What to Consider Before Selling Dietary Supplements in the U.S.

claims dietary supplements fda registration labeling trademarks Jul 08, 2021

Dietary supplements imported into the United States are governed by a complex body of laws and regulations. These laws and regulations govern manufacturing practices, product and ingredient safety, labeling, marketing claims, importing procedures, among other things.

Failure to comply can result in regulatory action by the U.S. Food and Drug Administration (FDA), including product detentions, warning letters, refusals of entry at U.S. ports, and fines. This is why it is imperative to be familiar with these laws and regulations before importing dietary supplements to the U.S.,.

FDA Facility Registration

All dietary supplement products offered for import must be manufactured in a facility register with the FDA. If the facility is located outside of the United States, you will need to appoint a U.S. Agent physically located in the U.S. to handle communications with the FDA. Upon registration, you will receive an FDA facility registration number. This number is important for confirming your facility registration with U.S. Customs, wholesalers, retailers, and other parties.

Labeling Requirements

Dietary supplement labels must comply with specific rules to avoid being deemed misbranded by the FDA. For example, labels must be in English but they may also contain another language so long as each statement in the foreign language is listed in English. Labels must also contain the following: (1) statement of identity (i.e., the common name of the product), (2) net quantity, (3) supplemental facts, (4) ingredient list, and (5) the name and place of business of the manufacturer, importer, packer, or distributor. If the supplements are manufactured in another country, then the label must state the origin of the product. Labeling rules are complex, so it’s best to get your labels reviewed by a labeling specialist before shipping to the U.S.

Labeling Claims

A claim is any representation made about a product on the label, website, flyer or even social media. Labeling claims face several restrictions under FDA regulations. This prohibits products from making untrue or misleading claims and protects consumers. If your claims do not comply with FDA regulations, the label will be considered misbranded and your dietary supplements will be denied entry into the U.S. Labeling specialist can assist to review claims to ensure they comply with FDA regulations.

Trademark Your Product

It’s vital for businesses to register their trademark in order to protect their brand from competitors. A trademark can be names, slogans, logos, or any other recognizable marks that distinguish your brand and product from the competition. Foreign registered trademarks are not recognized in the United States, so before importing your dietary supplements make sure to file an application to register your mark with the U.S. Patent and Trademark Office (USPTO). The registration process can take up to a year, so it’s best to apply as soon as you start importing.

Takeaway

There are many hurdles to overcome before a dietary supplement can hit the market and if you are importing dietary supplements into the U.S., the to-do list is even longer. US Imports can help prepare your importing business for success. We offer services to assist importers to meet their compliance needs, including trademark registration, label and claim reviews, and FDA facility registration, among others. For more information, visit www.usimports.us/dietary-supplements.