The import, marketing and sale of food supplements in the United States is regulated by the FDA [Food and Drug Administration] - Food supplements intended for sale in the US must comply with all the regulations issued by the FDA for this type of products
There are two crucial issues for the sale of food supplements in the US: the admissibility of the ingredients/components and the product claims made on the label
ExportUSA offers a complete compliance service for food supplements to be imported into the United States, in full compliance with the FDA regulations on the matter
The FDA compliance services offered by ExportUSA avoid the seizure of the goods at customs and selling in the US without problems
There are no stringent FDA regulations pertaining to the strict definition of dietary supplements, what types of products can be considered "food supplements", or the administration methods
This state of affairs represents an opportunity but also a risk because in the absence of specific directives it is often necessary to interpret the legislation to understand if a supplement can be considered compliant with the law
The FDA regulation on the sale of food supplements is very "flexible".
In essence, food supplement manufacturers have a lot of independence in deciding what can be considered a supplement, areas of application of supplements, purposes and indications, form, doses, ingredients/components, and so on.
The FDA has set strict parameters on four specific factors:
FDA Regulations on Product Claims on Food Supplement Labels for Sale in the US
The FDA's intent is to prevent dietary supplements from encroaching on the medical field by promising a cure for a disease.
The promise of a cure can be made explicitly ["this product prevents osteoporosis"], or implicitly through the use of images, product names ["OsteoFix"], and references to medical practices not directly related to the supplement on the market.
Sometimes the claim, namely, the promise of results made on a label, while not promising a "cure" in the medical sense of the term actually crosses into the medical field. This is because the claim made has been so connected to a disease that it has become a de facto promise of a cure.
Even the use of some components automatically turns the dietary supplement into a drug according to the interpretation of the FDA.
The FDA compliance service offered by ExportUSA ensures a fast and hassle-free customs clearance by the FDA, thus avoiding the risk of customs seizure when importing to the US.
- Eligibility of ingredients used in the production of food supplements. At minimum, they must be "not prohibited" ingredients and used in the percentages and concentrations allowed for the declared use [the same ingredient used in a cosmetic cream can be used in higher concentrations than in the case of the same ingredient used in a supplement to be ingested ].
- The product claims made on the main label. The claims must not be such that they make the product cross over into the medicine class [if I say that a supplement reduces cholesterol, I automatically place it in the category of medicines, and if I want to keep the claim on the label I will have to register the product as a medicine and no longer as dietary supplement.
- Color additives and preservatives. Here, too, color additives and preservatives must be those permitted for the marketing of food and dietary supplements in the United States.
- Allergens. They are classified into one of the eight allergen classes coded by the FDA. If the food supplement to be imported and marketed in the United States of America contains allergens, these must be explicitly declared on the label.
It is therefore essential to carefully evaluate the four elements indicated above to ensure that the supplements to be exported to the US are compliant with the applicable requirements.
Definition of a dietary supplement according to the FDA
A food supplement is a product to be taken by ingestion containing "dietary ingredients", and whose purpose is to supplement the ingredients that are taken in with one's daily diet. Food supplements can be any of the following, either alone or in combination with each other:
- herbal substances
- active ingredients
- amino acids
Food supplements can take different forms, such as: pills, capsules, tablets, gels, gel capsules, liquids or powders.
The FDA compliance services offered by ExportUSA
To ensure complete compliance with FDA requirements, ExportUSA offers the following services to Italian producers who seek to export food supplements to the US:
- Analyses of admissible ingredients;
- Dyes and preservatives admissibility analysis;
- Identification of allergens if any;
- Label revision;
- Preparation of Supplement Facts. As for foods, tables with Supplement Facts must also be prepared for food supplements [for food products, they were called Nutrition Facts until a few months ago, when they were replaced by a Nutrition Label, but it is simply a change of name]
ALL the steps listed here are required to ensure complete and correct compliance of food supplements to be imported into the United States.
The label revision and compliance offered by ExportUSA also extends to informational, promotional and sales material. The scope of the FDA regulation on food supplements also extends to package inserts, leaflets, brochures and websites.
FDA Registration and FDA Agent Appointment to Import Dietary Supplements to the US
What has just been listed has to do with bringing to compliance the supplement to be exported to the US. At the company level, however, it is also necessary to complete the FDA registration of the manufacturing and exporting company [if the company that exports is different from the company that produces] in order to receive an FDA number. The appointment of the FDA Agent will also be required during FDA registration. These steps are the same required by the FDA for companies producing and exporting food products.