Manufacturer of Natural Products That Empower People to Lead Healthier Lives
Nutrition for Optimal Wellness
Advocacy
 
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From left to right, Neil Levin - NOW Foods Nutrition Education Manager and Truth Advocate, Al Powers - NOW CEO, Mike Richard - Assistant to the President.
These and others from NOW, including Jim Emme - NOW President and El Richard - NOW Founder and Chairman, have been to Washington or spoken to elected officials on behalf of the Natural Products industry.

 
Your Voice for Health logo
Your Voice For Health is an organization that scans major advocacy news sites to keep you informed about important legislation that could impact your health choices.
 


MISSION ACCOMPLISHED: Dietary Supplements are now Safely Regulated

   
 

 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.

 

This is a select group of grassroots organizations for natural health issues that provide Action Alerts and links to Congressional Representatives:

 

citizens_speak_logo.jpg alliance_nat_health_logo.jpg NPA_logo.jpg

 

Grassroots Tips:

1. Three quick tips for messages to Congress
  a. Make it clear that they are your representative … I vote in your district!
  b. Keep it short, simple, and sweet (be courteous).
  c. Let them see why it’s important to you by telling your story; if using a form letter, tailor it!
2. Building a relationship with your legislators improves access and communication during challenging times.
  More info:   Building a relationship with your elected officials
3. Grassroots guidance from NPA: Your Guide to Effective Grassroots Action (3 MB)

 

 

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For more information about NOW’s advocacy efforts on your behalf, please contact us at Advocacy@nowfoods.com 

(Photo: NOW Truth Advocate Neil Levin with Sen. Tom Harkin, IA)

 

Here are some independent organizations that NOW Foods supports through membership, financial contributions, board of directors’ membership, committee work, and/or the personal efforts of NOW’s employees:

This is a select list of organizations actively advocating for natural health issues:

 alliance_nat_health_logo.jpg Alliance for Natural Health - USA (ANH-USA)
   
 ahpa_logo.gif American Herbal Products Association (AHPA)
   
 anh_logo.gif Alliance for Natural Health - Europe
   
 citizens_speak_logo.jpg Your Voice for Health
   
 NPA_logo.jpg Natural Products Association (NPA)
   
 org_trade_logo.jpg Organic Trade Association (OTA)
   
   

 

This is a select list of scientific organizations supported by NOW Foods that develop information for use by the natural health industry

 

 abc_logo.jpg American Botanical Council (ABC)
   
  American Herbal Pharmacopeia (AHP)
   
 aocs_logo.jpg American Oil Chemists' Society (AOCS)
   
 nhri_logo.jpg Natural Health Research Institute (NHRI)
   
 crn_logo.jpg

Council For Responsible Nutrition