Guide to Importing Dietary Supplements

dietary supplements fsvp ingredients labeling nutrition facts prior notice Oct 18, 2024

When importing dietary supplements into the United States, importers must comply with the U.S. Food and Drug Administration (FDA) regulations. Specific FDA regulations govern proper labeling, approved ingredients, and more. Taking care to properly file a Prior Notice before the shipment arrives at the port is essential.

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

What are Dietary Supplements?

Dietary supplements are foods that are orally ingested, usually in the form of a pill, tablet, capsule, gummy, liquid concentrate, powders, drinks or energy bars. They are taken to supplement the diet, promote general health and well-being, and affect the structure or function of the human body (like drugs). Dietary supplements must be ingested, so they are never topical creams, ointments, or oral or nasal sprays. The FDA will review how a product is marketed when classifying how to enforce its standards and failing to differentiate a dietary supplement from a conventional food, cosmetic or drug could lead to FDA regulatory action against the importer.

Legal and Regulatory Matters

The FDA does not "approve" dietary supplements. Any claim otherwise if false. The responsibility to meet FDA requirements falls on the importer bringing the product to market.

The primary issues of concern for importers of dietary supplements are: advertising and marketing claims, label compliance, ingredient safety, Good Manufacturing Practice (GMP) regulations, notification filing to FDA, and United States Department of Agriculture (USDA) permitting requirements that apply to some dietary supplement ingredients. Manufacturers, packers and storage facilities in the supply chain must be registered with the FDA. Additionally, all importers and manufacturers must comply with Foreign Supplier Verification Program (FSVP) rule.

Permitting

Prior approval or permits are not required by the FDA. Compliance with U.S. laws and regulations are expected before importing. Failure to do so can be costly.

Labeling Requirements

FDA regulations require dietary supplements to be labeled with specific elements. The label should include the following:

Statement of Identity: The product name properly displayed on the principal display panel (PDP) of the label.
Supplement Facts Panel: This is the nutrition label for a dietary supplement, which includes the source of the ingredients, including the part of the plant where the ingredient comes from.
Country of Origin: This is mandatory for all dietary supplement products sold in the U.S.
Ingredients List: A detailed listing of all ingredients contained in the product.
Net Quantity Statement: The declaration of the amount of a product in a package.
Manufacturer, Packer, or Distributor’s Name and Address: Origin information for 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.

Ingredient Requirements

Dietary supplements must contain one or more dietary ingredients, such as vitamins, minerals, herbs or other botanicals, amino acids, or other substances. Manufacturers, importers, and distributors are responsible for substantiating that their products are safe, sanitary, and unadulterated with adequate evidence; this also applies to bulk ingredients. For dietary supplements already on the market, FDA bears the burden of proof that a supplement is unsafe. However, for imported bulk dietary ingredients, the level of evidence needed is very low (only the appearance of a violation is necessary for detention or refusal).

Claims

A claim is any representation that is made about a product. Unlike a label, a claim can be anywhere that the product is marketed, on a website, social media, flyers, or even advertisements on TV. A claim could be a variety of things, such as “100% Organic” or “All Natural.” These particular claims are permissible so long as your product qualifies. Some claims are preapproved by the FDA and others are allowed if they are truthful and do not mislead consumers. Making a false claim is something that will destroy the credibility of not only your products but your business as well. If you happen to make a false claim on your product, your product may be deemed misbranded by the FDA and denied entry into the US. You may even face lawsuits if you make a false claim and your customers find out the claim is not true.

Facility Registration

All dietary supplements offered for import into the US must be made at an FDA Registered manufacturing facility. Facilities must renew their registration every other year. If there are any health risk scenarios, the FDA can suspend an active registration. If the facility does not have employees in the US, then it must appoint a FDA Agent to act as their liaison with the FDA.

Good Manufacturing Practice (GMP) Standards

All foreign dietary supplement manufacturing facilities producing products for the US market are subject to FDA inspection for compliance with GMPs. Compliance with GMPs ensures consistent manufacturing of products in terms of identity, purity, strength and composition. GMPs include proper procedures for cleaning plants and equipment, proper manufacturing operations, quality control procedures, product testing and maintaining proper records.

Foreign Supplier Verification Program (FSVP)

The FSVP requires all food importers to verify that their foreign suppliers produce food in accordance with US standards. If you are a US importer and your dietary supplements are coming from a foreign supplier, you must have an FSVP Plan in place before importing your products. If you do not have a qualified representative in the US, then you will need to appoint an FSVP Agent. The FSVP Agent must be physically located in the US and will act as your company’s liaison with the FDA. Recently the FDA has been cracking down on importers who fail to have an FSVP Plan and maintain an active FSVP Agent in the US, and is now one of the main reasons for dietary supplements being denied entry into the US markets.

Conclusion

Here at US Imports, we can take care of the small stuff so you can focus on the big stuff, like growing sales in the US. Let us help your business maintain compliance. Check our services to learn more.