Yes — MoCRA (Modernization of Cosmetics Regulation Act of 2022) covers CBD topicals like salves, balms, and lotions. As of July 2025, every facility must register with the FDA, list each product, substantiate safety, and report serious adverse events within 15 business days. Drug-style claims like "pain relief" or "heals eczema" can reclassify a product as an unapproved drug.

MoCRA at a Glance: Why 2025 Is a Pivotal Compliance Year

As of January 2025, MoCRA represents the most sweeping U.S. federal reform for cosmetics since 1938. All cosmetic products, including CBD topicals like salves, balms, lotions, massage oils, and beauty creams, are subject to:

• Facility registration (initial and biennial renewal)
• Product listing and ingredient reporting
• Safety substantiation
• Adverse event tracking and reporting
• Modernized labeling requirements

For the FDA's official resources and the latest guidance, see the FDA's Cosmetics Registration & Listing information.

Key 2025 Deadlines & Current FDA Actions

• Facility registration and product listing deadline: The FDA required all responsible persons and facilities (domestic and foreign) that manufacture or process cosmetics—including CBD topicals—to register and list products by July 1, 2025.
• FDA began active industry outreach and monitoring in Q1 2025, reviewing listing data and sending advisories for non-compliance.
• Updated guidance for electronic submissions was published in early 2025, enabling smoother facility and product onboarding.

Failure to register or list products may result in FDA enforcement actions, import alerts, or market withdrawal.

Facility Registration & Product Listing: What CBD Brands Must Do Now

Facility Registration

Every facility manufacturing or processing CBD topicals must:

• Register with the FDA, disclosing business name, address, all owned/operated facilities, and responsible party information.
• Renew registration every 2 years, keeping details up to date.

Product Listing

For each CBD topical in commerce as of July 1, 2025, firms must:

• Submit product identity, label images, ingredient lists, and responsible person information via the FDA Cosmetics Product Facility Registration and Product Listing (CPFRPL) portal.
• Update listings when new products launch or discontinue.

Sound complex? CannabisRegulations.ai offers tailored support for navigating and tracking MoCRA requirements.

Safety Substantiation: What Satisfies MoCRA for CBD Topicals?

MoCRA requires that every cosmetic product—CBD-infused or otherwise—must have adequate safety substantiation before marketing. The FDA expects evidence such as:

• Published studies, toxicology data, and safety reviews of product ingredients
• IRB-approved (or scientifically valid) clinical or consumer safety testing
• Historical product safety data if formula and use are substantially unchanged
• Absence of unapproved color additives or unsafe substances (CBD itself is not an FDA-approved color, but typically does not require such approval in topicals used as cosmetics)

Firms making "drug-style" claims—such as pain relief, anti-inflammation, or healing—face heightened risk: Product may be considered an unapproved drug, not a cosmetic, risking dual FDA and FTC enforcement.

Safe Cosmetic, Not a Drug: Claim Matters

CBD is NOT automatically a drug or unapproved color additive under MoCRA—but the claims on packaging and marketing are determinative.

• Cosmetic claims (e.g., "moisturizes skin," "soothes dry hands") are subject to MoCRA's safety substantiation and labeling rules.
• Therapeutic/drug claims (e.g., "treats arthritis pain," "heals eczema") risk reclassification and immediate warning letters.

See NORML's cannabis product FDA enforcement tracker for recent actions.

MoCRA-Compliant Labeling: 2025 CBD Topicals Checklist

All CBD topical product labels distributed in the U.S. after July 1, 2025, must include:

• Contact information for adverse event reporting: phone, email, or address of the responsible person.
• Ingredient list: Ordered in descending concentration.
• Directions for safe use and any necessary warnings (especially for products intended for professional use).
• Accurate identity and net quantity declaration.

Products labeled with inadequate, incomplete, or misleading information invite regulatory risk and marketplace withdrawal.

Professional Use Requirement

If a CBD topical is only for licensed professional use (e.g., massage parlors, esthetic clinics), this must be clearly identified on the outer packaging.

Adverse Event Reporting: Setting Up 15-Day Workflows

Serious adverse event reporting is now a federal obligation for all cosmetic companies—including those selling CBD topicals. Requirements include:

• Responsible person (e.g., brand owner/manufacturer) must notify FDA of any serious adverse event (hospitalization, persistent harm, etc.) within 15 business days.
• Maintain records of all adverse events (including non-serious) for up to 6 years.

Building Compliance Workflows

• Designate an in-house or partnered point of contact for adverse events.
• Establish reporting SOPs to meet FDA's 15-day timeline.
• Leverage CRM or compliance tracking software to ensure timely, documented responses.

Learn more about adverse event reporting and how it applies to your business on the FDA website.

Enforcement Environment: What FDA Is Watching in 2025

The FDA is actively monitoring market compliance—and this includes CBD topicals:

• Review of product listings for completeness and label accuracy
• Outreach to non-registered non-listed businesses
• Spot checks on claims—especially for drug-style marketing or unsubstantiated safety
• Import alerts for foreign products not registered/listed

FTC is also aligning with FDA on deceptive or unsubstantiated claims, particularly for CBD-infused products.

Risks, Penalties, and Best Practices

• Non-compliance may lead to FDA warning letters, public notices, product seizures, or forced recalls.
• Non-registered products are subject to marketplace withdrawal and may be barred from import.
• Inadequate safety evidence, poor recordkeeping, or failure to report events can increase liability.

Key Takeaways for CBD Topical Brands and Distributors

• Register your facility and list all marketed products with the FDA right away—especially for any hemp/CBD topicals.
• Audit all product labels to confirm contact info, ingredient order, and clear use directions.
• Document safety substantiation for each formula—CBD is not a special exemption under MoCRA.
• Build a workflow for serious adverse event reporting within the FDA's 15-day rule.
• Avoid drug claims unless pursuing drug approval—"cosmetic" status provides important regulatory advantages, if strictly maintained.
• Monitor regulatory updates frequently, as guidance and enforcement approaches are evolving rapidly in 2025.

Still have questions? CannabisRegulations.ai provides tools, templates, and expert updates to help you navigate MoCRA, FDA, and state-by-state cannabis product obligations.

Stay compliant, stay competitive—make 2025 your year of regulatory clarity.