Category: FDA Compliance

If you sell cosmetics in the United States — whether you are a domestic brand, a foreign manufacturer, or a contract manufacturer — there is a significant chance you are now subject to federal requirements that did not exist three years ago. The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the most sweeping overhaul of U.S. cosmetics law since the Federal Food, Drug, and Cosmetic Act was passed in 1938. And unlike most regulatory updates, MoCRA created entirely new obligations — not just refinements of existing ones.

This guide explains what MoCRA is, what it requires, who it applies to, and what happens if you are not yet in compliance.

Why MoCRA Was Passed

For most of the 20th century, the FDA had remarkably limited authority over cosmetics. Unlike drugs, dietary supplements, or food, cosmetics did not require pre-market approval or registration. The FDA could take action against unsafe cosmetics after the fact — but it had no formal mechanism to require facility registration, product listing, or mandatory safety testing before a product reached consumers.

MoCRA changed that. Passed as part of the Consolidated Appropriations Act of 2023, MoCRA gave the FDA new authority to require cosmetics manufacturers to register their facilities, list their products, maintain safety substantiation records, report serious adverse events, and — eventually — follow binding Good Manufacturing Practices. It also gave the FDA mandatory recall authority over cosmetics for the first time in history.

What MoCRA Requires: The Five Core Obligations

1. Facility Registration

Any person who owns or operates a facility that manufactures or processes cosmetic products for distribution in the United States must register that facility with the FDA. This includes both domestic manufacturers and foreign manufacturers exporting to the U.S. Registration must be renewed every two years and updated within 60 days of any change to the registered information.

The registration deadlines have already passed. If your facility is not registered, you are currently out of compliance and subject to FDA enforcement, including import detention for foreign manufacturers.

2. Product Listing

In addition to facility registration, “responsible persons” — typically the brand owner or domestic distributor — must submit a product listing for each cosmetic product they market. The listing must include the product name, category, ingredient list (using INCI names), and the facility registration number where the product is manufactured. Product listings must be updated annually and whenever the formulation changes.

3. Serious Adverse Event Reporting

Responsible persons must report serious adverse events to the FDA within 15 business days of receiving a report. A serious adverse event is one that results in death, life-threatening injury, inpatient hospitalization, persistent disability, congenital anomaly, or requires medical intervention to prevent serious harm. Records of all adverse event reports — serious and non-serious — must be maintained for six years.

4. Safety Substantiation

MoCRA requires that cosmetic products have “adequate substantiation of safety.” The responsible person must be able to demonstrate that the product and its ingredients are safe for their intended use. While the FDA has not yet issued a formal definition of “adequate substantiation,” the obligation exists now and the FDA has authority to inspect your safety files.

5. Good Manufacturing Practices (GMP) — Coming

MoCRA requires the FDA to issue binding GMP regulations for cosmetics. These regulations are expected to align closely with the voluntary ISO 22716 GMP standard that many professional cosmetics manufacturers already follow. Once finalized, compliance will be mandatory. Companies that have invested in ISO 22716 compliance will have a significant advantage when the rules take effect.

Who Does MoCRA Apply To?

MoCRA applies to a broad range of businesses in the cosmetics supply chain:

• Domestic brands and brand owners — responsible for product listing, safety substantiation, and adverse event reporting for products they market
• Contract manufacturers — responsible for facility registration and, eventually, GMP compliance
• Foreign manufacturers exporting to the U.S. — must register their facilities with the FDA; failure to do so can result in import detention
• Private label distributors — if they are the “responsible person” for a product, they bear the product listing and adverse event reporting obligations

Small business exemption: Businesses with average annual U.S. gross sales of $1 million or less (adjusted for inflation) are exempt from facility registration. However, they are still subject to product listing, safety substantiation, adverse event reporting, and labeling requirements.

What Are the Consequences of Non-Compliance?

MoCRA significantly expanded the FDA’s enforcement authority over cosmetics:

• Warning letters: The FDA can issue warning letters citing specific MoCRA violations — including failure to register, failure to list products, or failure to report adverse events.
• Mandatory recall authority: For the first time, the FDA has statutory authority to order a mandatory cosmetics recall if it determines a product poses a reasonable probability of serious adverse health consequences. Previously, all cosmetic recalls were voluntary.
• Import detention: Foreign manufacturers that fail to register their facilities can have their products detained at the U.S. border.
• Injunction and seizure: The FDA can seek court orders to stop the distribution of non-compliant cosmetics and seize violative products.
• Civil penalties: The FDA can impose civil penalties for failure to comply with serious adverse event reporting requirements.

Common MoCRA Misconceptions

“My contract manufacturer registered — I’m covered.”

No. Facility registration is the manufacturer’s obligation. Product listing, safety substantiation, and adverse event reporting are the responsible person’s (typically the brand owner’s) obligations. These are independent duties. Your manufacturer being registered does not satisfy your product listing or adverse event reporting requirements.

“We sell on Amazon / Etsy — MoCRA doesn’t apply to online sellers.”

Wrong. MoCRA applies to any cosmetic product sold or distributed in the United States, through any channel. Third-party marketplace platforms are not a shield from FDA enforcement. If you manufacture or have products manufactured and sell them in the U.S., MoCRA applies to you.

“We haven’t received any complaints — we don’t need adverse event reporting procedures.”

The obligation to have adverse event reporting procedures in place is not triggered by receiving a complaint — it exists the moment you are a responsible person marketing a cosmetic product in the U.S. You need a system to identify, document, evaluate, and report serious adverse events before you receive one, not after.

Getting into Compliance

If your business has not yet completed MoCRA compliance, the most important next step is a structured compliance assessment. That means:

1. Determining whether your facility is registered (if required)
2. Confirming whether your products are listed with the FDA
3. Establishing an adverse event reporting procedure
4. Reviewing your safety substantiation files
5. Assessing your current manufacturing practices against ISO 22716 ahead of binding GMP requirements

Capote Law Firm has been helping cosmetics companies navigate FDA compliance since 2006. For MoCRA compliance guidance, visit our MoCRA Compliance page or call (786) 207-1174 to schedule a free consultation.

Amazon has become one of the largest distribution channels for dietary supplements and cosmetics — and one of the most demanding from a regulatory compliance standpoint. Selling supplements or cosmetics on Amazon is not simply a matter of listing a product. Amazon requires specific certifications, documentation, and labeling compliance that go beyond what federal law strictly mandates — and failing to meet Amazon’s requirements can result in listing suspensions, account deactivation, and products removed from sale with little warning.

This guide covers what dietary supplement and cosmetics brands need to know about FDA compliance and Amazon’s specific requirements before listing — and what to do if your listing has already been suspended.

FDA Compliance Is the Foundation

Before Amazon’s requirements even come into play, your products must comply with FDA regulations. For dietary supplements, that means:

• All ingredients are on the FDA’s approved dietary ingredient list or have a valid New Dietary Ingredient (NDI) notification
• The label includes all required elements: Supplement Facts panel, ingredient list, net quantity, manufacturer information, and applicable structure/function claim disclaimers
• Structure/function claims are substantiated, truthful, and do not cross the line into disease claims
• The manufacturing facility complies with 21 CFR Part 111 (cGMP for dietary supplements)
• The facility is registered with the FDA

For cosmetics, FDA compliance means:

• All ingredients are permitted for cosmetic use and are listed in INCI format on the label
• No prohibited ingredients (e.g., certain color additives without FDA approval, formaldehyde above permitted levels)
• No drug claims on a cosmetic product (e.g., claims that the product treats or prevents acne, reduces wrinkles, or lightens skin tone — these can render a cosmetic a drug)
• MoCRA compliance: facility registration, product listing, and adverse event reporting procedures in place

Amazon’s Specific Requirements for Dietary Supplements

Amazon has layered additional requirements on top of FDA regulations for dietary supplement sellers. These requirements vary by category and can change without advance notice, but common Amazon-specific requirements include:

Dietary Supplement Verification Program

Amazon requires many supplement sellers to participate in its Dietary Supplement Verification Program. This program requires sellers to submit third-party testing results confirming that the product’s label claims are accurate — that the product contains what it says it contains, in the amounts stated, and does not contain undeclared substances.

Amazon typically requires testing from an ISO 17025-accredited laboratory. The test results must be within a recent time window (typically 12 months) and must cover the specific product being listed, not just the ingredient in isolation.

Certificates of Analysis

Amazon frequently requests Certificates of Analysis (COAs) from sellers of dietary supplements. COAs from your manufacturer or from a third-party testing lab should document the identity, purity, and potency of your finished product. Sellers who cannot produce COAs on demand risk listing suspension.

Label Review

Amazon’s automated and manual review systems flag supplement labels for compliance issues including: incorrect Supplement Facts panel format, unauthorized drug claims, missing mandatory disclosures, and ingredient names that do not match FDA-approved terminology. A label that passes FDA’s technical requirements may still be flagged by Amazon’s review system if it uses non-standard formatting or terminology.

Prohibited Claims

Amazon is particularly aggressive in enforcing against disease claims on supplement listings — claims that the product treats, cures, mitigates, or prevents a specific disease or condition. Disease claims on a dietary supplement violate FDA regulations and Amazon’s policies simultaneously, and Amazon has systems specifically designed to detect them in both the product title and description.

Amazon’s Requirements for Cosmetics

Cosmetics sellers on Amazon face their own set of requirements that go beyond FDA labeling rules:

• No drug claims: Claims that a cosmetic product treats acne, reduces wrinkles by stimulating collagen production, blocks UV radiation (without OTC monograph compliance), or otherwise affects the structure or function of the body can render the product a drug — which requires different Amazon categorization, additional documentation, and potentially FDA approval that the seller cannot produce.
• Ingredient restrictions: Amazon maintains its own list of restricted and prohibited ingredients in cosmetics, which may be stricter than FDA requirements in some cases. Products containing certain preservatives, fragrances, or functional ingredients may require additional documentation.
• Safety data sheets: For some cosmetic ingredients, Amazon may request Safety Data Sheets (SDS) or ingredient safety documentation.
• MoCRA compliance: As MoCRA enforcement ramps up, Amazon is expected to increasingly verify that cosmetics sellers have completed FDA facility registration and product listing.

What Happens When Amazon Suspends Your Listing

Amazon supplement and cosmetics listing suspensions typically fall into two categories:

• Documentation requests: Amazon flags your listing and requests additional documentation (COA, test results, label images, ingredient lists). If you respond with compliant documentation within Amazon’s deadline, the listing is typically reinstated.
• Policy violation suspensions: Amazon determines that the product or listing violates a policy — most commonly, a disease claim, a prohibited ingredient, or a label compliance issue. These suspensions require correcting the underlying issue before reinstatement.

The most effective response to an Amazon listing suspension for a dietary supplement or cosmetics product starts with understanding why Amazon flagged the listing. This is not always clear from Amazon’s notification. The real reason may be a labeling issue, a claims issue, a documentation gap, or an ingredient concern — and the corrective action is different for each.

How Capote Law Firm Helps Amazon Sellers

• Pre-listing label and claims review: Before you list, we review your supplement or cosmetics label and all marketing claims for FDA compliance and Amazon policy compliance. We identify issues that will trigger suspension before you invest in inventory and listing setup.
• Amazon certification documentation support: We help you assemble the documentation Amazon requires — including COAs, test result interpretation, and label compliance letters — in the format Amazon’s verification teams expect.
• Listing suspension response: We analyze Amazon’s suspension notice, identify the underlying compliance issue, advise on corrective action, and help you draft an effective Plan of Action (POA) for reinstatement.
• Ongoing compliance: As Amazon’s requirements and FDA regulations evolve, we advise on changes that affect your listings and help you stay ahead of suspensions.

Selling dietary supplements or cosmetics on Amazon? Get a label and claims review before your listing is suspended. Call (786) 207-1174 or schedule a free consultation with Capote Law Firm.

Receiving an FDA warning letter is one of the most stressful moments a business owner or compliance officer can face. Your phone rings, an email lands in your inbox, or a package arrives from the U.S. Food & Drug Administration — and it says, in plain terms, that you have violated federal law.

The instinct is often to panic. The second instinct is sometimes to ignore it and hope it goes away. Both are mistakes.

A well-crafted, timely response to an FDA warning letter can make the difference between a matter that closes quietly and one that escalates into a product seizure, import alert, or consent decree. This guide walks you through exactly what to do — and what not to do — from the moment you receive a warning letter to the day you submit your response.

What Is an FDA Warning Letter?

An FDA warning letter is an official enforcement communication notifying a company or individual that the FDA has found what it believes to be a violation of a law it enforces — primarily the Federal Food, Drug, and Cosmetic Act (FD&C Act). Warning letters are typically issued after an inspection, a review of labeling or marketing materials, or an analysis of adverse event reports.

They are not criminal charges. They are not final regulatory decisions. But they are serious — and they are public. The FDA posts all warning letters on its website, searchable by company name, and the trade press monitors that database closely. Retailers, distributors, and investors may find your warning letter before you have responded to it.

Common violations that trigger FDA warning letters in our practice areas include:

• Dietary supplements: Unapproved drug claims (structure/function claims that cross the line into disease claims), cGMP violations under 21 CFR Part 111, undeclared ingredients, or failure to report serious adverse events
• Cosmetics: Products marketed as cosmetics that make drug claims, MoCRA non-compliance, prohibited ingredients, or misleading labeling
• Food: FSMA violations, Foreign Supplier Verification Program (FSVP) failures, undeclared allergens, misbranding
• OTC drugs: Deviations from OTC monograph requirements, labeling deficiencies, cGMP failures
• Medical devices: Marketing without required 510(k) clearance, inadequate quality system regulations, unauthorized marketing claims

The 15-Business-Day Clock Starts Now

The FDA asks for a written response within 15 business days of receipt. This is not a hard statutory deadline — there is no automatic penalty for missing it — but failing to respond within that window sends a clear message to the agency: you are not taking the matter seriously.

In practice, a slow or absent response almost always accelerates escalation. The FDA tracks warning letter responses and notes publicly when companies fail to reply or when responses are deemed inadequate. That notation becomes part of your enforcement history.

If you need more time — for example, to gather documentation or retain counsel — you can request an extension. Do this promptly and in writing, explaining why additional time is needed. The FDA typically grants reasonable extension requests when asked in good faith.

Step 1: Read the Warning Letter Carefully — All of It

This sounds obvious, but it’s worth emphasizing. Every FDA warning letter is structured around specific observations, each tied to a specific regulatory provision. Before you can respond effectively, you need to understand exactly what the FDA is alleging and the legal basis for each allegation.

For each observation, ask:

• What specific provision of law or regulation is cited?
• What specific product, label, claim, or practice prompted this observation?
• Is the observation factually accurate?
• Is the regulatory interpretation correct?
• What can we correct immediately, and what requires more time?

This analysis is the foundation of your response. If you skip it, you risk submitting a response that fails to address the FDA’s actual concerns — which is one of the most common and costly mistakes companies make.

Step 2: Triage — What Can You Fix Before You Respond?

The strongest warning letter responses are not just promises — they are records of actions already taken. Before you write a single word of your response, identify what you can correct in the next 48 to 72 hours:

• Labeling violations: Pull the offending label from circulation and update the digital version on your website immediately. Document the date of the change.
• Unauthorized claims: Remove the claim from your website, Amazon listing, social media, and any other marketing material. Take screenshots before and after.
• Ingredient or formulation issues: Quarantine the affected lot(s) pending further review.
• Facility or GMP issues: Begin corrective action on the most critical observations and document every step.

When you can tell the FDA “we identified this problem and corrected it on [specific date] — here is the documentation,” your response is dramatically more credible than “we plan to address this in the coming weeks.”

Step 3: Structure Your Response Observation by Observation

The FDA organizes its warning letters by numbered observations. Your response should mirror that structure exactly — numbered response 1 addresses observation 1, numbered response 2 addresses observation 2, and so on. This makes it easy for the FDA reviewer to confirm that you have addressed every point.

For each observation, your response should include four elements:

1. Acknowledgment: Confirm that you received and reviewed the observation. Do not simply agree with every allegation — if you believe the FDA’s interpretation is incorrect, this is where you say so (respectfully and with regulatory support).
2. Immediate corrective actions taken: Describe specifically what you have already done to address the issue, with dates. Attach supporting documentation — updated labels, revised SOPs, retaining records, lot quarantine documentation.
3. Planned corrective actions: For issues that cannot be resolved immediately, describe your corrective action plan with specific milestones and dates. Vague commitments (“we will improve our procedures”) are far less persuasive than specific ones (“we will complete retraining of all production staff by [date] and submit documentation to the FDA by [date]”).
4. Prevention: Describe what systemic changes you are making to prevent recurrence — updated procedures, new testing protocols, personnel changes, training programs.

Step 4: Attach Documentation — Everything

A response without documentation is a promise. A response with documentation is evidence. The FDA reviewer needs to be able to verify your corrective actions without taking your word for it.

Typical supporting documents include:

• Updated labels (before and after versions)
• Revised standard operating procedures (SOPs), with effective dates and author signatures
• Training records documenting who was trained, on what, and when
• Testing or laboratory results supporting ingredient or formulation claims
• Batch records or quarantine documentation for affected lots
• Screenshots or archived copies of corrected website content
• Correspondence with contract manufacturers or suppliers if applicable

Organize attachments clearly, label each exhibit, and reference them by exhibit number within the body of your response. The FDA reviewer should be able to follow your response and verify each claim without hunting through a disorganized pile of documents.

Step 5: Tone and Format Matter

Your response should be professional, specific, and factual. It should not be defensive, dismissive, or apologetic to the point of admitting violations you are not certain you committed. Some guidance on tone:

• Do not be adversarial. You may disagree with the FDA’s interpretation of a regulation — and you may be right — but the way to make that argument is with regulatory citations and reasoned analysis, not indignation.
• Do not over-apologize. Excessive apology can read as an admission of willful wrongdoing. Acknowledge the issue, explain what happened, and focus on what you are doing to correct it.
• Do not make promises you cannot keep. If you commit to a corrective action timeline, meet it. The FDA will follow up, and a broken promise is worse than asking for a realistic timeline upfront.
• Be specific. “We have updated our labeling” is weak. “We have revised the front panel of product SKU 12345 to remove the phrase [specific phrase], effective [date]. See Exhibit A for the revised label” is strong.

What Happens After You Submit Your Response?

The FDA reviews your response and takes one of several paths:

• Matter closed: The FDA determines that your corrective actions adequately address the violations. This is the goal. The matter may not be formally “closed” in writing, but the FDA will not take further action.
• Inadequate response letter: The FDA notifies you that your response was insufficient and may request additional information or a follow-up meeting.
• Regulatory meeting: The FDA requests a meeting — typically called a “regulatory meeting” or “closeout meeting” — to discuss your corrective action plan and timeline in more detail.
• Re-inspection: The FDA schedules a follow-up inspection to verify that corrective actions have been implemented.
• Escalation: In cases where the response is inadequate or the violations are serious, the FDA may escalate to formal enforcement action, including product seizure, injunction, or referral to the Department of Justice.

The outcome depends heavily on the quality of your response, the seriousness of the underlying violations, and your compliance history with the FDA. Companies with a track record of cooperation and good-faith compliance fare significantly better in the enforcement process than those with a history of non-response or repeated violations.

The Biggest Mistakes Companies Make

In our experience representing companies through the FDA warning letter process, these are the mistakes that most often turn a correctable situation into an extended enforcement matter:

1. Ignoring the letter. The FDA does not forget. Non-response is treated as evidence of indifference, and it removes the goodwill that a prompt, substantive response would have generated.
2. Responding without legal counsel. FDA warning letters cite specific legal and regulatory provisions. A response that fails to engage with those provisions — or that inadvertently admits to violations beyond what the FDA alleged — can make a bad situation worse.
3. Making vague commitments. “We will improve our procedures” and “we are working on corrective action” are the two most common phrases that result in inadequate response determinations. Be specific about what, when, and who.
4. Failing to attach documentation. Assertions without evidence are not persuasive to an FDA reviewer who has seen thousands of warning letter responses.
5. Missing the follow-through. If you commit to a corrective action by a specific date, the FDA will check. Missed deadlines after a response has been submitted can trigger re-inspection or escalation even when the initial response was strong.

Do You Need an Attorney to Respond to an FDA Warning Letter?

You are not legally required to have an attorney respond to an FDA warning letter. But in practice, companies that respond without FDA regulatory counsel consistently produce weaker responses — and experience more escalation — than those that work with experienced counsel from the start.

An experienced FDA attorney brings three things to the process that are genuinely difficult to replicate internally:

1. Regulatory knowledge. FDA warning letters cite specific provisions of the FD&C Act, the CFR, and FDA guidance documents. Understanding exactly what is alleged — and where the FDA’s interpretation may be contestable — requires deep familiarity with that regulatory landscape.
2. Response strategy. Knowing what to say is only half the challenge. Knowing what not to say — and how to frame corrective actions in a way that is credible without over-committing — is equally important.
3. Experience with the process. If your response leads to a regulatory meeting, a re-inspection, or follow-up correspondence, having counsel who has been through that process repeatedly is a significant advantage.

Capote Law Firm has been helping dietary supplement, cosmetics, food, and medical device companies respond to FDA warning letters since 2006. If your company has received a warning letter — or if you want to prepare before an FDA inspection — visit our FDA Warning Letter Response page or call (786) 207-1174 to schedule a free consultation.