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How recent FDA actions and warning letters affect CBD shoppers — fda cbd warning letters
Recent FDA actions and warning letters have shifted the CBD marketplace. This guide explains what those letters mean for shoppers and how to reduce risk when buying CBD online.
By the BuyLegalMeds team14 min read
Key takeaways
- FDA warning letters are targeted at companies that make illegal medical claims or otherwise break the FD&C Act.
- Shoppers should watch for disease or treatment claims, unsupported ingredient statements, and products marketed as foods or supplements when prohibited.
- Certificates of Analysis (COAs) and clear labeling reduce risk but do not replace regulatory compliance.
- If you find a product making disease claims, save evidence and report it to FDA; avoid buying if claims suggest drug use.
- Ongoing CBD regulation in 2024 means enforcement priorities may change; stay informed through FDA resources.
Quick overview: what this guide covers
This article explains how fda cbd warning letters shape the online CBD market, what triggers agency action, and practical steps shoppers can take to reduce risk when buying hemp-derived products. It focuses on enforcement trends, how to spot illegal claims, and which labels or documents (like Certificates of Analysis) add trustworthiness.
Why the FDA issues warning letters about CBD and cannabis-derived products
The U.S. Food and Drug Administration enforces the Federal Food, Drug, and Cosmetic Act (FD&C Act). When companies market products containing cannabis-derived compounds — including cannabidiol (CBD) — in ways the agency has not authorized, FDA may send warning letters. These letters notify firms that their labeling or marketing may make a product an unapproved drug, an adulterated food, or a misbranded product.
FDA uses warning letters to communicate specific violations and to request corrective action. The letters can cover a range of issues from disease claims and unapproved drug marketing to adding CBD to foods or marketing products as dietary supplements when those products do not meet the law's criteria.
For shoppers, a warning letter indicates the agency found statements or product placements that overstep legal boundaries. The letters are not consumer safety recall notices in every case, but they flag significant regulatory concerns and commonly result from the same types of risky marketing.
How FDA defines impermissible marketing for CBD
FDA evaluates a product’s marketing based on the product’s intended use. Intended use can be inferred from labeling, claims on company websites, social media posts, and other promotional materials. If a company markets a CBD product with claims that it can diagnose, prevent, treat, or cure a disease, FDA can consider that product an unapproved new drug.
FDA has said that, aside from certain prescription medicines that underwent FDA review, CBD is not an approved ingredient for general foods or dietary supplements. The agency has concluded that CBD is excluded from the dietary supplement definition because it is the active ingredient in an FDA-approved drug (Epidiolex) and has been the subject of substantial clinical investigations.
What “unapproved new drug” means for a marketed CBD product
When a product is marketed with therapeutic claims (for example, that it helps with a particular medical condition), the product may meet the statutory definition of a drug. Drugs must generally undergo FDA premarket review and approval to be lawfully marketed. If a CBD product is promoted as a drug without FDA approval for that use, the product is considered an unapproved new drug — and FDA warnings or enforcement may follow.
How food and supplement rules apply
Adding CBD to conventional foods is legally risky because CBD is not an approved food additive and FDA has not found it to be Generally Recognized as Safe (GRAS) for use in foods. Similarly, companies should not market CBD as a dietary supplement because of exclusions in the law. These rules are the reason FDA has cited firms for marketing CBD-infused foods and beverages.
Enforcement beyond warning letters
A warning letter is one enforcement tool. If companies fail to address FDA concerns, the agency can pursue seizures, injunctions, or other legal actions. The agency also works with state partners and consumer protection authorities when appropriate.
What kinds of CBD marketing trigger FDA warning letters? (short answer for shoppers)
In plain terms, the common reasons FDA issues warning letters include:
- Claims that a product prevents, treats, or cures diseases, or makes therapeutic promises without FDA approval.
- Marketing a CBD product as a dietary supplement when it is excluded from that category under federal law.
- Adding CBD to foods or beverages without FDA authorization.
- Misbranding that creates safety concerns, such as missing or misleading ingredient information or inadequate directions when a product is effectively being promoted as a drug.
- Marketing products for use in animals as animal drugs without approval, especially for food-producing animals where residues could affect the food supply.
These categories come directly from FDA guidance and the agency’s public list of warning letters for cannabis-derived products.
What FDA warning letters for CBD mean for online shoppers
When FDA sends warning letters, the immediate marketplace effect can vary. Some companies remove or change product pages and marketing materials quickly. Others dispute findings or take longer to comply. For shoppers, the practical outcomes include changes in product descriptions, temporary removal of certain items, or continued availability of products with revised claims.
Shoppers should see warning letters as signals to be more cautious about claims and to pay closer attention to labeling and lab testing documentation. A company that receives a warning letter is required to respond, and some changes may follow; however, the presence or absence of a warning letter on a company does not necessarily mean a product is safe or unsafe.
How enforcement trends affect product availability
Enforcement tends to focus on companies making clear medical claims or adding CBD to foods and supplements in ways FDA has said are not permitted. That means products marketed primarily as wellness items with neutral language, clear lab testing, and compliant labeling are less likely to draw agency attention — though this is not a guarantee of safety.
Examples and patterns from recent FDA actions
FDA’s public list of warning letters shows repeated themes: marketing CBD products as treatments, adding CBD to conventional foods, and claiming unproven benefits. The agency also has pursued firms that market CBD products intended for animals, especially food-producing animals, where human safety could be affected by residues.
These patterns make it important for shoppers to prioritize transparency and documentation when evaluating online sellers.
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How to spot illegal claims and risky marketing language
Learning a few red flags will help you spot problematic marketing quickly. These are the phrases and formats that commonly indicate a product is being marketed outside FDA rules:
- Direct disease claims: phrases like "treats arthritis," "reduces anxiety disorder," "cures cancer," or other statements that promise diagnosis, cure, mitigation, or prevention.
- Specific dosing guidance for treating illnesses or comparisons to prescription medicines.
- Language that rebrands a CBD product as a dietary supplement when the product is clearly promoted as therapeutic.
- Food-like presentations that mask medicinal claims (for example, CBD in candy or beverages with medical language in promotional copy).
- Testimonials or influencer statements framed as medical advice without research backing.
If you see these on product pages, assume the company is taking regulatory risk and consider alternatives with more cautious language.
Distinguishing label facts from marketing copy
Label facts — ingredient lists, serving size, amount of CBD per serving, and manufacturer contact — are useful. Marketing copy is everything else on the product page or promotional materials. When marketing claims cross into treatment language, the product may be unlawfully positioned as a drug.
When “natural” or “clinically tested” claims are problematic
Terms like "natural," "clinically tested," or "research-backed" are not illegal per se, but they must be truthful and not misleading. If a product claims to be "clinically tested" but presents no verifiable studies, that is a consumer-protection concern. Similarly, a claim that a product is "safe for children" would be a red flag without sound evidence and appropriate regulatory approvals.
Documents, labels, and lab reports that reduce buyer risk
No single document guarantees legal compliance, but a set of clear, verifiable items helps shoppers make more informed choices. Look for:
- A Certificate of Analysis (COA) from an ISO/IEC 17025–accredited third-party lab when available. The COA should match the product batch and list cannabinoid potency and contaminants tested.
- Clear ingredient lists and declaration of CBD amount per serving or per package.
- Transparent manufacturer contact information and a physical address.
- Honest marketing language that avoids disease or treatment claims and uses phrases like "some people use" or "for general wellness" rather than therapeutic promises.
- Clear animal-use instructions for pet products, with explicit warnings when data are limited.
When a COA is provided, verify that the lab name is visible, the testing date and batch number match the product, and tests include cannabinoid potency and common contaminants (pesticides, heavy metals, residual solvents, microbial limits) where relevant.
For more detail on reading lab reports, see our guide on how to read CBD lab reports for shoppers at how to read CBD lab reports.
How to evaluate product categories and formats
Different product formats pose different regulatory and practical risks.
- Tinctures and sublinguals: These are common and usually presented as wellness products. Clear potency labeling and batch COAs are particularly important for tinctures because concentration per milliliter matters to shoppers.
- Edibles and beverages: Adding CBD to food and drink has drawn specific FDA scrutiny. The agency has indicated that CBD is not an approved food additive, so edibles can raise legal questions. If a vendor is selling CBD in food formats, read marketing claims carefully and check for COAs.
- Topicals and cosmetics: Topical products can be lawful as cosmetics if they do not make therapeutic claims. If a topical claims to "heal" or "treat" a medical condition, FDA may view it as a drug. Clear labeling and cosmetic-appropriate language reduce regulatory risk.
- Pet products: Marketing CBD for pets has led to FDA action, especially when claims target specific animal diseases or when products are used in food-producing animals. Look for products with explicit disclaimers and transparent testing for pet-specific formulations. Consider our pet collection for options presented for animal use at CBD for pets.
- Vapes and inhalables: These formats can be concentrated and carry different safety considerations. Product transparency and lab testing are especially relevant.
For shoppers browsing by category, our collections pages can help you compare product presentations and labeling standards. Explore tinctures at CBD tinctures or syrups at CBD syrup.
Practical shopping checklist: how to avoid CBD products with illegal medical claims
Follow this checklist when you evaluate an online CBD product:
- Read the main product description and the fine print. If you see disease language or promises of recovery, do not buy.
- Look for a batch-specific COA from a reputable lab. Check the lab name and accreditation and ensure dates and lot numbers line up.
- Verify the CBD amount is clearly listed per serving and per package.
- Confirm there’s a visible, working phone number and physical address for the company.
- Check that marketing language uses cautious words like "some people use" rather than medical promises.
- Avoid products presented as dietary supplements or conventional food with CBD unless the vendor explains compliance and provides robust testing and legal disclosures.
- For pet products, prefer vendors who explicitly state limits of the evidence and avoid products promising to treat animal diseases.
If you want product examples from trusted, transparent listings, see our featured tinctures at ACTIV8 CBD Tincture and browse all options at All products to compare labels and testing documentation.
What to do if a product makes disease claims: steps for shoppers
If you encounter a product marketed with disease or treatment claims, take these steps:
- Save evidence: take screenshots of the product page, marketing emails, and social posts. Note dates and URLs.
- Do not purchase the product if the claims suggest drug use or promise specific results.
- Report the product and your evidence to FDA’s MedWatch or the agency’s reporting portal for consumer complaints about CBD and cannabis-derived products. FDA uses consumer reports as part of its enforcement work.
- If the product caused an adverse event, consult a healthcare professional, and report the event to FDA’s safety reporting system.
Reporting helps regulators identify patterns and protect other consumers. FDA’s public pages explain how the agency regulates cannabis-derived products and why certain claims trigger action; see FDA’s overview on regulation of cannabis-derived products for background and reporting guidance.
What shoppers should expect from CBD regulation in 2024 and beyond
CBD regulation is in flux and has been a focus of FDA public statements and enforcement. The agency has emphasized that current frameworks for foods and dietary supplements are not appropriate for CBD and that Congress and FDA may need to work on new regulatory pathways. Meanwhile, the agency continues to monitor the market and take enforcement actions when it identifies violations.
Shoppers should expect continued enforcement focused on clear disease claims and unauthorized use of CBD in foods or supplements. At the same time, vendors that prioritize transparent labeling, provide batch COAs, and use compliant language are less likely to attract regulatory attention.
The role of congressional and regulatory change
FDA has acknowledged limits in the current statutory framework for CBD and mentioned working with Congress on approaches that could provide clarity for industry and consumers. Any legislative or regulatory changes would likely take time, so buyers should continue using careful evaluation practices.
Consumer protection: beyond FDA — other safety steps
Regulation is one part of safety. Consumers also benefit from independent research, community reviews, and third-party testing. When evaluating vendors, consider:
- Independent reviews and reputation among consumers.
- Availability of customer service to answer batch- or safety-related questions.
- Transparent return policies that allow you to avoid continuing payments for products that don’t meet your expectations.
Our guidance on how to choose quality CBD products online summarizes many of these practical checks and can be found at how to choose quality CBD products online.
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How retailers (and responsible manufacturers) respond to warning letters
When FDA issues a warning letter, responsible companies typically do the following:
- Remove or revise marketing content that made impermissible claims.
- Update product pages to remove drug-like language and to clarify intended use.
- Provide batch-matching COAs and increase transparency about testing practices.
- Engage legal or regulatory counsel to respond formally to FDA and to describe corrective actions.
These actions may restore compliance, but they do not retroactively authorize prior claims or packaging. Consumers should look for evidence that a vendor has made the requested changes and consider whether the vendor’s transparency improved after the letter.
Final checklist and quick tips for safe shopping
- Never trust claims that sound too good to be true. Promises to prevent or cure illnesses are red flags.
- Look for COAs tied to the product lot. If you can’t find them, ask the seller directly for lab documentation.
- Prefer companies that use cautious language and disclose testing for contaminants as well as cannabinoid potency.
- Save web pages and communications if you suspect illegal marketing. You can report these to FDA.
- Prioritize vendors that offer clear contact information and robust return policies.
Closing thoughts
FDA warning letters are an important consumer-protection tool. For shoppers, they are a cue to pay closer attention to marketing language, lab testing, and labeling transparency. While regulation continues to evolve in 2024 and beyond, sellers who prioritize clear, non‑therapeutic language and robust third‑party testing help buyers reduce risk.
If you want specific product ideas that pair clear labeling with transparent testing policies, start by comparing tinctures in our CBD tinctures and check product pages for batch COAs and manufacturer contacts before you buy.
FAQ
What kinds of CBD marketing trigger FDA warning letters?
FDA warning letters typically target marketing that claims a CBD product prevents, treats, or cures a disease, or that otherwise positions the product as a drug without FDA approval. Marketing CBD as a dietary supplement or adding CBD to conventional foods in ways that skirt food additive rules has also resulted in warning letters. These findings are based on FDA’s enforcement descriptions and the agency’s public list of warning letters.
How should shoppers respond if a product makes disease claims?
If a product makes disease or treatment claims, do not buy it. Save screenshots and URLs as evidence, and file a report with the FDA. If you experienced an adverse event, consult a healthcare professional and report the incident through FDA’s safety reporting channels. Reporting helps regulators and protects other consumers.
Which product labels and documents reduce risk when buying online?
Look for clear ingredient lists, batch-specific Certificates of Analysis (COAs) from reputable labs, labeled CBD amounts per serving and per package, and transparent contact information for the manufacturer. COAs that list cannabinoid potency and tests for common contaminants (pesticides, heavy metals, solvents, microbial limits) are particularly helpful.
Are testimonials and influencer posts reliable indicators of product safety?
Testimonials and influencer posts are not a substitute for verifiable testing or compliance. They may describe personal experiences but do not prove safety or regulatory compliance. Always verify third-party lab results and check that the seller avoids unlawful claims.
Can CBD be sold in foods or as dietary supplements?
FDA has stated that CBD is not an approved food additive and has concluded that CBD is excluded from the dietary supplement definition under current statutory provisions. As a result, adding CBD to conventional foods or marketing it as a dietary supplement can create legal risks, and FDA has issued warnings related to these practices.
Where can I learn more about how FDA regulates CBD and find warning letters?
FDA’s pages on "FDA Regulation of Cannabis and Cannabis‑Derived Products, including Cannabidiol (CBD)" and the agency’s public list of "Warning Letters for Cannabis‑Derived Products" lay out the agency’s current positions and the specific warning letters it has issued. These are primary sources for understanding recent enforcement.
References
- FDA, "FDA Regulation of Cannabis and Cannabis‑Derived Products, including Cannabidiol (CBD)", U.S. Food and Drug Administration. https://www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-products-including-cannabidiol-cbd
- FDA, "Warning Letters for Cannabis‑Derived Products", U.S. Food and Drug Administration. https://www.fda.gov/news-events/public-health-focus/warning-letters-cannabis-derived-products
- FDA, "FDA Issues Warning Letters to Companies Illegally Selling CBD and Delta-8 THC Products" (May 4, 2022 press announcement). https://www.fda.gov/news-events/press-announcements/fda-issues-warning-letters-companies-illegally-selling-cbd-and-delta-8-thc-products
- FDA, "Discover Health, LLC d/b/a Discover CBD and Strain Snobs — Warning Letter (Nov 16, 2023)". https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/discover-health-llc-dba-discover-cbd-and-strain-snobs-661488-11162023
Early product highlights
This article showed featured products earlier to help shoppers compare clear labeling and transparent listings. For more product categories, explore our collections and product pages linked above.
Frequently asked questions
What kinds of CBD marketing trigger FDA warning letters?
FDA typically issues warning letters for marketing that claims a CBD product prevents, treats, or cures disease, for marketing CBD as a dietary supplement when excluded by law, and for adding CBD to conventional foods without authorization. These categories reflect the agency’s public enforcement priorities.
How should shoppers respond if a product makes disease claims?
Do not purchase products that make disease-treatment claims. Save screenshots and URLs as evidence and report the product to FDA. If you have an adverse reaction, seek medical advice and report the event to FDA’s safety reporting system.
Which product labels and documents reduce risk when buying online?
Prefer products with batch-specific Certificates of Analysis (COAs) from accredited labs, clear ingredient lists, explicit CBD amounts per serving, and transparent manufacturer contact information. COAs that test for potency and common contaminants are especially useful.
Are CBD products allowed in foods or as dietary supplements?
FDA has stated that CBD is not an approved food additive and has concluded that CBD is excluded from the dietary supplement definition under current federal law, which creates legal risks for foods and supplements containing CBD.
How can I verify a Certificate of Analysis (COA)?
Check that the COA lists a testing lab with verifiable credentials, an accreditation standard (such as ISO/IEC 17025 where available), a test date and batch number that matches the product, and tests for cannabinoid potency plus common contaminants.
References
- FDA Regulation of Cannabis and Cannabis‑Derived Products, including Cannabidiol (CBD) (opens in a new tab). U.S. Food and Drug Administration.
- Warning Letters for Cannabis‑Derived Products (opens in a new tab). U.S. Food and Drug Administration.
- FDA Issues Warning Letters to Companies Illegally Selling CBD and Delta-8 THC Products (opens in a new tab). U.S. Food and Drug Administration.
- Discover Health, LLC d/b/a Discover CBD and Strain Snobs — Warning Letter (Nov 16, 2023) (opens in a new tab). U.S. Food and Drug Administration.
These statements have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure, or prevent any disease. This article is for general education only and is not medical advice. Talk with a qualified healthcare professional before using any new product, especially if you are pregnant, nursing, or take medication.
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