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How Supplements are Regulated

 

With more than 150 million Americans taking dietary supplements each year, consumers need assurance that the supplement industry is adequately regulated. The fact is dietary supplements are subject to detailed and comprehensive regulations to safeguard safety and quality.

 

 How Dietary Supplements are Regulated
View PDF: How Dietary Supplements Are Regulated

 

Sources:

1. www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/ucm148035.htm
2. www.fns.usda.gov/fdd/facts/nutrition/foodallergenfactsheet.pdf
3. www.fns.usda.gov/fdd/facts/nutrition/foodallergenfactsheet.pdf
4. Section 415 of the FD&C Act, 21 U.S.C. 350d.
5. Section 414 of the FD&C Act, 21 U.S.C. 350c.
6. Section 801(m) of the FD&C Act, 21 U.S.C. 381(m).
7. www.fda.gov/food/DietarySupplements/default.htm
8. http://thomas.loc.gov/cgi-bin/bdquery/z?d101:HR03562:@@@D&summ2=m&
9. www.ftc.gov/os/statutes/fpla/outline.shtm
10. www.fda.gov/RegulatoryInformation/Legislation/default.htm

How are supplements regulated?

Regulatory authority for dietary supplements is rooted in the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) through the FTC Act and the Federal Food, Drug and Cosmetic Act (FFDCA), which was further strengthened in 1994 by the Dietary Supplement Health and Education Act (DSHEA). The FTC pursues deceptive, false and misleading advertising. The FDA is charged with inspecting manufacturing facilities, reviewing labeling and monitoring products for safety.

While the FDA once required dietary supplements to meet the same good manufacturing practices (GMPs) as foods, that policy changed in 2007. Today, the FDA’s new GMPs for dietary supplements impose higher standards and are working to ensure supplements are produced in a quality manner and are accurately labeled. The new GMPs became required for large manufacturers in 2008 and are now in effect and being enforced for all manufacturers.


What laws directly impact dietary supplements?

Dietary Supplement and Nonprescription Drug Consumer Protection Act: This 2006 act was passed to amend FFDCA (see below) with respect to serious adverse event reporting for dietary supplements and nonprescription drugs, in addition to other purposes.1 The law requires that the manufacturer, packer or distributor of a dietary supplement or over-the-counter (OTC) drug notify the FDA of all serious adverse events it receives associated with their dietary supplement or OTC within 15 business days. Serious adverse events are defined as those that result in death, a life-threatening experience, in-patient hospitalization, a persistent or significant disability or incapacity, congenital anomaly or birth defect, as well as situations where medical/surgical intervention is required to prevent the previously listed events.

Food Allergen Labeling Act (FALCPA): FALCPA went into effect in 2006 and requires manufacturers to clearly identify on their food labels if a food product has any ingredients that contain protein derived from any of the eight major allergenic foods and food groups: milk, eggs, fish, Crustacean shellfish, tree nuts, peanuts, wheat, or soybeans.2

Bioterrorism Act: Title III of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 gave the FDA additional statutory enforcement powers to increase food security in order to reduce the threat of bioterrorism. The FDA was provided with increased regulatory authority over the food supply,3 registration of food facilities,4 recordkeeping requirements and records inspection authority,5 and prior notice of imported food shipments.6 All provisions apply to conventional food and dietary supplements.

Dietary Supplement Health and Education Act (DSHEA): The FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products (prescription and over-the-counter). Under DSHEA, which was passed in 1994, dietary supplements that were in commerce prior to 1994 are broadly presumed safe. For these supplements, manufacturers do not need to register their products with the FDA nor get FDA approval before producing or selling them. Manufacturers must make sure that product label information is truthful and not misleading. For these products, the FDA is responsible for taking action against any unsafe or misbranded dietary supplement product after it reaches the market. All new ingredients marketed within dietary supplements after 1994 that are not found in food must meet a stricter set of regulations and notification prior to release in the marketplace.7

Nutrition Labeling and Education Act (NLEA): Signed into law in 1990, NLEA, among other things, set standards for allowing health claims on foods (including dietary supplements) if the claims are based on sound scientific evidence and are truthful, accurate and not misleading.8

Fair Packaging and Labeling Act (FPLA): Enacted in 1967, FPLA requires that all "consumer commodities" be labeled to disclose the identity of the commodity- the name and place of business of the product's manufacturer, packer or distributor- as well as the net contents in terms of weight, measure or numerical count (measurement must be in both metric and inch/pound units).9

Federal Food, Drug, and Cosmetic Act (FFDCA): Passed in 1938, FFDCA completely overhauled the public health system. Among other provisions, the law authorized the FDA to demand evidence of safety for new drugs, issue standards for food, and conduct factory inspections.10 Under FFDCA, dietary supplements are subject to both adulteration and misbranding provisions. Adulterated products are those that contain unlisted ingredients or are not prepared or packaged under good manufacturing conditions, and misbranded products are those with false or misleading labels. Adulterated or misbranded products and unapproved new drugs are subject to the full range of civil and criminal enforcement measures under the FFDCA and all violations of FFDCA are subject to criminal enforcement at the FDA’s discretion.


What should consumers keep in mind when selecting products?

The consumer needs to be supplement savvy to ensure that a manufacturer is reputable by asking such questions as:

• Has an independent scientific authority verified product purity and quality, providing a third-party seal of approval on the package?
• Has it been tested for the absence of harmful levels of known, potential contaminants?
• Was it produced at a facility that meets or exceeds government and industry standards for good manufacturing practices (GMPs)?
• Does the label make claims that seem too good to be true?
Reputable manufacturers’ websites, such as NatureMade.com, should contain information to answer consumer questions related to the above.