An Unregulated Industry?  Really?

It remains to be seen if Attorney General Schneiderman’s testing methods on a handful of herbal supplements are accurate.  The fact that the “expert” who performed the testing for the New York AG (NYAG) has far more expertise testing skinks than supplements should at least raise some eyebrows.  Regardless of the outcome of these random tests, the damage inflicted on our industry is already done, because, once again, the message to consumers is that supplements need more regulations to be safe.  That’s the perception being perpetrated by the press and others.  The reality is quite different.  Like every industry, there are some bad players out there.  We also know that they are a tiny minority.  The truth is something much different. The dietary supplement industry is one of the MOST REGULATED businesses in the United States.So what can we do about this obvious misrepresentation of our industry?We are asking that our retailer members and suppliers reach out to your customers and the local media and get the list below in their hands.  It’s time to fight back with the truth and hard facts.


 A Time-line of Dietary Supplement Regulation since 1994
1994 The Dietary Supplement Health and Education Act (DSHEA)
• Requires manufacturers to follow Good Manufacturing Practices (GMP) set by the FDA
o  GMPs were fully implemented between June 2008 and June 2010
• Continues to define dietary supplements as Food
• Regulates labels
o  All claims must be truthful and not misleading
o  All ingredients must be on the labels
o  Documentation to prove claims must be maintained
• Approves pre-existing dietary ingredients already on the market as of October 15, 1994
o  Common vitamins, minerals, herbs
o  “Grandfathering” was twice applied to pharmaceuticals already on the market:
(1) The 1938 Food, Drug and Cosmetic Act   (2) The 1962 Kefauver-Harris Amendments
• Requires pre-market submission to the FDA of all New Dietary Ingredients marketed after October 15, 1994
o  The agency questions the majority of submissions
o  The agency has the power to reject applications; and has done so
o  This 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 (FDAMA)
• 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
o 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
o The FDA and DEA have authority to take action against adulterated products
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
• Reports zero reports of accidental deaths from dietary supplements
Full implementation of mandatory federal cGMPs was completed in June
• All manufacturers & suppliers are now bound by FDA standards of safety and documentation
The Dietary Supplement Full Implementation and Enforcement Act
• Introduced in Congress to increase funding for FDA enforcement of dietary supplement laws
2011 The Food Safety Modernization Act.
• This bill passed and was signed into law in January 2011. It is supposed to prevent food-borne illnesses and expands the role of the FDA in auditing farms and greenhouse operations. The FDA will hire between 4,000 and 6,000 new inspectors every year from now through 2016. Any violation found (regardless of how technical) will require re-inspection at the owner’s expense. By statute, all of the fees must be dedicated to inspections, thus creating an incentive for re-inspections. This will impose unreasonable costs on small producers and will likely reduce the number. This bill had a clause that required the FDA to publish the New Dietary Ingredient Draft Guidance within 180 days (see below).
New Dietary Ingredient (NDI) Draft Guidance – FDA issued July 2011
• This 47-page document indicated a shift from FDA’s prior interpretation of law that FDA now expects the dietary supplement industry to submit NDI notifications for every supplement containing an NDI. The agency has changed “ingredient” to “product” and has indicated that there are over 55,000 new products on the market since the passing of DSHEA in 1994 which do not have NDI submissions. The FDA’s new interpretation of law results in their being the de facto pre-market approval authority; this was never the Congressional intent of DSHEA. Although not yet law, this document is certainly problematic.



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