Q1 What are dietary supplements?

Dietary supplement is a product for consumption containing one or more dietary ingredients: vitamins, minerals, herbs or other plants, amino acids, dietary substances that are supplemented by increasing total intake, or concentrates, metabolite, ingredients, extracts or combination products of the above substances.

There are two categories of ingredients that can be used in dietary supplements: "dietary ingredients" (as described above) and "other ingredients". "Other ingredients" include fillers, binders, excipients, preservatives, sweeteners and spices.

Dietary supplements come in a variety of forms, such as pills, tablets, capsules, gummies, softgels, liquids and powders, and can also come in the same forms as traditional foods (general foods).

Q2 What should manufacturers mark on the label of dietary supplement?

The label of dietary supplement should include:

• Product name, with a note of "dietary supplement", or by replacing "dietary" with the name or type of dietary ingredient in the product (for example, "iron supplement" or "herbal supplement");

• Name and place of business of the manufacturer, packer or distributor;

• Dietary composition table;

• List of "other ingredients" not marked in the dietary composition table;

• Net content.

In addition, dietary supplement labels should be marked a U.S. address or telephone number for reporting serious adverse events to the manufacturer, packer or distributor identified on the label.

Q3 Do dietary supplement labels have to list all ingredients?

Yes, ingredients not listed in the "dietary composition table" should be marked in the "other ingredients" below.

Q4 Is serving size for dietary supplement standardized? Or is there a limit on the amount of a dietary ingredient in a serving?

There is no law or regulation that limits the serving size of dietary supplements or the amount of dietary ingredients in dietary supplements. Manufacturers can set their own and FDA approval is not required.

Q5 What types of claims can be indicated on dietary supplement label?

According to regulations, three types of claims can be used on dietary supplement labels: health claims, structure/function claims and nutrient content claims. Each claim has different requirements.

In addition, similar to traditional foods, dietary supplements can make claims on their labels that are not stipulated by law or regulation (e.g., flavor claims), which should be truthful and not misleading.

Q6 Why are some dietary supplement labels indicated "This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease"?

Under 21 CFR 101.93, if there are structure/function claims or certain specific claims on a dietary supplement label, this disclaimer should be indicated on the label to inform consumers that the FDA has not evaluated the claim. The disclaimer should also state that this product is not intended to "diagnose, treat, cure, or prevent any disease", as only medicine can legally use such claims.

Source: Sina

Note: This article is compiled by Antion. Please indicate the source for reprint.