Introduction: Timing Your Entry into the US NMN Supplement Market
With the FDA’s official approval of NMN as a dietary supplement ingredient in September 2025, the U.S. NMN supplement market has entered a new phase of growth. E-commerce sales of supplements have increased by 49%, and the NMN market has expanded to account for approximately 61% of the total market in North America alone.
However, entering the US market requires preparations different from those in Japan, such as regulatory compliance, quality standards, and labeling requirements. This article explains the process of starting sales of NMN supplements in the US in eight chronological steps.
Overall Schedule Overview (Estimated Timeline Until Sales Start)
The estimated schedule, calculated backward from the sales start date (Day 0), is as follows:
6-5 months prior: Business concept development, target setting. 5-4 months prior: Formulation design, ingredient sourcing. 4-3 months prior: OEM partner selection, trial production/mass production. 3-2 months prior: Quality testing, safety data preparation. 75+ days before sale: NDI notification (NDIN) submission. 2-1 month prior: Label and packaging creation. 1 month prior to launch: Export procedures, customs preparation. Day 0: Sales start.
Manufacturing can be done in as little as one month for small lots, but since NDIN submission to review completion takes at least 75 days, it is realistic to expect a total of about 5 to 6 months.
STEP 1 — Business Concept and Target Setting (6-5 Months Prior)
Motivations for NMN Purchase and Price Ranges Among US Consumers
According to a survey, Baby Boomers and Generation X account for 78% of NMN supplement buyers in the United States. The primary motivations for purchase are "extending healthy life expectancy" and "anti-aging care at the cellular level," and the typical price range for a one-month supply (30 days) is $40 to $120.
In the premium price range ($80+), quality claims such as "high purity," "third-party tested," and "Made in Japan" strongly influence purchase decisions.
Brand Positioning Determination
Before entering the market, you should clarify three points: price range (entry-level/mid-range/premium), main sales channels (Amazon/own e-commerce/wholesale), and differentiation axes (purity/formulation/country of manufacture/additional ingredients). Deciding on the direction at this stage will make subsequent steps proceed smoothly.
STEP 2 — Prescription Design and Raw Material Procurement (5-4 months prior)
Determination of NMN Content (Market Standards and Differentiation)
The standard daily dosage for NMN supplements sold in the US market is 250mg to 500mg. High-dose products of 1,000mg or more are positioned in the premium segment.
The determination of the dosage is based on a comprehensive consideration of its alignment with the target price range, the dosage used in clinical studies (250-900mg/day in many studies), and differentiation from competing products.
Raw Material Selection Criteria: Yeast Fermentation Method vs. Chemical Synthesis Method
The manufacturing methods for NMN raw materials are broadly divided into yeast fermentation and chemical synthesis. Since the yeast fermentation method is produced through a natural process, it has the advantage of being easy to promote as "natural" and readily accepted by consumers with a clean label orientation in the United States.
When selecting raw materials, you should verify that they are β-NMN (β-form), have a purity of 99.1% or higher, come with a Certificate of Analysis (CoA) for heavy metals and microorganisms, and demonstrate consistent quality across batches.
STEP 3 — OEM Partner Selection and Manufacturing (4-3 months prior)
Five points to check when selecting
Here are five checkpoints to consider when choosing an OEM partner:
Whether GMP certification is obtained, and the scope of certification. Manufacturing track record for products destined for the US. Whether small-lot production is possible and the minimum order quantity (MOQ). Support system for NDI notification and US label creation. Lead time (from prototyping to mass production).
Small batch prototyping and mass production flow
The general process is: Prescription confirmation -> Prototype manufacturing -> Quality check -> Prescription fine-tuning -> Mass production. From prototyping to mass production, it takes about 1 to 1.5 months in the fast case.
STEP 4 — Quality Testing and Safety Data Preparation (3-2 months prior)
Essential quality test items
Quality tests that should be conducted for NMN supplements for the US market include content testing (confirmation of NMN content), purity testing, heavy metal testing (lead, arsenic, mercury, cadmium), microbial testing (coliforms, Salmonella, yeast, mold, etc.), and disintegration testing.
These test results will be compiled into a Certificate of Analysis (CoA) for the product. Obtaining certification from third-party organizations (such as NSF, USP, Informed Sport, etc.) will significantly improve credibility when developing sales channels.
NDI Notification Safety Data Preparation
Safety data required for NDIN submission includes chemical identification information of the ingredients, toxicity and clinical trial data demonstrating safety at recommended doses, and a review of existing scientific literature. Whether OEM partners can obtain safety data packages from raw material manufacturers is an important selection criterion.
STEP 5 — Submit Notice of Proposed Importation (NDI) (At least 75 days before sale)
NMN is categorized as a New Dietary Ingredient (NDI), so an NDIN submission to the FDA is required. The submission must be made at least 75 days before the product's sale begins.
If the FDA does not object after the submission, a "good day letter" will be issued. It is crucial to ensure this procedure is followed, as omitting it carries the risk of facing FDA enforcement action.
It is recommended to utilize a Regulatory Affairs Consultant for the creation of an NDIN. The cost will depend on the complexity of the project, but the general range is from several thousand to tens of thousands of dollars.
STEP 6 – Create US Labels & Packaging (2-1 month prior)
Supplement Facts Panel Labeling Requirements
米国でサプリメントを販売するには、FDA規定のSupplement Factsパネルをラベルに記載する必要があります。記載すべき項目は、サービングサイズ、サービングあたりの成分量、%Daily Value（設定されている成分の場合）、その他の成分（Other Ingredients）です。
Since a Daily Value has not been established for NMN, it will be listed with a "†" mark and "Daily Value not established."
Points to note regarding Structure/Function claims
In the United States, expressions that imply the treatment or prevention of diseases are prohibited on dietary supplement labels. Only Structure/Function claims are permitted.
For example, "Supports the maintenance of NAD+ levels" is acceptable, but "Treats aging" or "Prevents diabetes" is not allowed. If using a claim, notification to the FDA (within 30 days of issuing the claim) and the disclaimer "This statement has not been evaluated by the FDA..." are required.
STEP 7 - Export Procedures and Customs Clearance Preparation (1 Month Prior ~)
List of required documents
The main documents required when exporting supplements from Japan to the United States are as follows: Commercial Invoice, Packing List, Certificate of Analysis (CoA), Certificate of Origin, FDA Facility Registration Number, and Prior Notice (to be submitted 15 days prior to arrival to before arrival).
FSVP (Foreign Supplier Verification Program) Compliance
FSVP is a program that requires U.S. importers to verify that products from foreign suppliers meet U.S. safety standards. While the Importer of Record in the U.S. is responsible for FSVP compliance, Japanese manufacturers are also required to prepare for the following.
Proof of GMP compliance for manufacturing facilities. Documentation of quality control systems. Sharing of hazard analysis results. Readiness to accept regular audits.
Whether your U.S. partner (importer of record or distributor) is familiar with FSVP compliance is also an important criterion for selecting a partner.
STEP 8 — Channel Development and Sales Launch
Practical Use of Amazon.com
Amazon.com is a major sales channel for NMN supplements. When listing products, please review Amazon's listing requirements for the supplements category (product images, Supplement Facts images, submission of CoA, etc.). If you plan to use Fulfillment by Amazon (FBA), you will also need to arrange for delivery to a fulfillment center within the US.
Shopify Self-Built E-commerce Launch
Your own e-commerce site is effective for conveying your brand's story and acquiring repeat customers. Shopify is widely used for selling supplements in the U.S. and makes it easy to incorporate subscription features.
Via wholesaler/distributor
Wholesale distribution to clinics, wellness shops, and specialty retailers contributes to building brand credibility. When dealing with distributors in the US, it is necessary to negotiate terms such as exclusivity/non-exclusivity, minimum order quantities, and margin structures in advance.
Common failure patterns and how to avoid them
Failure Pattern 1: Starting sales without submitting the NDIN. As a workaround, incorporate an NDIN submission schedule retroactively before starting manufacturing.
Failure Pattern 2: Not knowing US labeling regulations and shipping with Japanese labels. As a workaround, it is recommended to hire a designer or consultant familiar with US regulations for label creation.
Failure Pattern 3: Exporting without securing an Importer of Record. As a countermeasure, secure the U.S. Importer of Record in the early stages of your business plan.
Failure Pattern 4: Pricing is solely based on cost-plus, with no consideration for market prices. As a workaround, conduct competitor research first, then design costs backwards from the selling price.
Regarding the legal background of FDA regulations and the details of the NDIN process[Detailed Legal Version] Legal Background of US NMN Regulation and Practical Guide to NDINPlease look.
Regarding export operations (customs clearance, FSVP, English labeling)US Export Practice Guide for Japanese-Made NMN Supplementsis explained in detail.
Regarding regulations for advertising in the United StatesNMN Supplement Advertising: US Labeling Regulations GuidePlease also refer to.
Summary
To sell an NMN supplement in the US market, there are many steps from formulation design to NDI notification, label creation, export procedures, and sales channel development. Expect an overall lead time of 5 to 6 months, and it's particularly important to incorporate the 75-day rule for NDI notification into your schedule.
By leveraging high-quality NMN ingredients and GMP-certified factories within Japan, and by capitalizing on the reliability of "Made in Japan," it is possible to establish a differentiated position in the US market.
If you are considering OEM manufacturing of NMN supplements, including market entry into the United States, we offer one-stop consultation services from formulation design to export procedures. Please feel free to contact us. Inquiries to our company can be made here: https://b-nmn.jp/contact
FDA NDIN Guidance (2024), FSVP 21 CFR Part 1 Subpart L, DSHEA Section 8, Amazon Seller Central Guidelines, NutraIngredients-USA Market Data
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