How Dietary Supplements are Regulated

How Dietary Supplements are Regulated

A Timeline of Dietary Supplement Regulation since 1994

1994 The Dietary Supplement Health and Education Act (DSHEA)

• Continues to define dietary supplements as a special Food category; not as food additives 
• Sets new safety standards and FDA authorization to prevent imminent hazards
• Requires manufacturers to follow Good Manufacturing Practices (GMP) set by the FDA
• GMPs were fully implemented between June 2008 and June 2010
• Regulates labels
• All claims must be truthful and not misleading; documentation must be maintained
• All ingredients must be declared on product labels
• Approves pre-existing dietary ingredients already on the market as of October 15, 1994
• Common vitamins, minerals, herbs
• “Grandfathering” was twice applied to pharmaceuticals already on the market:
• The 1938 Food, Drug and Cosmetic Act
• The 1962 Kefauver-Harris Amendment
• This is analogous to pharmaceuticals where all drugs entering the market after 1938 and then after October 10, 1962 require an FDA submission/approval process
• Requires pre-market submission to FDA of all New Dietary Ingredients (NDIs), not products
• The agency questions or rejects the majority of submissions

 1997 The Food and Drug Administration Modernization Act (FDAMA)

•  Provides for health and nutrient content claims based on an authoritative statement by a scientific body of the U.S. government (i.e. NIH) or the National Academy of Sciences
• Such claims may be used only after review of a health claim notification by 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

2004 The Anabolic Steroid Control Act amendment

• Bans steroid precursors sold as dietary supplements
• The FDA and 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 record-keeping of all adverse events (AERs) and reporting of all serious AERs to FDA; for both dietary supplements and OTC drugs

 2007 Food and Drug Administration Amendments Act

• Prohibits interstate commerce of any food, including dietary supplements, containing drugs or medical biologic products approved by FDA as such or clinically investigated as drugs/biologics

2010 The annual report of the American Association of Poison Control Centers

•  Published in the journal Clinical Toxicology
• Reports zero reports of accidental deaths from dietary supplements

2010 Full implementation of mandatory federal cGMPs was completed in June

• All manufacturers & suppliers are now bound by FDA standards of safety and documentation

2010 The FDA Food Safety Modernization Act

• Includes enhanced mandatory recall authority for most foods, including dietary supplements
• Expanded facility registration and HACCP (safety handling) rules
• Requires FDA to issue guidance on New Dietary Ingredients (NDIs), per DSHEA

2011 The FDA released a new Guidance on its enforcement of NDI regulations

• Requires approval of NDIs by the FDA, not just pre-market notification to the agency
• Redefines NDIs as all products containing an NDI ingredient, not just the ingredient itself
• Expands the definition of NDI to include new ingredient processing techniques
• Would encompass tens of thousands of products versus dozens of ingredients earlier projected (1997)

2012 Due to objections from Senate leaders who had co-sponsored DSHEA, FDA notifies Senators Hatch and Harkin that its NDI guidance will be revised & reissued