The U.S. FDA, or Food and Drug Administration, is responsible for approving drugs, biologics, medical devices, veterinary products, tobacco products, and electronic products that emit radiation. It doesn't approve certain categories of food, beverages, and dietary supplements. This means if a company wants to market conventional food or dietary supplements, it wouldn't have to go through the FDA process of approval.
However, FDA has become strict with its regulatory policy for the categories that don't require approval. They have set directives for companies selling products (like conventional food and dietary supplements) and expect them to meet dietary supplements compliance. If, at any point in time, the company fails to comply with the rules, it must face strict actions by the administration. This may include warning letters, import refusals or alerts, suspension of registration, or penalties.
What is a Dietary Supplement?
A dietary supplement stands for an oral product with one or more ingredients that are intended to supplement a diet. They are available as pills, drinks, powders, capsules, or food. Some common examples of dietary supplements are vitamins, minerals, herbs, and related ingestible preparation.
How Does FDA Classify a Product?
FDA looks for the intended use of a product to classify it for approval. Intended uses stand for the use of the product that's claimed on the label.
The administration checks for ingredients, labeling, promotional materials, etc., to determine the intended use. Based on the categories to which the product belongs, the FDA decides on the approval process.
Conventional food and dietary supplements are two categories that don't require pre-market approval by FDA. The conventional category includes traditional food like fruits, seeds, legumes, nuts, etc. Meanwhile, dietary supplements include products that are added to the diet.
Product Compliance Requirements
For U.S Facilities
FDA product compliance requirements for the U.S facilities include:
- Registration of the Food Facility
- Registration Renewal
Registration of the Food Facility
In the Public Health Security & Bioterrorism Preparedness and Response Act of 2002, several provisions were introduced to enhance the food safety efforts of the FDA. The FDA was also directed to enact rules for facility registration. This includes the facilities that are responsible for producing, processing, or packing food, along with beverages and dietary supplements.
Meanwhile, personal residences, farms, trading companies, or any USDA-regulated facilities were free from such registration requirements.
After registering the facility, the company must renew it every two years of their registration. If they fail to do so, their facility registration may get canceled by the authorities.
For Non-U.S Facilities
Meanwhile, for non-U.S facilities, the compliance requirements are as follows:
- Appointing a U.S. Agent
- Prior Notice
Appointing a U.S. Agent
If any non-U.S facility wants to get registered with the FDA, they must appoint a U.S. agent for the process. The agents will be responsible for handling everything related to FDA inspection. They will acknowledge FDA actions, pay the re-inspection fees, and ensure better communication throughout the process.
If a non-U.S. company wants to ship any products or samples to the U.S., it must submit prior notice to the FDA about the same. If they fail to file the notice, the product may get detained at the port.
A prior notice can be filed by the exporter, importer, or any third-party source. It should include all relevant details concerning the shipment process and the facility.
What are the Requirements for Dietary Supplement Labeling
Dietary supplement labeling requires:
Statement of Identity: A statement of identity must include the product name and its declaration as a dietary supplement. The term dietary in the product may be replaced by any ingredients that are present in it.
Net Quantity of Contents: The Net Quantity of Contents is the total amount of consumable items in the product. It's displayed at the bottom of the package on the principal display panel. The Net Quantity of Contents does not include packaging weight.
Supplements Chart: Supplement charts contain the details about dietary ingredients in the serving size and servings per container.
Ingredients List: The ingredient list contains all the ingredients in the product according to their prevalence. However, if every ingredient is covered in the supplement facts panel itself, an ingredient list may not be required.
Domestic U.S mail address and contact number to notify any adverse effects of products
It's important for the facility/company to inform the FDA first about any serious side effects faced by the customers.
Types of Dietary Supplement Claims
Nutrient Content Claims - Nutrient Content Claims denote the nutrient amount present in the product. The nutrient level can be high, low, or free, or it can be compared with another food. Based on the comparison, it can be listed as lite, more, or reduced.
Health Claims - Health claim is a claim by the manufacturer that implies the food/food component in the product can reduce the risk of a certain disease or health condition.
Structure Function Claims - It denotes the role of a nutrient or dietary ingredient and its effect on the structure/function of the human body.
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