both exaggerates results and implies treatment of a medical condition, which crosses into unapproved drug claim territory.
Finally, transparent labeling is critical. This includes:
- Clearly identifying all ingredients and their dosages
- Ensuring labeling reflects clinically relevant amounts
- Disclosing any known potential side effects or cautions
Taken together, these practices not only reduce regulatory risk but also strengthen consumer trust, supporting long-term brand credibility in the competitive nootropics market.
Prioritize Third-Party Testing
Third-party testing is one of the most effective ways to verify the identity, purity, and potency of nutraceutical ingredients in dietary supplements. While many CDMOs operate their own in-house testing laboratories, independent third-party verification provides additional credibility and reassurance for both regulators and consumers.
Beyond testing, third-party certifications further demonstrate a commitment to quality. Among the most important are:
- GMP Certification (NSF preferred): Confirms the CDMO has been audited and complies with Good Manufacturing Practice standards as outlined in federal regulations.
- NSF Certified for Sport: A highly regarded credential that demonstrates products are tested for banned substances and meet elevated quality standards, valued especially in the athletic community.
- FSSC 22000 Certification: A globally recognized food safety standard, less common in the supplement industry, but a strong indicator of world-class safety and regulatory compliance.
When it comes to supplement contract manufacturing, these qualifications provide peace of mind that your partner maintains the highest standards in quality, safety, and compliance.
Stay Updated on Regulations and Educate Consumers
As a brand owner in the dietary supplement industry, staying informed about evolving regulations and compliance requirements is essential for long-term success. Effective ways to accomplish this include:
- Maintaining regular communication with your CDMO regarding compliance updates
- Reading industry trade publications such as Vitamin Retailer, Nutraceuticals World, and WholeFoods Magazine
- Joining industry trade organizations like UNPA, NPA, or CRN for ongoing regulatory and market insights
Equally important is consumer education. Transparent communication about safe use, recommended dosages, and realistic expectations builds trust. For example, if research indicates a nootropic ingredient requires consistent use for at least two months to demonstrate benefits, conveying this clearly can prevent premature dissatisfaction.
Conclusion
In this blog article, we addressed the popularity of nootropics and answered the question, “Are nootropics legal?” We also examined how these ingredients are regulated both domestically and internationally and highlighted the distinctions between dietary supplement ingredients and pharmaceutical compounds, along with the risks associated with non-compliance.
For brand owners, the path to success in this category lies in navigating regulatory frameworks responsibly, substantiating claims with credible science, and maintaining rigorous standards for safety, quality, and transparency. Partnering with an experienced CDMO, such as Vitaquest, can provide invaluable guidance, whether through global regulatory expertise, clinical validation support, or adherence to third-party certifications.
By prioritizing compliance and consumer trust, companies can position themselves as credible leaders in the nootropics category and build brands capable of thriving in a competitive, highly scrutinized market.
Are you ready to “Deliver What’s Next” in nootropics supplements? Call 800-526-9095 to speak with one of our knowledgeable production specialists or request a nutraceutical manufacturing price quote if you’ve already finalized your project requirements!
Frequently Asked Questions About Nootropics
What are the risks of selling nootropics without proper regulatory approval?
The Federal Food, Drug, and Cosmetic Act (the FD&C Act) requires a person or firm that markets a dietary supplement with certain types of claims in the product labeling to notify the FDA about the claim within 30 days after first marketing the dietary supplement with the claim. The labeling claims covered by the notification requirement include structure/function claims. If you elect not to do so, you increase your risk of going to market with a claim that may not be compliant with the regulations.
Do I need third-party testing for nootropics?
As a brand owner, you are required to test your dietary supplement (nootropics or otherwise) for content and safety (e.g., heavy metals, micro). Those tests can be conducted at a third-party laboratory or at your contract manufacturer’s internal laboratory.
How do I know which nootropics are classified as dietary supplements?
Herbs and other natural ingredients are the type of nootropics found in dietary supplements. Some prescription drugs are certainly not nootropics. If you are a supplement brand owner, you can consult with your contract manufacturer for more specific information.
What certifications or quality standards improve consumer trust in nootropic brands?
The most important certification is third-party GMP certification by NSF. This certification is verification that the contract manufacturer making the product adheres to quality standards as explained in the Dietary Supplement Health and Education Act (DSHEA) of 1994.
How often do regulations for nootropics change, and how can I stay updated?
The regulations for nootropic supplements are the same as for any dietary supplements. The best way to stay updated is to read dietary supplement industry trade publications (e.g., Vitamin Retailer), join an industry trade organization (e.g., UNPA), and/or consult with your dietary supplement contract manufacturer.
Are there marketing restrictions on how I can promote nootropics?
There are regulatory restrictions on how you can market any dietary supplement. Your best source of information for this is the free, downloadable document from the FTC, Dietary Supplements: An Advertising Guide for Industry.
Can contract manufacturing companies help with regulatory compliance?
Yes, to some extent. Contract manufacturers can help with label compliance. Nevertheless, you are well advised to work with regulatory counsel for advice on all marketing claims, as well as label review.
