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The myth that the supplement industry is "unregulated" continues to pervade the consumer mindset. Al Powers, president of supplement manufacturer NOW Foods, works to dispel some of that confusion with this brief timeline outlining the passage of the numerous acts, mandates and guidances that round out the regulatory framework governing supplement sales in the United States.
July 5, 2011
2 Min Read
1994: The Dietary Supplement Health and Education Act (DSHEA)
Requires manufacturers to follow Good Manufacturing Practices (GMP) set by the U.S. Food and Drug Administration (FDA)
GMPs fully implemented between June 2008 and June 2010
Continues to define dietary supplements as a special food category
Regulates labels
All claims must be truthful and not misleading
All ingredients must be on the labels
Documentation to prove “structure-function” claims must be maintained
Approves pre-existing dietary ingredients already on the market as of October 15, 1994
Includes common vitamins, minerals, herbs
“Grandfathering” applied twice to pharmaceuticals already on the market: the 1938 Food, Drug and Cosmetic Act & 1962 Kefauver-Harris Amendments
Requires pre-market submission to the FDA of all New Dietary Ingredients (NDIs) marketed after October 15, 1994
The agency questions the majority of submissions
The agency has the power to reject applications, and has done so
The system is analogous to pharmaceuticals, where all drugs entering the market after October 10, 1962 require an FDA submission/approval process
1997: The Food and Drug Administration Modernization Act
Provides for health claims based on an authoritative statement by a scientific body of the U.S. Government or the National Academy of Sciences
Such claims may be used only after submission of a health claim notification to FDA
2002: The Public Health Security and Bioterrorism Preparedness and Response Act
All food manufacturers, including dietary supplement manufacturers, are required to be registered with the government and give advance notification of raw materials imports
2003: The FDA Consumer Health Information for Better Nutrition Initiative
Provides for qualified health claims where the quality and strength of the scientific evidence falls below that required for FDA to issue an authorizing regulation
Such health claims must be qualified to assure accuracy and non-misleading presentation to consumers
2004: The Anabolic Steroid Control Act Amendment
Bans steroid precursors sold as dietary supplements
The FDA and Drug Enforcement Administration (DEA) have authority to take action against adulterated products
2004: The Food Allergen Labeling and Consumer Protection Act
Requires label disclosure of the 8 major allergens that cause 90% of all food allergies
2006: The Dietary Supplement and Nonprescription Drug Consumer Protection Act
Requires reporting of all serious adverse events (AERs) for both dietary supplements and OTC drugs
2010: The most recent annual report of the American Association of Poison Control Centers
Published in the journal Clinical Toxicology
Contains zero reports of accidental deaths from dietary supplements
2010: Full implementation of mandatory federal cGMPs
All manufacturers & suppliers now bound by FDA standards of safety and documentation
2010: The FDA Food Safety Modernization Act
Includes enhanced mandatory recall authority for all foods, including dietary supplements
Expanded facility registration and HACCP rules
Requires FDA to issue guidance on NDIs as per DSHEA
2011: FDA releases new guidance on NDI enforcement under DSHEA
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