The FDA does not approve food, beverages, or dietary supplements in the United States. Pre-market approval is not required by the Agency for any conventional food or dietary supplement. As a result, corporations are not required to submit product information or labeling to the FDA. They do not require an inspection before marketing their items. The FDA, on the other hand, expects businesses to follow the rules and regulations in place.
Companies that do not comply with the laws and regulations may face FDA enforcement actions such as inspections, import refusals, import alerts, warning letters, registration suspension, and/or civil and criminal fines. With regulatory agencies taking a tougher approach to enforcing regulatory policies, procedures, and GMP compliance, businesses must ensure that their products conform with the most recent regulations.
What Exactly Is a Dietary Supplement?
The legislation defines dietary supplements as products used orally that contain a “dietary ingredient”. Vitamins, minerals, amino acids, herbs or botanicals, and other substances that can be utilized to supplement the diet are examples of this.
Product Classification by the FDA
The FDA has the authority to classify a product depending on its intended purpose. The FDA regulates the following products: traditional food or beverage, dietary supplement, medication, and cosmetics.
The claims made about the product in its labeling, advertising, promotional material, or any other applicable elements can be used to identify its intended usage. It can also be determined based on the product’s ingredients.
Conventional foods are those that are consumed in their traditional form, whereas dietary supplements are foods that may assume a different shape. Fruits, legumes, nuts, seeds, whole grains, seafood, and other typical foods are examples of conventional food.
Dietary supplements are available in a variety of formats, including pills, capsules, powders, energy bars, and liquids.
Requirements for Product Compliance
The Food Facility’s Registration
Following the events of 9/11, Congress passed the Bioterrorism Act of 2002. The Act required the FDA to issue regulations requiring the registration of any facility that manufactures, processes, or packs food, including drinks and dietary supplements. Trading companies, personal residences, transportation only providers, farms, retail food establishments, fishing vessels, and USDA-regulated facilities, on the other hand, are free from registration.
Companies must renew their registration every two years, on the even-numbered years. Failure to renew the registration may result in the registration being canceled.
Non-U.S. Facility Compliance Requirements
Appointment of a U.S. Agent
When registering, facilities located outside the United States must choose a U.S. Agent. It contains a verification step in which the US agent approves the designation. The agent is in charge of coordinating an FDA inspection, responding promptly to FDA actions and communications, and paying the FDA re-inspection fees.
Companies based outside the United States must notify the FDA in advance of any cargo they send to the United States. The exporter, importer, or a third party may file the notice. Even samples require this notification. Failure to file the notice may result in the product being held in the port. The notification must include details about the facility and the shipment.
Labeling Requirements for Dietary Supplements
The minimum labelling requirements are as follows:
The product name and identification as a dietary supplement must be included in the statement. Although the term dietary can be replaced with the type of ingredients in the product, having one of them on the product label is a legal necessity. Based on its actuals, the product must be labelled as either conventional meals and beverages or dietary supplement.
Net Contents Quantity
The net quantity of content tells consumers how much dietary supplement is in the container or packet. The net amount of content must be displayed on the product label as a distinct item in the bottom 30% of the main display panel in lines often parallel to the container’s base.
The supplement information must provide a list of the names and amounts of dietary components found in the product’s serving size’ and ‘servings per container.’ Please keep in mind that dietary facts charts and nutrition data charts differ.
List of Ingredients
The elements must be listed in descending order of weight predominance. An ingredient statement is not required if all source components are included in the supplement information panel and there are no extra ingredients, such as excipients or fillers.
Other information required includes the name and address of the maker, packer, or distributor, as well as a domestic U.S. mail address and phone number to which a customer can report a major adverse event. When an adverse event is reported, the company is required to notify the FDA.
Understanding the Different Kinds of Dietary Supplement Claims
Nutrient Content Claims Nutrient content claims explain the level of a nutrient in the product using terms like free, high, and low, or they compare the level of a nutrient in one item to that of another using terms like more, reduced, and lite.
Health claims highlight the reduction of disease risk associated with the ingestion of a certain nutrient.
Claims Regarding Structure and Function
Structure function assertions describe a nutrient’s role or method in influencing the structure or function of the organism. They may describe how a vitamin or dietary item operates to preserve such structure or function.