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Low MOQ Capsule Manufacturing - Explore our cGMP-compliant, formulator-grade custom capsule manufacturing solutions. Specializing in advanced botanical extracts, targeted nutrients, and fully compliant private label packaging designed for premium global brands.

Essential FDA Requirements for Dietary Supplement Labeling: A Comprehensive Compliance Guide

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Essential FDA Requirements for Dietary Supplement Labeling: A Comprehensive Compliance Guide No. 1picture


1. Statement of Identity

The product must be clearly identified by its common or usual name. Unlike "drugs," these products must explicitly feature the term "dietary supplement" on the Principal Display Panel (PDP). You may replace "dietary" with the type of ingredient, such as "Herbal Supplement" or "Calcium Supplement."

2. Net Quantity of Contents

This statement informs the consumer of the total amount of product available in the package. It must be placed in the bottom 30% of the PDP and expressed in:

  • Weight, measure, or numerical count (e.g., 60 Veggie Capsules or Net Wt. 500mg).

3. The Supplement Facts Panel (Nutrition Labeling)

This is the technical core of the label. It must be enclosed in a box and include:

  • Serving Size & Servings Per Container: Standardized based on the recommended consumption.

  • Mandatory Nutrients: Total calories, fat, sodium, carbohydrates, etc., if present in significant amounts.

  • Dietary Ingredients: Quantitative amounts of vitamins, minerals, or botanicals.

  • Percent Daily Value (% DV): Based on the 2,000 calorie reference diet where applicable.

4. Ingredient List (Excipients and Allergens)

Ingredients not listed in the "Supplement Facts" panel must be listed below it as "Other Ingredients."

  • Order of Predominance: Ingredients must be listed in descending order of weight.

  • Allergen Disclosure: Under the FALCPA, major allergens (e.g., soy, milk, wheat) must be clearly identified.

5. Name and Place of Business

The label must provide the physical address of the manufacturer, packer, or distributor. For independent brands, this often includes a domestic US address or a phone number to facilitate Adverse Event Reporting (AER).


The Mandatory FDA Disclaimer

If your label features a Structure/Function claim (e.g., "Supports Immune Health"), the FDA strictly requires the following disclaimer to be displayed in a bold box:

"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."


Technical Formatting Checklist

  • Font Size: Generally, the "o" in the smallest text must be at least 1/16th of an inch.

  • Prominence: Information must be "likely to be read and understood by the ordinary individual under customary conditions of purchase."

  • Language: All mandatory information must be in English.

Ready to Manufacture Your Premium Private Label Line?

At www.oemsupplementmaker.com, low moq supplement manufacturer, we transform cutting-edge metabolic science into premium, retail-ready supplements. Manufacturing high-quality formulas under strict ISO 22000 global Food Safety standards requires a strictly controlled manufacturing environment maintained strictly below 20% relative humidity and 14°C. These advanced measures stop moisture absorption, protect low-melting active ingredients from breaking down, and guarantee perfect dosage uniformity across every capsule without the risk of batch separation or machinery jams.

With our accessible low-MOQ manufacturing tracks (starting at just 500 to 1,000 bottles), your brand can confidently launch a premium, doctor-formulated product line utilizing ISO 22000 certified manufacturing without locking up massive upfront capital or risking slow-moving inventory. From raw material identity testing and High-Performance Liquid Chromatography (HPLC) potency verification to fully compliant label documentation, we handle your entire custom manufacturing process with absolute precision.

We specialize in the US dietary supplement market, serving as the premier contract manufacturer for gyms, community brands, and wellness startups across the nation. We break down traditional industry barriers by offering fully custom capsule formulations in small batches (Low MOQ) paired with reliable Door-to-Door Delivery.

From coast to coast, we provide seamless fulfillment to growing brands across the continental US, with a strong logistics network serving client hubs in California, New York, Texas, Ohio, Utah, Washington, and beyond.

❓ Frequently Asked Questions (FAQ)

Q1: What is your Minimum Order Quantity (MOQ) for custom capsule supplements?

A: We offer some of the most flexible low MOQs in the US market, starting as low as 500 to 1,000 bottles depending on your Custom Formulation. We intentionally break down the traditional industry barrier of 5,000+ bottles to help gyms, local wellness brands, and startups launch test batches with minimal upfront capital and zero inventory risk.

👉 [Contact our team today to get an instant MOQ quote for your custom capsule formula!]

Q2: Do you offer fully custom capsule formulations, or only pre-made stock formulas?

A: We specialize in 100% fully custom capsule formulations tailored specifically to your brand’s needs—whether it’s for weight management, prostate support, mood elevation, or vascular health.

👉 [Have a Custom Formula idea? Send us your ingredient list for a free technical evaluation!]

Q3: How does your door-to-door delivery service work across the United States?

A: We provide hassle-free, door-to-door delivery directly to your facility, gym, or warehouse anywhere in the continental US. Through our robust national logistics network, we regularly serve client hubs in California, New York, Texas, Ohio, Utah, Washington, and beyond. We handle all Shipping logistics, tracking, and inland transport so you can Focus entirely on marketing and sales.

👉 [Request a shipping estimate to your state today!]

Q4: Are your manufacturing facilities compliant with US FDA and cGMP standards?

A: Absolutely. All products manufactured through www.oemsupplementmaker.com are produced in FDA-registered and cGMP-certified facilities. We adhere to rigorous quality control protocols, including identity, purity, and heavy metal testing, ensuring your Custom Capsules meet all federal regulations and pass third-party lab testing (Label Claim Assays) with total transparency.

👉 [Ask us for sample COAs and compliance verification for your next batch!]

Q5: What is the typical lead time from formula approval to door-to-door delivery?

A: For most custom capsule orders, our standard production and delivery timeline is 4 to 6 weeks after final formula and label artwork approval. If you are ordering sample custom formulations, pilot samples can be prepared in as fast as 7 to 10 business days. We prioritize fast turnaround times to keep your startup agile and fully stocked.

👉 [Start your custom formulation process today to lock in your production timeline!]

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