While the U.S. and China have agreed to reduce tariffs on imported goods, the dietary supplement industry is petitioning the Department of Commerce to exempt nutrients and other dietary ingredients from a Section 232 investigation initiated by the Trump Administration.

This type of investigation is an inquiry to determine whether the imports of certain products present a national security threat, and can entail import controls, tariffs, and other measures. The present Section 232 investigation is intended to determine the national security threat of pharmaceutical imports.

Currently, it appears that the vitamins, amino acids, and other dietary supplement ingredients exempted from the administration’s across-the-board tariffs (the Annex II list) of the April 2 executive order will be subject to the investigation; the inquiry may consider these ingredients to be inputs and derivatives of pharmaceuticals and active pharmaceutical ingredients (APIs), even in cases where they’re intended for other end uses.

Main trade associations including the American Herbal Products Association (AHPA), Consumer Healthcare Products Association (CHPA), Council for Responsible Nutrition (CRN), Natural Products Association (NPA), United Natural Products Alliance (UNPA), and Global Organization for EPA and DHA Omega-3s (GOED), have called for the exemption of dietary supplement ingredients from the investigation, as they are a distinct class of products and raw materials from pharmaceuticals.

In its comments, AHPA focused on the “common and essential dietary ingredients” found in Annex II, as they play a vital role in the formulation of many dietary supplements, and have uses in pharmaceutical, animal feed, conventional food, and personal care product settings. Instead of import controls, AHPA advocated for positive incentives such as direct federal support for domestic production.

“This is all stick and no carrot for commodities that require tremendous infrastructure to be viably produced anywhere,” said Robert Marriott, AHPA director of regulatory affairs. “Positive incentives, not tariffs, are the best and only path to domestic, scaled manufacturing.”

CRN expressed concern that sector-specific tariff structures under Section 232 could lead to severe unintended consequences, such as product shortages, supply chain disruptions, increased costs to consumers, offshoring of U.S. manufacturing jobs, and, specific to dietary supplements, adulteration and the pressure to cut corners.

Further, the Department of Commerce inquiry focuses on pharmaceutical imports’ roles in national security risk, and “the availability of dietary supplements does not create the type of immediate or strategic vulnerability that the investigation seeks to address,” according to CRN. “Tariffs could reduce access to products that enhance Americans’ health and well-being.”

CRN also noted in its comments that many dietary supplement ingredients can’t reliably be produced in the U.S., and urged the department to take a more nuanced approach between ingredients with robust U.S. manufacturing capacity and those that depend on international sourcing.

“Consumers depend on affordable, high-quality supplements to maintain their health, and U.S. manufacturers depend on stable ingredient supply chains to deliver those products,” said Steve Mister, president and CEO of CRN, in a statement. “Tariffs designed to protect national security should not limit access to dietary supplements, thereby endangering American jobs and public health.”

Daniel Fabricant, president and CEO of the Natural Products Association (NPA), requested in an April 28 letter to Secretary of Commerce Howard Lutnick that the Department continue to provide tariff exemptions for ingredients listed in Annex II, and to expand the scope of exemptions to cover “all vitamins, minerals, amino acids, and botanical extracts,” in the case that Section 232 tariffs go into effect. 

Fabricant noted that Americans are “overfed and undernourished,” and that nutrients were designated by the Department of Homeland Security as critical infrastructure during the COVID-19 pandemic. “Over 70% of our industry comprises small businesses, per the Small Business Administration, making it vulnerable to tariff-related cost increases,” he said. “Our reliance on global supply chains for essential ingredients — vitamins, minerals, amino acids, and botanical extracts — stems from their unavailability domestically in sufficient quantity or quality.” 

Further, dietary supplements “play no role in manufacturing or distributing finished drug products, medical countermeasures, active pharmaceutical ingredients, or related derivatives … Excluding our industry from this inquiry aligns with the [Federal Food, Drug, and Cosmetic Act] framework and the Department’s intent to address pharmaceutical supply chain vulnerabilities.”

Loren Israelsen, president and founder of UNPA said in a letter directed to Lutnick: “It is essential for our nation’s health and well-being to maintain a ready and affordable supply of critical nutrients. Over 170 million Americans depend on critical nutrients and other dietary supplements as part of their efforts to improve their nutrition and stay healthy,” including more than 70% of Americans aged 60 and over; women of childbearing age who count on folic acid for healthy pregnancies; parents who count on vitamin D, choline, and other vitamins and minerals in infant formula; and older Americans who rely on calcium, vitamin D, and vitamin B12 supplements to age healthily.

“We submit these comments to bring this dual use for the production of very different products to your attention and to be part of the study record … These ingredients when used in the production of dietary supplements should be excluded from this 232 investigation.”

CHPA, which represents dietary supplements, over-the-counter drugs, and consumer-grade medical devices, expressed similar sentiment. Its comments called for incentives, rather than tariffs, to encourage domestic manufacturing; emphasized the differences between consumer healthcare products and prescription drugs; expressed concerns about out-of-stock shelves, price inflation, and unintended impacts that could lead to substandard products; and more.

“While building greater domestic manufacturing capacity is clearly a shared goal, and we’re pleased to see the Administration recently underscore the need to give industry time to transition, it cannot happen overnight,” said Scott Melville, president and CEO of CHPA. “Our industry depends on a global supply chain for key ingredients and components, and levying tariffs will undoubtedly increase the risk of out-of-stock shelves, price inflation, and counterfeit or substandard products being introduced into the U.S. market. Many of CHPA’s Manufacturer members are investing in expanded U.S. production, but regulatory, infrastructure, and supply chain complexities can take at least 5-7 years. Given the widespread use of these products, and the fact that a significant majority of them are finished in North America, it’s essential that any tariff actions be phased, flexible, proportional, and targeted to clearly defined national security risks rather than a broad application.”

There seems to be no sign that any fatty acids of plant or animal origin, which were included in the Annex II exemption list, will be exempted from the Section 232 investigation, according to GOED.

In its letter, GOED noted that EPA and DHA oils, which were each covered in the Annex, are crucial to maintaining public health, and an exemption for all omega-3 oils is warranted. The organization shared specific tariff codes for ingredients, as provided by member companies. “These fatty acids are crucial to the viability of virtually every cell in the human body and are of vital importance across the lifespan, beginning with prenatal health for reducing the risk of preterm and early preterm birth, and in utero/infant health, particularly brain and eye development, and continuing through to adulthood, where omega-3s support a healthy heart and brain.”