The Essential Guide To Importing Dietary Supplements

Overcoming the unique challenges of importing dietary supplements to the United States can seem daunting. If you plan to import such a commodity, you need to be aware of the products, market trends, and regulations involved in the process.

Key Takeaways:

• Dietary supplements fall under various HS codes, with the most common being 3004 for vitamins, 2936 for provitamins, and 0910 for spices. 
• In 2023, Vitamin D, Magnesium, and Fish Oil were among the top supplements imported into the U.S.
• The top countries exporting to the U.S. include China, Canada, Switzerland, India, and Germany.
• Importers must ensure compliance with FDA labeling requirements, including supplement facts, country of origin, and ingredients.
• Dietary supplements must meet FDA guidelines, including proper labeling, GMP standards, and adherence to the FSVP.

Our guide below provides importers with everything they need to know about importing dietary supplements into the U.S.

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Qualifying Imports: HS Codes for Dietary Supplements

Supplements can be derived from a wide variety of natural sources and be manufactured in diverse forms including pills, teas, gummies, and more. 

As such, Harmonized Schedule (HS) classifications for these goods are spread out across multiple chapters. I’ve included some of the most common four-digit HS codes for dietary supplements in the table below. 

To get an idea of which supplements are most commonly sold in the U.S., we’ll need to drill down a little further into some more specific examples. 

What are The Most Popular Supplements To Import?

Knowing which supplements are in greatest demand is one of the first steps you should take before you begin importing them. The next step is finding a supplier.

Which Countries Export Dietary Supplements to the US?

While several countries export dietary supplements, importers in the United States sourced these goods from the following countries most often in 2023:

• China
• Switzerland
• Canada
• India
• Germany

Out of these five countries, Canada arguably offers the best value to U.S. importers due to its proximity and the country’s participation in the United States-Mexico-Canada Agreement (USMCA). However, China still stands tall as an option due to low commodity prices, high availability, and capacity for production.

Given their perceived (and still somewhat accurate) status as a top exporter of goods to the U.S., it’s worth examining the current state of trade relations with China country before deciding to source goods from them.

Do Section 301 Tariffs Apply to Dietary Supplements?

Section 301 tariffs are specifically levied against many products sourced from China. This is due to the U.S. government’s determination that many businesses in China receive subsidies from their own government to fund manufacturing operations, which reduces their costs to the point that U.S. manufacturers can’t realistically compete. 

While these tariffs do impact many Chinese goods, supplements classified under the aforementioned 3004 and 2936 HS codes are not affected as of September 2024, while those under 0910 are subject to an additional 10% duty. 

Importers should always check for increased or newly implemented tariffs when importing from China due to the currently volatile trade relationship between the two countries.

Regardless of your choice, your supplier’s goods will need to comply with regulations set by the FDA.

Related: A Guide to China’s Section 301 Tariffs

Does the FDA Need to Approve Dietary Supplements?

The FDA doesn’t pre-approve every shipment of dietary supplements that enters the U.S. Instead, the organization establishes and enforces regulations that all manufacturers, importers, and distributors must follow. 

The responsibility for meeting FDA guidelines rests with the company that introduces a product to market. When products meet those standards, it may be acceptable to say they have FDA approval. 

Companies must ensure that the available information is correct and not misleading. The rules enforced combat fraud, false advertising, and mislabeling. 

Do I Need a Permit to Import Dietary Supplements?

In much the same way they don’t approve shipments, the FDA doesn’t issue permits either, though there is a registration process for importers and manufacturing facilities. 

There is a caveat here that importers should be aware of. If you’re importing raw materials from plants and/or animals to manufacture supplements in the USA, you may need a permit from the USDA’s Animal and Plant Health Inspection Service (APHIS). Otherwise, as long as the supplements have met FDA standards, you’re good to go.  

Related: The Complete Guide to FDA Customs Clearance

Requirements for Importing Dietary Supplements

The FDA has specific regulatory requirements for importers of drugs, including dietary supplements. These exist in conjunction with more generalized rules that apply to all imported goods. 

Let’s take a closer look at some of these requirements.

Proper Import Documentation: 

Several documents need to accompany shipments entering the United States, including the following:

• Packing list
• Bill of lading (BoL)
• Commercial invoice
• CBP Entry Summary 7501
• Certification of Origin (when claiming preferential duty rates from an agreement such as the USMCA)

Learn more about general import documents in our article, “What Documents Do I Need to Import and Export?”.

Good Manufacturing Practice (GMP) Standards

These standards are in place to ensure foreign suppliers align their manufacturing practices with those that American manufacturers must follow. GMP acts as further insurance against substandard and potentially dangerous products entering the country.

These practices are laid out in title 21, subchapter B, part 111 of the Federal Code of Regulations. It’s an exhaustive list, but the key takeaways are listed below.

• Preventing Microbial Contamination: Personnel who are ill or suspect they have a health condition that could expose products to harmful microbes must disclose this condition to their supervisors. The affected employee should be kept away from operations until the risk of contamination has passed.
• Ensuring Proper Hygiene: Employees must remove jewelry, wash and sanitize their hands as necessary. Proper protective garments must also be worn.
• Qualifying Supervisors: These higher-ranking individuals must be experienced and given additional training & education as required.
• Standards for Plant Care and Grounds Sanitation: Equipment must be stored properly, waste must be removed and disposed of properly, and the plant itself requires a safe water supply. Pest control is also a crucial aspect of this requirement.
• Record Keeping: These include general record keeping, pest control records, and data showing that water that may become part of a dietary supplement meets federal quality standards. 
• Writing Procedure Requirements: Facilities must have written instructions for calibrating instruments, maintaining equipments, and cleaning. 

GMP is a cornerstone of the FDA verification program for businesses that export food and pharmaceuticals to the USA. 

Foreign Supplier Verification Program (FSVP)

The FSVP’s goal is to establish accountability for foreign suppliers. Essential requirements include:

1. The burden of safety compliance rests on the importer and the foreign supplier.
2. If no employees are in the U.S., the importer will need an agent to carry out the FSVP responsibilities.
3. Agreements with agents must be in writing.
4. The agent must be identified in the U.S. customs paperwork submitted with each imported shipment.
5. An adequate plan must be put in place by the agent or importer to verify that FDA standards are in place.
6. Importers have varying flexibility in meeting requirements. However, food must not be misrepresented  or altered in any way.

Imported dietary supplements are subject to FDA inspection when arriving at any port of entry. The FDA may hold or seize shipments that do not comply with U.S. regulations, such as those that establish labeling requirements. We’ll go over FSVP specific labeling needs in the next sections. 

Labeling Requirements

The FDA has strict requirements for medicines of all kinds. The label format should include the following: 

1. Statement of Identity: The food’s name properly displayed on the principal display panel (PDP) of the label.
2. Supplement Facts: Separate from the nutritional facts, this list includes the source of the ingredients, including the part of the plant where the ingredient comes from.
3. Country of Origin: This is mandatory for all consumer products sold in the U.S.
4. Ingredients List: A detailed listing of all ingredients used to make the product.
5. Total Net Quantity: This is the unit of measurement as it pertains to the listed ingredients.
6. Manufacturer, Packer, Distributor’s name and Addresses: Origin information of the product.

The consequences of violating the rules and regulations of the FDA can be crippling to any importer. Violations lead to seizure, detention, or even refusal of admission. 

Related: Customs Penalties and Fines

Ingredient Requirements

The FSVP requires importers to verify that their supplier analyzes potential risks. The program ensures that FDA standards are in place for cultivating and harvesting certain vegetables and fruits used in dietary supplements. 

Color additives used in dietary supplements need to be verified in terms of FDA compliance. These additives need to be pure, and clearly stated on the product’s label. 

You can view the FDA’s current list of approved color additives to determine whether your supplement complies with agency standards.

Manufacturing Facility Registration Requirements

The facility of origin must follow a set of parameters for exporting goods. Manufacturer facilities are mandated to register and maintain FDA standards. Along with these assurances, they must permit the FDA to inspect the facility if needed. 

Facilities must renew their registration every other year. If there are any health risk scenarios, the FDA can suspend an active registration. The federal government creates new laws annually, so checking for the latest changes is always essential.

As an importer, it is not your responsibility to register the food facility. They will need to go through the certification process before they can distribute products in the U.S. You can use the FDA’s list of approved facilities to find out if your supplier is already registered. 

To register as a manufacturer, the following data is needed:

1. Facility information: Name, corporate entity type, physical location, trade names used to do business
2. Contact Information: Telephone, email address, preferred mailing address
3. Product Information: To include any activities performed on their products 

Ensuring that a food facility is registered with the FDA is critical for importing goods regulated by this agency. The FDA Industry Systems (FIS) was instituted to carry out submissions, including registrations and listings. This service is publicly available 24 hours a day. 

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Import Dietary Supplements with USA Customs Clearance

As you can see, the process of importing dietary supplements takes multiple steps. Working with an experienced customs broker will help you avoid significant fines and delays. That’s where we come in.

The licensed customs brokers at USA Customs Clearance have years of experience assisting businesses and individuals like you with every aspect of the importing process. We can ensure that your shipment of supplements is properly documented with all the correct HTS codes and paperwork required by the FDA and CBP.

Our full list of services includes:

• One-on-one customs consultation sessions
• Fast and accurate customs brokerage
• Success bundles for new importers
• And more

Give us a call at (855) 912-0406 or submit a contact form online today. We have the know-how and expertise to supplement your importing business.