Thursday, February 21, 2013

Vitamin D Testing & 3rd Party Certification

A letter in a recent medical journal stated that in a recent study the only vitamin D supplement to pass the authors’ potency testing was a USP-verified product.  The authors explicitly endorsed the USP certification program and the brands that utilize this standard. [1] News reports are duly reporting that consumers should only purchase USP-verified Vitamin D. (12) But the data in the study did not justify that conclusion, so those news reports were based on inaccurate information and are therefore wrong.  

The  authors claimed that “the Food and Drug Administration [FDA] does not regulate vitamin D supplements.”  1  This is simply not true.  [2]  The FDA does indeed regulate all dietary supplements, including Vitamin D. 2  A summary of dietary supplement regulation is posted on that agency’s website. [3], 9   There are also various third-party summaries of current dietary supplement regulation available. [4], [5], [6], [7], [8], 10 

The USP-verified OTC standards require a potency of 90% - 110% of the active label claim, as the authors point out.  But this allows levels which are below the minimum required by the Dietary Supplement Health and Education Act of 1994 and the resulting FDA current Good Manufacturing Practices (cGMPs) that regulate supplement manufacturing and labels.  The federal cGMPs require greater or equal to 100% potency; the capsules must at least match the label claims.  This means that a product tested at 99% potency would be acceptable by the USP standards, but would not meet the FDA cGMP standards set in the regulations governing dietary supplements.  This also means that a USP-Verified product could actually be deemed “misbranded” under these regulatory standards, and therefore illegal. So you can quickly see that the USP’s OTC (over the counter) drug standard is not applicable to dietary supplements. 10  

In the letter published in that medical journal the authors reported that four of the 12 brands tested had samples that met the authors’ standards as being within their stated acceptable range of variance from label claim, yet only one of these was from a USP-verified company. Why was that brand singled out as superior when at least 3 other brands were within those same chosen (and as we discussed already, unacceptable) limits? And why did the authors specifically endorse that brand‘s certification program when admittedly one of the two USP-verified brand’s products tested actually failed this testing? 1  That’s a 50% failure rate, and the one USP-verified product that didn’t fail that standard still did not reliably meet the cGMP legal standard.  To me, an experienced science writer, these inconsistencies of logic suggest a bias against the non-USP-verified brands and an unjustified conclusion that conveniently met the authors’ preconceived notions of dietary supplements being ‘unregulated’.  

In this study, only 5 brands are USP-verified (Berkley & Jensen, Kirkland, Nature Made, Sunmark, TruNature).  All are sold in mass market (Albertsons, BJ’s Wholesale Club, Costco, CVS, Eckerd, Giant, Health Mart, Hy-Vee, K-Mart, Kroger, Long’s, Osco Drug, Ralph’s, Rite-Aid, Safeway, Sam’s Club, Stater Bros, Super Valu, Target, Valu-Rite, Walgreen’s), not health food stores. [9] Brands sold in the natural products channel (health food stores) typically don’t verify their products to the non-compliant USP standards. Most good natural products brands are certified by different 3rd party organizations that certify their compliance to the FDA’s cGMP standards, which are the law of this land.  [10], [11] We don’t know if any of the brands tested were third-party certified by these other organizations because the authors did not disclose those brands or discuss any other claims of third-party certification. 1  

Why do people buy vitamins at health food stores instead of drug stores in the first place?  Many people reject some of the pharmaceutical ingredients that are commonly used in products sold in that channel but which are not used in vitamin products sold in the natural channel.  These questionable ingredients include petroleum and coal tar derivatives, talc, hydrogenated oil, artificial colors/flavors/sweeteners, crospovidone, butylated hydroxytoluene, and hypromellose.

The moral of this story is “don’t accept everything you read,” even if published by well-credentialed scientists in a “prestigious” scientific journal and dutifully reported by well-meaning news organizations.  Under U.S. law, USP-Verified is not an acceptable standard for dietary supplements because its standard fails to meet the legal requirements for dietary supplements.  Instead, look for dietary supplements that are third-party GMP-certified in order to assure that your vitamins are manufactured under proper conditions to assure safety and efficacy, and are properly tested to meet 100% of label potency as required by law.  

Monday, February 18, 2013

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