When importing dietary supplements into the United States, importers must comply with the U.S. Food and Drug Administration (FDA) regulations. Specific FDAÂ 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.
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 (âFDAâ). Under the Food, Drug and Cosmetic Act (âFDCAâ), foods are defined as:
Substances added to food must be either:
Have you ever seen a claim made on a food, beverage or supplement label that seemed too good to be true? Unfortunately, this happens all the time. However, the companies producing these products wonât get away with it for long. The FDA has strict rules for claims made on labels. If your label does not adhere to these rules, you may be subject to serious consequences. In this article, weâre going to cover what a claim is, what happens if you make a false claim, and how US Imports can help.
A claim could be a variety of things, such as â100% Organicâ or âAll Natural.â 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. An example of a preapproved health claim would be âyou can reduce your risk of osteoporosis with physical daily exercise, vitamin D, and calcium.â This claim is backed by scientific data and has been proven by scientist...
Mislabeling your products can harm your business's reputation and cause you to lose sales. Customers want to be able to ďŹnd 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 ďŹx them before you start selling your products.
To prevent misbranding, you need to make sure the front of the label properly lists what the actual product is. For example, âRose Scented Lotionâ 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 âRose Lotionâ this would imply that the lotion contains roses and if it did not contain roses themselves the product would be considered misbranded.
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 doesnât meet FDA requirements, it can cause a delay at the port? Label mistakes can have a huge impact on your Amazon business if you donât know what youâre 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.
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 ...
Food products imported into the United States must have an ingredients statement declaring all ingredients contained in the product. But itâs not as simple as a mere declaration. FDA regulations require that ingredients be listed in a certain order, named in the correct manner, and placed on a specific location on the packaging. Therefore, it is not a given that you can simply use the productâs existing ingredient list. You must review the ingredient statement for FDA compliance.
Complying with U.S. labeling requirements is not just a matter of common sense, nor is compliance something that can be done after your import deal is inked. As you will see below, FDA regulations require a meticulous examination of every ingredient to determine the proper placement, nomenclature and other ingredient statement requirements. Â
Failing to comply can be very costly. Ingredient errors and omissions are one of the top reasons for food being denied entry into the United States. Inaccurate ingredie...
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