CBD FDA Rules: What’s Allowed & What’s Under Review

Where CBD FDA Rules Stand Today

At the federal level, the Food and Drug Administration (FDA) regulates how CBD can be marketed, labeled, and sold. The cannabis plant is no longer uniformly illegal—hemp (with ≤0.3% delta‑9 THC) is legal to grow and sell. But how CBD is added to products, and what you can say about those products, is still tightly controlled.

• Legal and allowed: One FDA‑approved prescription drug (Epidiolex). Certain cosmetics with CBD if they meet safety and labeling rules and make no drug claims.
• Not allowed under federal law: Adding CBD to foods and beverages for interstate commerce; marketing CBD as a dietary supplement.
• Under review: FDA has asked Congress for a new regulatory pathway for CBD, signaling potential future change.

What’s Allowed Right Now

FDA‑Approved Drug Products (Epidiolex)

The FDA has approved Epidiolex (cannabidiol) as a prescription drug for specific seizure disorders. Because CBD is the active ingredient in an approved drug and was previously studied as a drug, federal law blocks CBD from being marketed as an ingredient in conventional foods or dietary supplements (the “drug exclusion” rule).

Cosmetics Containing CBD (Limited and Claim‑Restricted)

Cosmetics—like lotions or serums—may include hemp‑derived CBD if they are not adulterated or misbranded, and if you avoid drug claims (for example, “treats pain,” “reduces inflammation,” or “heals eczema”). Cosmetic claims must be about appearance or cleansing, not disease treatment.

• Follow cosmetic GMPs and ensure product safety.
• No medical or therapeutic claims in labeling, websites, or ads.
• Disclose ingredients properly and track adverse events.

Hemp Seed Ingredients Are GRAS (But Not CBD)

Hemp seed oil, hulled hemp seed, and hemp seed protein have “Generally Recognized as Safe” (GRAS) notices for use in foods. These ingredients contain negligible CBD and are not the same as CBD extracts.

State‑Level Sales Don’t Override FDA

Some states allow CBD foods or supplements, but state permissions don’t change federal restrictions for interstate commerce. Retailers and brands should understand both state and federal requirements.

What’s Not Allowed or Under Review

CBD in Foods and Beverages

Under current food regulations, CBD cannot be added to conventional foods or drinks sold in interstate commerce. You’ll still see such products on shelves, but they operate at regulatory risk, and the FDA has issued warning letters over unapproved and misbranded products.

CBD as Dietary Supplements

Because of the drug exclusion rule, CBD cannot be marketed as a dietary supplement. New Dietary Ingredient (NDI) notifications for CBD have not resolved this barrier. Be cautious with “supplement rules” discussions online—CBD is not a lawful dietary supplement ingredient under federal law at this time.

Animal Food and Veterinary Products

The FDA has not approved CBD for use in animal food or as a veterinary drug. Claims that CBD treats pet diseases or conditions can prompt enforcement. Some states have pilot programs, but federal restrictions still apply.

Novel and Intoxicating Hemp Cannabinoids

Compounds like delta‑8 THC and other intoxicating hemp derivatives face increased scrutiny. The FDA and states have raised safety and labeling concerns, especially regarding youth access, accidental ingestion, and contamination.

What’s Under Review

In January 2023, the FDA announced that the current framework is not appropriate for CBD and asked Congress to create a new pathway. Several bills have been introduced, but no new federal law has passed yet. Until then, the status quo holds: no CBD in foods or dietary supplements for interstate commerce.

Practical Compliance Checklist (Step‑by‑Step)

Use this checklist to reduce risk and build stronger FDA compliance into your operations.

1. Define your product category: Cosmetic, drug, or something else? Avoid foods/supplements with CBD in interstate commerce.
2. Claims audit: Remove disease or therapeutic claims (on labels, websites, social media, testimonials, and metadata).
3. Quality systems: Implement GMPs appropriate to your category and maintain written SOPs.
4. Testing: Require ISO‑accredited lab COAs per batch for cannabinoids, potency, residual solvents, pesticides, heavy metals, microbials, and mycotoxins.
5. Label accuracy: Match CBD content to label claims; add batch/lot IDs, net quantity, ingredient list, and company contact.
6. Adverse event tracking: Monitor and document complaints; escalate serious events.
7. Age gates and access controls: Especially for intoxicating cannabinoids; verify local/state restrictions.
8. State licensing: Check your state’s hemp and cosmetic registrations, taxes, and shipping rules.
9. Retailer readiness: Provide COAs, product specs, and a compliance packet for buyers and marketplaces.
10. Legal review: Engage counsel to evaluate federal/state risk and marketing language before launch.

Real‑Life Example: How One Startup Reduced Risk

River & Sage Botanicals, a small skincare brand, planned to launch a CBD face serum nationwide. After a claims audit, they removed phrases like “anti‑inflammatory” and “treats acne,” shifted to cosmetic language (“soothes,” “hydrates,” “improves the look of redness”), and added batch‑specific QR codes linking to COAs.

They moved manufacturing to a facility with cosmetic GMPs, introduced adverse event tracking, and trained customer support on compliant language. Within three months, two national retailers accepted their line—on the condition that no disease claims appeared on packaging or online. The brand grew while lowering regulatory risk.

Labeling and Claims: What You Can and Can’t Say

• Do: Use cosmetic‑appropriate language: “moisturizes,” “softens,” “refreshes,” “helps skin feel calm.”
• Don’t: Claim to diagnose, cure, mitigate, treat, or prevent diseases or conditions.
• Be careful with testimonials: Customer reviews implying medical benefits can be treated as your claims if you host them.
• Be precise: If you list milligrams of CBD, verify it with batch COAs and match serving/usage directions.

Safety, Quality, and Testing Essentials

CBD products vary widely in quality. To protect consumers and reduce risk:

• Test every lot for potency and purity; verify delta‑9 THC compliance (≤0.3% for hemp).
• Screen for pesticides, heavy metals, residual solvents, microbials, and mycotoxins.
• Avoid products making drug‑like claims or lacking third‑party COAs.
• Consider drug interactions (CYP450), drowsiness, and liver warnings; consult a healthcare professional if pregnant, nursing, or taking medications.

Preparing for Future Changes

Even though federal law hasn’t shifted yet, you can get ready:

• Document safety data (stability, toxicology summaries, consumer complaints).
• Maintain transparent supply chains and traceability.
• Monitor FDA updates, Congressional bills, and state rules.
• Stay nimble—design labels and websites that can be updated quickly if rules change.

Frequently Asked Questions

Conclusion

The bottom line on CBD FDA rules: CBD cannot be added to foods or marketed as a dietary supplement in interstate commerce, and cosmetic products must avoid drug claims and ensure safety. The FDA has asked Congress for a new pathway, but until laws change, the safest strategy is careful compliance and conservative claims.