Selling Collagen and Protein Powder in the U.S.: FDA, Labeling, and Amazon Guidelines

Sales of collagen and protein powder to the U.S. have been one of the most notable export sectors for Turkish manufacturers in the U.S. sports nutrition and dietary supplement market in recent years. Protein powder, meal replacement, and collagen products are seeing strong and steady demand both in retail and on Amazon. Turkey’s dairy and meat processing infrastructure, along with its contract manufacturing capacity, also offers a significant cost and quality advantage in this category.

However, this product group has a more complex structure than ordinary food products when it comes to entry into the U.S. There are two distinct reasons for this: first, the fact that the majority of these products fall under the “dietary supplement” category; second, the inclusion of animal-derived ingredients, such as collagen, which can raise concerns not only with the FDA but also with the USDA. If these two aspects are not properly addressed, delays in shipping and listing may occur, regardless of the product’s quality.

In this guide, we take a step-by-step look at the process of entering the U.S. market with collagen and protein powder products, using the projects we’ve advised on as examples.

Why Is the U.S. Nutritional Supplement Market So Attractive?

The U.S. is the world’s leading market in terms of per capita spending on dietary supplements. The positioning of collagen as a beauty and joint health product, and protein powder as a performance and daily nutrition product, are driving growth in their respective segments. The meal replacement category also continues to expand as practical eating habits become more widespread.

Amazon accounts for a significant portion of this demand. With the right labeling, the right claim structure, and the right launch strategy, it is possible for a product manufactured in Turkey to find its way onto store shelves in the U.S. The key is to ensure that the regulatory requirements are in place before the product is launched.

Two Things That Set Collagen and Protein Powder Apart from Other Foods

Dietary Supplement Category

In the U.S., if a product’s label includes the term “dietary supplement,” the product is subject to a different regulatory framework than conventional foods. A “Supplement Facts” panel is required instead of a “Nutrition Facts” panel, the ingredient list is formatted differently, and the claims made on the product undergo a separate evaluation.

For some products, omitting this statement from the label altogether may make more sense because it allows the product to be marketed as a lighter option. This decision depends on the formulation, the target segment, and the claims made; therefore, it’s a decision that must be made before the label design is finalized.

Animal-Derived Ingredients

Collagen peptides can be derived from beef or fish. Protein powders, on the other hand, contain dairy derivatives such as whey and casein, as well as egg derivatives in some formulations. These animal-derived ingredients may require approval not only from the FDA but also from the USDA for import into the U.S. This is the most critical difference that distinguishes this category from plant-based supplements.

Step 1: U.S. Company and Tax ID Number (LLC + EIN)

The foundation for becoming a professional seller on Amazon in the U.S. and operating as an importer is having a U.S. legal entity and an EIN. Technically, it is possible to sell without a U.S. company; however, the LLC + EIN structure significantly simplifies the process in terms of bank accounts, trademark applications, customs registration, and payment collection.

Step 2: FDA Food Facility Registration, U.S. Agent, and DUNS

The facility in Turkey that manufactures the product must be registered with the FDA and must appoint a U.S. Agent. The registration is renewed every two years. A DUNS number is also obtained to identify the facility.

Prior to each shipment, an electronic prior notice must be submitted to the FDA and customs, and the U.S. importer must have an FSVP plan in place that verifies the supplier’s compliance. These three requirements form the gateway for the product’s entry into the U.S.

For practical steps regarding the FDA: Our FDA Registration and Certification Guide · FDA Labeling and Customs Advisory Guide

Step 3: Label and Formulation Compliance Review

In this category, the label is the most critical element of the process. The audit is conducted by product group and covers the following topics:

• Evaluation of the formulation under FDA guidelines to determine whether the ingredients have approved additive, GRAS, or acceptable status
• Compliance of the Nutrition Facts panel with the U.S. format, serving size and daily value calculations
• Ingredients list and allergen declaration (major allergens such as milk, eggs, soy, and fish)
• Analysis of structure-function claims, i.e., which statements can be used on the product
• Mandatory label elements such as net quantity, manufacturer/distributor information, lot number, and expiration date

The entire label must be in English. Statements claiming that the product treats or prevents a disease are not permitted; such claims can lead to issues with both regulatory authorities and Amazon.

Required elements on the U.S. label (file: supplement-facts-label-elements.webp · alt text: Required elements that must appear on the U.S. Supplement Facts label)

Step 4: Animal-Derived Ingredients and USDA APHIS VS Authorization

This heading highlights what sets collagen and milk-based protein products apart from other supplements in this category. For products containing ingredients of animal origin, an import permit from the USDA APHIS Veterinary Service (VS) may be required to prevent the introduction of foreign animal diseases.

Whether authorization is required depends on the source of the animal-derived ingredient in the formulation, the degree of processing, and the country of origin. For this reason, identifying the ingredients during the formulation review is important for proper planning of the process. In some cases, a health certificate may be required from the country of origin.

The practical approach is as follows: During label and formulation reviews, the animal-derived content is clarified, and then it is determined whether USDA approval is required. This sequence helps prevent any surprises during the shipping phase.

Step 5: Customs Registration and Customs Bond

ABD’ye ticari sevkiyat yapabilmek için ithalatçı kaydının kurulması ve yıllık customs bond düzenlenmesi gerekiyor. Bu iki kalem, sevkiyatların gümrükten sağlıklı geçişinin operasyonel altyapısını oluşturuyor ve genelde ilk sevkiyat planlanmaya başladığında devreye alınıyor.

Step 6: Amazon Gated Category Approval and Launch

Dietary supplements are a "gated" category on Amazon U.S. It is not possible to send these products to FBA fulfillment centers or list them without approval. The following are typically required for the approval application:

• Invoices dated within the last 180 days, issued by an authorized supplier, and showing the purchase of a specific quantity of products
• Product photos that clearly show all sides of the packaging and required fields such as the Nutrition Facts panel
• FDA Compliance Documents by Product Type
• In some cases, a certificate of analysis (COA)

Once approval is received, preparations for the listing, A+ content creation, Storefront setup, FBA shipping planning, and PPC setup begin. Reaching the initial social proof phase of the launch is considered the point at which the setup process is complete.

For Amazon: Dietary Supplement Sales in the U.S. and the FDA Compliance Process · Amazon Private Label Getting Started Guide

Two-Component Work Model

In this category, handling the regulatory and sales aspects separately is often not efficient. A decision made regarding the label directly affects the Amazon listing, while the positioning established in the listing directly affects the claim structure on the label. For this reason, it may make more sense to manage the process within a single, two-part framework.

The most significant advantage of this model becomes apparent when it is implemented while products are still in the design phase. Decisions regarding packaging, labeling, and content can be planned collaboratively from the very beginning to align with an Amazon launch, thereby reducing the need for revisions later on.

Roadmap Summary

This company aims to establish its regulatory framework before the product launch. In a highly regulated category such as dietary supplements, proper compliance significantly reduces risks on both the customs and Amazon account sides.

Frequently Asked Questions

Does a collagen product require FDA approval?

The FDA does not approve dietary supplements on a case-by-case basis. However, certain requirements—such as facility registration, appointment of a U.S. Agent, prior notice, FSVP, and label compliance—are mandatory. Amazon also requires these documents as part of its own approval process.

Do I have to include the phrase “dietary supplement” on the label?

It is not mandatory. Depending on the product’s positioning and formulation, omitting this statement may allow the product to remain under a less stringent compliance regime. The decision is made during the formulation review.

Is USDA approval required for collagen in all cases?

No. The requirement varies depending on the source of the animal-derived ingredient and the degree of processing. For this reason, the determination of the content is made during the formulation review and finalized based on the results.

My product is still in the design phase—does it make sense to start the process now?

This is generally the most efficient approach. Conducting a compliance review before the packaging and labels are printed eliminates the cost of revisions later on and ensures that content decisions are structured to align with the Amazon launch.

Can my label be in Turkish?

No. According to both FDA and Amazon regulations, the label must be in English and include all required elements.

Conclusion

Entering the U.S. market with collagen, protein powder, and meal replacement products presents a significant opportunity for Turkish manufacturers. However, success depends first and foremost on navigating the regulatory framework—including LLC and EIN registration, FDA facility registration, label and formulation reviews, evaluation of animal-derived ingredients, customs infrastructure, and Amazon approval—before even considering product quality.

Completing these steps in the correct order reduces risks on both the customs and Amazon sides and makes the launch more predictable.

If you’re planning to enter the U.S. market with a dietary supplement or any other food product, we at Export Partners are here to support you every step of the way through the FDA registration and certification processes, the sale of dietary supplements in the U.S., and the trademark registration process in the U.S.

Other guides in this series

This guide is part of a series explaining FDA processes for exporting to the U.S. Other related guides:

• How the Export of Supplements to the United States Works
• Sales of dietary supplements in the United States
• FDA registration, DUNS number, and labeling for beverage exports to the U.S.
• For support with registration and certification, please see our FDA registration and certification services.