Overcoming the unique challenges of importing dietary supplements to the United States can seem daunting. The various laws and regulations established by the Food and Drug Administration (FDA) are often difficult to understand and interpret. If you are planning on importing dietary supplements to the US, you need to be aware of the products, market trends, laws, and regulations, including the process in which to import them.
When importing dietary supplements into the U.S, the FDA strictly enforces federal laws. Specific FDA guidelines govern importing regulations, proper labeling, approved ingredients, and more. Taking care to properly file a prior notice before the shipment arrives at the port and securing a customs bond is essential.
Our guide below provides importers with everything they need to know about importing dietary supplements into the U.S.
Dietary supplements are products taken to supplement the human diet. Since 1994, dietary supplements have been identified as their own legal class of food by the Dietary Supplement Health and Education Act (DSHEA). As determined by the Food Drug and Cosmetic Act (FDCA), dietary supplements are consumable foods. Regardless, “nutritional supplements are not considered conventional foods like bananas, nuts, or tomatoes.”
Consumers see herbal supplements as a necessary addition to any health condition. An example use case would be supplements taken to help prevent heart disease. These supplements come in various forms, including powders, capsules, tablets, drinks, or energy bars. Different supplements provide nutrients, weight loss, energy enhancement, or even alertness to the human body.
In a survey conducted by Consumer Lab Survey, we can see a list of the most popular dietary supplements. This survey was conducted by over nine thousand participants here in the U.S. to ascertain what supplements they purchased most.
It is essential when importing supplements to know which ones are the most desirable. Also, having a numerical value tied to it can help give an idea of which types of supplements to import. These numbers are not fixed but can help with gaining an understanding of recent trends.
|Supplement Name||Percentage of Survey Respondents That Purchased Within the Past Year|
|Fish Oil - Omega 3||52.5%|
|CoQ10 - Ubiquinol||45.7%|
|Curcumin - Turmeric||34.8%|
The compound annual growth rate (CAGR) of dietary supplements grows year over year. The global market itself exceeds $151 Billion dollars annually, with the U.S. accounting for a sizable share. The dietary supplements market is expected to maintain a steady growth up through 2030.
The U.S. has become a market leader in the expansion and growth of this FDA food category. Careful planning and execution are required in order to benefit from importing dietary supplements. The table below will help illustrate the steady annual growth of dietary supplements in the U.S. alone.
In answer to the question, “does the FDA approve dietary supplements?” The answer is no they do not approve them. Instead, the organization enforces regulations that all parties involved must comply with. The responsibility for meeting FDA guidelines rests with the company that introduces a product to market.
Companies must ensure that the available information is correct and not misleading. The rules enforced combat fraud, false advertising, mislabeling, and reports of harmful side effects.
Regulations put into practice by the FDA serve as a way of “policing” the industry. New products flood the market constantly, creating a challenging environment for the FDA. Thus, regulating dietary supplements instead of approving them is the standard.
The responsibility entirely rests with the firm that produces the dietary supplement. They are responsible for ensuring that they deliver a safe and sanitary product. It is up to the importer, to ensure that the products you’re importing are compliant with FDA regulations.
The FDCA declares dietary supplements as foods regulated by the FDA. As stated above, approval or permits are not required by the FDA. Instead, the facility that produces, packs, and ships the product must adhere to regulations. The FDA is not authorized to certify or approve individual food importers, products, or shipments.
If you wish to import a product into the U.S., you can do so without prior sanction by the FDA. You can only do this as long as specific requirements are followed. If any of the ingredients are of animal origin, you’ll need to obtain a permit. You can apply for a permit directly from APHIS (Animal and Plant Health Inspection Service).
When importing dietary supplements into the U.S., the FDA has specific regulatory requirements for the importer. In addition to meeting the requirements of the FDA, importers must follow the various U.S. import procedures..
Importers must consult an agent physically located in the United States. Once consulted, an agent can verify their foreign suppliers’ compliance with the FDA. Some necessary regulations to consider are Prior Notice (PN), Good Manufacturing Practices (GMP), and the Foreign Supplier Verification Program (FSVP).
Every import shipment of dietary supplements requires prior notice filed with the FDA. The notice must be filed before the product arrives at its port of entry. Upon receiving prior notice, the FDA will issue a confirmation number in the bar code required to accompany food shipments.
Prior notice will include the following information:
Anyone with knowledge of the shipment can file prior notice. The filing can be done by the exporter, importer, or even a third party (logistics or manufacturer). Knowing when to submit prior notice is critical to avoid risks or penalties to a shipment. Also, a valid registration from the product’s manufacturer.
When to submit Prior notice:
Penalties and risks for not filing prior notice:
Prior notice for International Mail should be submitted before the food is shipped. However, the FDA should not receive notification any more than 15 days before shipping.
Filing is done through the Prior Notice System Interface (PNSI) located on the FDA website. A customs broker can ensure the reduction of filing errors and expedient filing time. A broker will handle the Automated Broker Interface of the Automated Commercial System (ABI/ACS).
GMP ensures that the practice of “industry condition standards” that we follow in the U.S. are also followed by foreign manufacturers. GMP is another stopgap to ensure that products are safe.
GMP standards cover the following areas:
The FDA regulates GMP; the CBP enforces federal immigration and customs laws on or near the border. Border management and control is the primary purpose of the CBP, which is an organization under the Department of Homeland Security.
In 2011, President Barrack Obama signed the Food Safety Modernization Act (FSMA). FSVP aims at providing assurance and accountability to foreign suppliers. The general purpose of FSVP is to serve as a “passport” to goods imported into the U.S. market.
Essential FSVP requirements include:
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.
It is imperative to follow all rules prescribed by the FDA. Failing to follow these requirements can and will lead to negative consequences that can seriously affect your import timetable. Penalties for not following FDA Import requirements are due to the following.
The FDA has strict requirements for food goods that are packaged, baked, or canned to be labeled correctly. The label format should include the following:
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. Label violations will lead to the denial of imported goods. Thousands of labeling violations occur annually, leading to multiple courses of action by the FDA.
The FSVP program 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.
Certain color additives that may be used in dietary supplements need to be verified in terms of FDA compliance. Supplement ingredients need to be pure without the misbranding of any elements. You can view the FDA’s current list of approved color additives to verify your supplement’s compliance.
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.
Mandatory renewals of the registration are required every other year by the FDA. 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.
You only need to register if you manufacture, process, pack, or store dietary supplements. The FDA requires the following data for Manufacturing registration.
As an importer, it is not your responsibility to register the food facility. However, you will need to ensure that the facility is registered with the FDA. Importers can use a web-based tool to look up the registration of any facility.
Ensuring that a food facility is registered with the FDA is critical for importing goods. The FDA Industry Systems (FIS) was instituted to carry out submissions, including registrations and listings. The service is publicly available 24 hours a day.
Even though it is mandated for food manufacturers to register their facilities with the FDA, some facilities are exempt.
Below is a list of some facilities that are exempt from registration:
Violations of the FSVP can occur and are not uncommon. If a facility is subject to FSVP requirements, it must exercise every necessary precaution to ensure it remains in compliance.
Listed below are some examples of FSVP violations:
Noncompliance with the FSVP rule can lead to stiff penalties regardless of whether you are an importer or exporter.
As you can see, the process of importing dietary supplements can seem daunting. Luckily, USA Customs Clearance offers a full range of services to assist you. Customs Bonds are essential to importing goods into the U.S. It is critical that import fees and taxes are correctly handled. We can help you with this task by providing you with a continuous customs bond.
Before importing goods into the country, you will need to become a registered importer with CBP. By purchasing an importer of record registration, you get accurate and speedy filing from our licensed customs brokers.
If you have no experience with importing goods or feel uneasy, we offer multiple packages to help. Our New Importer Success Bundles are the perfect all-in-one solution to get you started. We have consultants waiting to provide you with their expertise and get you in the right direction now. You can contact us at (855) 912-0406 to get started on importing your dietary supplements today.