Dietary Supplements in the U.S. Staying Alert as a Consumer
The Figures That Count Dietary supplements are a $23.7 billion industry in the United States.
Over 70 percent of the U.S. population has tried at least one dietary supplement.
In the past 6 years, FDA has identified over 400 dietary supplement products that were illegally manufactured, misbranded, or falsely labeled.
FDA and DSHEA Join Hands to Help Regulate the Industry
The Dietary Supplements Health and Education Act - 1994
DSHEA defines the term "dietary supplement" to mean a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients: a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance for use by man to supplement the diet by increasing the total dietary intake, or a concentrate, metabolite, constituent, extract, or combination of any of the aforementioned ingredients.
Regulatory Hurdles
Federal law does not require dietary supplement manufacturers to seek approvals before production nor before marketing the products.
Product advertising too comes under the jurisdiction of the Federal Trade Commission.
The products have to reach the marketplace before they fall within the FDA’s perimeter.
DSHEA does not set limit levels for vitamins and minerals that can be incorporated in a pill.
FDA too has but a limited capacity to monitor adverse reactions from these supplements.
FDA 5 elements to be present in dietary supplement labels
Ingredient list Nutrition labelling Net quantity of contents statement amount of the Statement dietary of identity - supplement name of the dietary supplement
Name and place of business of the manufacturer, packer, or distributor
Stay Informed, Stay safe www.complianceonline.com/fda-regulatory-compliance-training FDA Safety Alerts and Recalls Page: FDA Safety Alerts and Recalls Forum to Report Adverse Effects: Adverse Events