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 d...

Do you have a great idea for a food product? Or maybe you want to import your favorite food from overseas and introduce it to American consumers? If either of these scenarios describe you, congratulations! But before you move forward with your new business venture, you first need to be aware of a few things that govern food in the United States, especially when it comes to ingredients.

All businesses engaged in the manufacturing of foods must ensure that ingredients and substances added to their products are lawful under the laws and regulations administered by the U.S. Food and Drug Administration (“FDA”). Under the Food, Drug and Cosmetic Act (“FDCA”), foods are defined as:

• Articles used for food or drink, such as a apples or soda.
• Chewing gum.
• Articles used for components of those articles, such as food additives.
  (21 U.S.C. § 321(f))

Substances added to food must be either:

• FDA-approved food additives, which are substances having an intended use that results in their bec
...

When importing food, beverages, and dietary supplements into the United States after selling through Amazon, everything must comply with the FDA regulations for not only labeling and ingredients but claims as well. Your specialists here at US Imports are here to assist sellers with FDA compliance so they are not shut out of the largest market in the world – Amazon.

How do I sell legally on Amazon?

That is a great question! To start selling on Amazon legally, our Amazon Sellers Essentials Bundle has everything you need! There are several things that need to be completed including FDA Registration, U.S. Agent, FDA Label Review, FDA Claims Review, and FDA Prior Notice. Here is a little breakdown of what each one consists of.

• FDA Registration and U.S. Agent – Importers are responsible for designating an FSVP Agent upon entry of a food product into the United States. As an FSVP Agent, you must be a qualified individual that is physically located within the U.S. to serve as the importer
...

Mislabeling your products can harm your business's reputation and cause you to lose sales. Customers want to be able to find all the information they need without having to look hard for it. Moreover, similar to food and beverage, the FDA requires cosmetic products to be labeled properly. Below is a list of common labeling mistakes and how to fix them before you start selling your products.

Product Name

To prevent misbranding, you need to make sure the front of the label properly lists what the actual product is. For example, “Rose Scented Lotion” would be the proper name for a skin lotion that smells like roses because a fragrance is added to the product. However, if instead the label states “Rose Lotion” this would imply that the lotion contains roses and if it did not contain roses themselves the product would be considered misbranded.

Ingredient List or Not

FDA requires products that make at least one claim to include an ingredient list on the label. For example, if your product ...

Did you know that if your label doesn’t meet FDA requirements, it can cause a delay at the port? Label mistakes can have a huge impact on your Amazon business if you don’t know what you’re doing. How can you fix this? You can have your label reviewed by professionals well-versed in FDA labeling regulations. Sure, you could try to figure it out on your own, but is it worth the risk? At US Imports, our FDA specialists help minimize this risk by reviewing your label and providing suggestions to keep your labels compliant with U.S. laws.

How can US Imports help you?

We offer two FDA label review packages. Our Basic Package Label Review provides an extensive review of your label for FDA compliance. As part of this review, you will receive a detailed report with suggested changes to your label. Once you implement the changes, you can resubmit your revised label to us for another review to ensure the changes were made correctly.

Our Expert Package Label Review contains everything in the ...

You’ve worked hard caring about and developing your food product. You know what’s in it and you selected the best ingredients because it matters to you what goes into your customers bodies. But just because you think it’s “healthy” doesn’t necessarily mean you can label your product that way without knowing the law.

Whether you can call your product “healthy” depends on a number of factors. The first thing to figure out is what laws apply to your product. If you import food into the United States, you are most likely governed by the Federal Food, Drug, & Cosmetic Act and subject to the FDA’s definition of “healthy.” Most processed and packaged foods (excluding primarily meat and poultry products) will fall into this category. 

The term “healthy” -- or any similar term -- can only be used if your food meets certain nutrient requirements for total fat, saturated fat, cholesterol, sodium and certain other nutrients. Note that if your food does not meet the low fat requirement, the FDA w...

Imported food, beverage and dietary supplements offered for sale as “organic” in the United States must be certified by the U.S. Department of Agriculture’s (USDA) National Organic Program (NOP), or under a program with equivalent standards. Labeling products as organic that are not certified can result in refusal of entry into the U.S., fines for each violation and/or criminal enforcement actions. 

Imports can meet these standards in one of three ways:

1. The product was certified by an agency accredited through the NOP. Accredited agencies are listed in the USDA’s INTEGRITY database, available online.
2. The product was produced under an equivalency arrangement with a foreign country. The only countries with equivalency agreements with the U.S. are Canada, the European Union, Japan, Korea and Switzerland.   
3. The product was produced under a recognition agreement, which is an agreement with foreign countries that do not have equivalent organic standards. These agreements allow specifi...

If you’re creating a label for your food product, you may be inclined to include the word “natural” on it. But think twice before you do, as many food companies have found themselves at the wrong end of a lawsuit for stating "natural" on their label.

“Natural” is not synonymous with “organic.” The Food and Drug Administration (FDA) has yet to define “natural”, but any food product labeled as organic must comply with the requirements of the Organic Foods Production Act of 1990, which is administered by the U.S. Department of Agriculture. In short, this means that organic ingredients must be grown on land free of certain pesticides, and for meat products, animals cannot be given growth hormones. Many consumers do not know there’s a difference between organic and natural, but legislators, food lawyers and the courts do. Using “organic” when not appropriate can get you into trouble.

What does “natural” mean on a food label?

Businesses are routinely face lawsuits for making “natural” cla...

Food and beverages imported into the United States must comply with U.S. law which requires a Nutrition Facts Panel on every product label. Without a compliant Nutrient Facts Panel, your product may be detained upon entry at the U.S. port of entry. 

Every Nutrition Facts Panel must have the following:

1. Serving Information - the number of servings per container and the appropriate serving size
2. Calories - number of calories per package and per serving - this must be bolded and the largest font of the label
3. Nutrition - amount of macronutrients and certain micronutrients per serving 
4. Sugar - total sugars per serving and the amount of sugar added 
5. Daily Value  - the percentage of Vitamin D, Calcium, Iron and Potassium per serving
6. Ingredient List - list of all ingredients in descending order by weight and ingredients must be properly named

The Nutrition Facts Panel requirements were completely overhauled in 2018. Amendments to FDA regulations established new formatting requirement...

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 ...