Made in America? What Developers Need to Know About U.S. Supplement Facilities

Arnall Golden Gregory LLP
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Introduction

“Made in America” has strong consumer appeal, but in the dietary supplement industry, reality is far more complex. Roughly 75-80% of raw nutraceutical ingredients (like vitamin C, fish oils, amino acids, and botanical extracts) are sourced internationally, with China being the dominant supplier.1 This dependence isn’t just about cost. Many ingredients, such as botanicals, require specific climates, soil conditions, and multi-year growth cycles that cannot be easily replicated in the U.S.2 Even where domestic cultivation might be possible, it would take years for the plants to reach a harvestable state.3

For developers entering the supplement space, this means new U.S. facilities will still depend heavily on imported ingredients. Site selection must therefore account for global supply chain realities, from port access to regulatory compliance.

Key Factors

Proximity to Major Ports: Facilities will continue importing ingredients, so access to deepwater ports like Savannah, Los Angeles, or Newark is critical. These locations offer faster transit, streamlined customs, and strong rail/interstate connections.

Example: Nexira’s $40 million facility in Augusta, Georgia, illustrates this strategy.4 Nexira produces acacia gum, sourced almost exclusively from Africa. Despite its U.S. location, the facility still relies on imported raw gum. Augusta’s proximity to the Port of Savannah — one of the largest container terminals in North America with direct rail and interstate links — ensures efficient inbound logistics. State incentives likely further strengthened the site’s appeal.

Industrial Zoning and Infrastructure: Sites need reliable energy for climate-controlled storage, wastewater treatment for botanical and chemical residues, and high-capacity roads for logistics.

State and Local Incentives: Competitive states like Georgia, Nevada, North Carolina, Texas, and South Carolina offer tax abatements, training grants, and other incentives for job-creating industrial developments.5

FDA Compliance and Lease Considerations: FDA compliance is non-negotiable. Facilities must comply with FDA’s current Good Manufacturing Practices (“cGMP”) under 21 CFR Part 111, which govern everything from ingredient sourcing to recordkeeping and quality control.6 FDA conducts both routine and for-cause inspections, often without prior notice, to verify ongoing compliance.7 If you are leasing a manufacturing plant for a dietary supplement company, the lease language should clearly shift the compliance burden to the tenant. Key considerations include:

  • Tenant Responsibilities
    • Full Regulatory Compliance: Tenant is solely responsible for complying with all federal, state, and local laws and regulations, including FDA cGMP requirements.
    • Facility Operations: Tenant ensures facility layout, equipment, sanitation systems, and processes meet cGMP standards.
    • Inspection Cooperation: Tenant must allow FDA or other regulatory inspections and promptly correct violations.
    • Third-Party Certification: Consider requiring the tenant to obtain and maintain certification from an accredited third-party program.8 Because FDA inspections are infrequent and random, ongoing third-party audits help ensure compliance with cGMP requirements and identify issues before they become regulatory problems.
  • Lease Protections for Landlord
    • Indemnification: The tenant indemnifies landlord against claims or penalties arising from non-compliance.
    • Access Rights: The landlord retains the right to access the property to verify compliance with lease provisions, but not to manage or supervise operations.

Looking Forward

The dietary supplement sector offers real estate opportunities, but global supply chains, tariff volatility, and strict FDA oversight add complexity. Developers and landlords succeed by prioritizing strategic site selection, port access, zoning alignment, and regulatory readiness — supporting U.S. supplement manufacturing without ignoring global sourcing realities.

[1] Adrien, Claudia. “Dietary Supplement Industry Considers the Future of U.S.-China Tariffs.” NutraIngredients-USA, 5 Nov. 2024, https://www.nutraingredients-usa.com/Article/2024/11/05/Dietary-supplement-industry-considers-the-future-of-U.S.-China-tariffs/; see also Hoffman, Ronald. “New Tariffs Pose Unprecedented Challenges for Supplements.” Dr. Ronald Hoffman, 11 Apr. 2025, https://drhoffman.com/article/new-tariffs-pose-unprecedented-challenges-for-supplements/.

[2] See Hoffman, Ronald. “New Tariffs Pose Unprecedented Challenges for Supplements.” Dr. Ronald Hoffman, 11 Apr. 2025, https://drhoffman.com/article/new-tariffs-pose-unprecedented-challenges-for-supplements/; see also U.S. Environmental Protection Agency. Climate Change Impacts on Agriculture and Food Supply. U.S. Environmental Protection Agency, 11 Aug. 2025, https://www.epa.gov/climateimpacts/climate-change-impacts-agriculture-and-food-supply; see also Montemarano, Mike. “Botanical Supplies Feel the Effects of Climate Change.” Nutraceuticals World, 21 Aug. 2022, https://www.nutraceuticalsworld.com/exclusives/botanical-supplies-feel-the-effects-of-climate-change/; French, Rachel. “China-Sourced Botanicals ‘Most Severely Impacted’ by Tariff Hikes.” SupplySide Supplement Journal, 17 Apr. 2025, https://www.supplysidesj.com/market-trends-analysis/china-sourced-botanicals-most-severely-impacted-by-tariff-hikes

[3] French, Rachel. “China-Sourced Botanicals ‘Most Severely Impacted’ by Tariff Hikes.” SupplySide Supplement Journal, 17 Apr. 2025, https://www.supplysidesj.com/market-trends-analysis/china-sourced-botanicals-most-severely-impacted-by-tariff-hikes

[4] “Augusta’s Economic Development in 2024 Likely Will Set Up Strong 2025.” The Augusta Chronicle, 8 Jan. 2025, https://www.augustachronicle.com/story/business/economy/2025/01/08/augustas-economic-development-in-2024-likely-will-set-up-strong-2025/77519554007/

[5] Competitive states like Georgia, Nevada, North Carolina, Texas, and South Carolina offer tax abatements, training grants, and other incentives for job-creating industrial developments; Governor’s Office of Economic Development. “Incentives.” Nevada Governor’s Office of Economic Development, 2025, https://goed.nv.gov/incentives/; Council for Community and Economic Research. State Business Incentives Database. Council for Community and Economic Research, 2025, www.stateincentives.org

[6] U.S. Food and Drug Administration. Dietary Supplements Guidance Documents & Regulatory Information. U.S. Food and Drug Administration, 2024, https://www.fda.gov/food/guidance-documents-regulatory-information-topic-food-and-dietary-supplements/dietary-supplements-guidance-documents-regulatory-information

[7] Long, Josh. “FDA Increases Annual Domestic, Foreign Dietary Supplement Inspections.” SupplySide Supplement Journal, 13 Dec. 2024, https://www.supplysidesj.com/supplement-regulations/fda-increases-annual-domestic-foreign-dietary-supplement-inspections; Parshad, Andrew. “How to Master FDA Audits for Your Dietary Supplement Facility: A Complete Preparation Guide.” Quality Smart Solutions, 13 Nov. 2024, https://qualitysmartsolutions.com/blog/how-to-master-fda-audits-for-your-dietary-supplement-facility-a-complete-preparation-guide/

[8] Long, Josh. “FDA cGMP Inspections: Filling in the Gaps with Accredited Third-Party Program.” SupplySide Supplement Journal, 23 May 2025, www.supplysidesj.com/supplement-regulations/fda-cgmp-inspections-filling-in-the-gaps-with-accredited-third-party-program

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations. Attorney Advertising.

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