FDA Requirements for Private Label Products
Which Products Does the FDA Regulate
Not all private label products fall under FDA jurisdiction. The FDA regulates food and beverages (including pet food), dietary supplements (vitamins, minerals, herbs, amino acids), cosmetics and personal care products (skincare, hair care, makeup, deodorant), medical devices (including some wellness products that make health claims), and over-the-counter drugs (products that claim to treat, cure, or prevent disease). The FDA does not regulate general consumer products like home goods, electronics, toys (regulated by CPSC instead), clothing (regulated by FTC), or tools and accessories. If your private label product falls into a non-FDA category, your regulatory obligations are generally limited to FTC labeling requirements and CPSC safety standards where applicable.
The most common mistake private label sellers make is not realizing their product is FDA-regulated. A skincare product marketed as a "face moisturizer" is a cosmetic. The same product marketed as an "anti-aging treatment" is a drug. A herbal tea marketed as a "relaxing beverage" is a food. The same tea marketed as a "sleep aid" is a dietary supplement or drug depending on the specific claims. The marketing claims you make determine which FDA category your product falls into, which directly determines your regulatory obligations. Always research the regulatory implications of your marketing language before creating your listing and packaging.
FDA Requirements for Private Label Food Products
Private label food products are regulated under the Federal Food, Drug, and Cosmetic Act (FFDCA) and the Food Safety Modernization Act (FSMA). The key requirements for private label food brand owners include the following.
Facility registration is required for any facility that manufactures, processes, packs, or holds food for consumption in the United States. Your contract manufacturer must be registered with the FDA, and if you receive, store, or distribute the food products at your own facility before shipping to customers or Amazon, your facility must also be registered. Registration is free and done through the FDA's Unified Registration and Listing System (FURLS) at fda.gov. Foreign facilities must also designate a US agent.
Nutrition Facts labeling is mandatory for most packaged food products. The label must follow the updated 2020 format with specific font sizes, layout requirements, and nutrient disclosure. Small businesses with annual food sales under $500,000 and fewer than 100 employees can apply for a small business exemption, but the exemption process requires documentation and approval. For most private label food brands selling on Amazon, creating a compliant Nutrition Facts panel through laboratory analysis ($300 to $500) or database calculation ($50 to $200) is simpler than applying for the exemption.
Allergen declarations are required under the Food Allergen Labeling and Consumer Protection Act (FALCPA). All major food allergens (milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans, and sesame as of 2023) must be declared on the label either within the ingredient list using the common allergen name or in a separate "Contains" statement immediately after the ingredient list. Failure to declare allergens is one of the most common reasons for food product recalls and can result in serious legal liability if a consumer has an allergic reaction.
FDA Requirements for Private Label Supplements
Dietary supplements are regulated under DSHEA (Dietary Supplement Health and Education Act) with manufacturing requirements defined in 21 CFR Part 111. The regulatory framework is more prescriptive than food but less stringent than pharmaceuticals.
Current Good Manufacturing Practices (cGMP) compliance is mandatory for all dietary supplement manufacturing facilities. cGMP covers identity testing of incoming ingredients, manufacturing process controls, finished product testing for identity, purity, strength, and composition, record keeping for every batch produced, and facility sanitation and equipment maintenance. As a brand owner, you must verify that your manufacturer holds current cGMP certification and maintains compliance through regular audits. Request copies of their most recent FDA inspection report (FDA Form 483) and any third-party GMP audit reports.
Supplement Facts labeling follows specific FDA formatting requirements defined in 21 CFR 101.36. The panel must list every dietary ingredient with the amount per serving and percent daily value (%DV) where established, the serving size and number of servings per container, and all "other ingredients" (inactive ingredients) in descending order of predominance. The label must also include the statement "Dietary Supplement," the manufacturer or distributor's name and address, and the net quantity of contents.
Structure/function claims are allowed on supplement labels and marketing with two conditions: you must have substantiation that the claim is truthful (typically scientific studies supporting the ingredient's benefit), and the label must include the FDA disclaimer: "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease." You must also notify the FDA within 30 days of first marketing a supplement with a structure/function claim by submitting a notification to the Office of Dietary Supplement Programs.
FDA Requirements for Private Label Cosmetics
The cosmetics regulatory landscape changed significantly with the passage of the Modernization of Cosmetics Regulation Act (MoCRA) in December 2022, which added new requirements that phased in through 2024 and 2025.
Facility registration is now mandatory for all cosmetic manufacturing and processing facilities. Both the contract manufacturer's facility and any facility where cosmetic products are processed, packed, or held (including your warehouse if you store products before shipping) must be registered with the FDA through FURLS. This was a major change from the pre-MoCRA era when cosmetic facility registration was voluntary.
Product listing is required for each cosmetic product you sell. The listing must include the product's brand name, product category, list of ingredients, and the responsible person's contact information. Listings must be submitted through the FDA's electronic system and updated annually or when product details change.
Good manufacturing practices are now required by law under MoCRA, though the FDA has not yet finalized specific GMP regulations for cosmetics (as of early 2026, they are using ISO 22716 as a reference standard). Working with manufacturers that already follow ISO 22716 or similar quality standards ensures compliance with both current requirements and whatever final GMP rules the FDA publishes.
Adverse event reporting requires that serious adverse events (death, life-threatening experience, persistent incapacity, hospitalization, birth defect, or the need for medical intervention to prevent any of these) must be reported to the FDA within 15 business days. As the "responsible person" listed on the product label, you are obligated to submit these reports. Maintaining an active customer service channel where customers can report problems is essential for compliance.
Labeling requirements for cosmetics include the product identity, net quantity of contents, ingredients listed in descending order of predominance using INCI nomenclature, the name and address of the manufacturer or distributor, and any required warnings (specific warnings are mandated for products containing certain ingredients like alpha hydroxy acids or coal tar dyes). Color additives used in cosmetics must be FDA-approved for their intended use, and some colors require batch certification.
What Your Manufacturer Handles vs What You Handle
Understanding the split of regulatory responsibility between you and your contract manufacturer prevents gaps in compliance that could result in enforcement action.
Your manufacturer is responsible for: facility-level FDA registration, maintaining cGMP or applicable manufacturing standards, raw material testing and verification, production process controls and batch records, facility sanitation and equipment maintenance, and providing you with Certificates of Analysis (COAs) for finished products.
You as the brand owner are responsible for: product-level FDA registration and listing (supplements and cosmetics), label accuracy and compliance, marketing claim substantiation and compliance, adverse event reporting and customer safety monitoring, ensuring your manufacturer maintains their certifications, and complying with any state-level regulations in states where you sell. The regulatory burden is not eliminated by using a contract manufacturer. It is shared, and the labeling, marketing, and reporting obligations rest squarely on the brand owner.
Staying Compliant Without a Regulatory Attorney
For most private label sellers launching one to three products in a single regulated category, hiring a full-time regulatory attorney is unnecessary if you follow a methodical approach. Work exclusively with FDA-registered, cGMP or ISO-compliant manufacturers who provide regulatory documentation as part of their service. Use the FDA's free online resources (fda.gov/cosmetics, fda.gov/food, fda.gov/dietary-supplements) to understand the specific requirements for your product type. Have your manufacturer's regulatory team review your label design for compliance before printing. Keep records of all COAs, test reports, registration confirmations, and manufacturer certifications.
When you should hire a regulatory consultant or attorney: before launching a product that makes specific health or structure/function claims, if the FDA issues a warning letter or requests documentation, before entering a new regulated category you have not sold in before, and before selling internationally where additional country-specific regulations apply. A regulatory attorney review of your labels and marketing materials costs $500 to $1,500 and provides peace of mind that is worth the investment for brands serious about long-term compliance. Our small business legal guide covers finding and working with attorneys for various business needs.