My report on regulation of health claims

On April 24, 2010, I was asked as a representative of the American Nutrition Association to participate in a panel discussion at the annual conference in Chicago called Health Journalism 2010, held by the Association of Health Care Journalists. The panelists presented short statements and slides, then answered audience questions. This is a link to my report and slides from that event:

http://americannutritionassociation.org/newsletter/assessing-claims-functional-foods-nutritional-supplements

Dietary Supplements are now Safely Regulated

TIMELINE:

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:

     o  The 1938 Food, Drug and Cosmetic Act & 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 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



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


The Food Allergen Labeling and Consumer Protection Act


• Requires label disclosure of the 8 major allergens that cause 90% of all food allergies



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



     The Food Safety bill

• Includes enhanced mandatory recall authority for all foods, including dietary supplements

• Expected to pass Congress soon

How proteins are digested to liberate amino acids

Digestion is obtained by actions of stomach acid (low pH) and enzymes both in the stomach & intestines (pancreatic protease). In the acidic environment of the stomach, the negatively charged side chains are removed by pepsin. In the more alkaline environment of the intestine, the positively charged side chains are removed by trypsin. In the stomach, Pepsin helps to "unwind" the proteins and breaks the bonds between the amino acids in certain places. In the small intestine other enzymes break the bonds between different amino acids than pepsin does. Because proteins are such complicated molecules it takes a long time and more than one enzyme to completely break them down into amino acids. Digestion results in about 60% small peptides (or peptide bound), which are longer chains of amino acids, and 40% free amino acids (free form). Peptides can be further broken down by hydrolysis in enterocytes (intestinal absorptive cells, simple columnar epithelial cells found in the small intestines and colon).

All proteins are naturally hydrolyzed by stomach acid during normal digestion and the amounts in mineral chelates are in milligram, not gram, strengths. Fermentation to make healthy foods like cheese, vinegar, yogurt, miso, etc. also digests proteins and liberates amino acids, which are of course essential to human nutrition.

Although the excitatory amino acids aspartic acid and glutamic acid are not essential amino acids, the body can create them from numerous sources. In fact, glutamine is the major circulating amino acid and the brain will break down muscles to get it for fuel if the blood sugar is too low to support brain function. Glutamine also fuels some intestinal cells.

Sports Supplements Are Regulated

To the editor (Times Herald-Record, Hudson Valley, New York state):

Your special report, “Supplements for athletes stir serious debate” (June 29, 2010) is interesting but presents some misleading ideas.

For example, the quote that “18.8 percent of supplements are tainted with steroids or other illegal, potentially dangerous ingredients” is seriously flawed, since the percentage actually refers to 240 sports supplements tested, a tiny fraction of the tens of thousands of dietary supplements on the market. These products were actually tested 9 years ago when steroid precursors were legal; spiking them with steroids was always illegal. Today, thanks in part to the dietary supplement industry lobbying for a federal ban on steroid precursors, that product category is dead and this inflammatory quote does not reflect the present market. If any illegal drug is present in a product it is defined by law as an unapproved drug, not a dietary supplement, subject to FDA and DEA enforcement.

Regarding Senator McCain’s bill to more strictly regulate supplements: I met with him after the bill was introduced to present the inconsistencies between the actual bill and how he described it. Under the anti-bioterrorism bill of 2003 all dietary supplement manufacturers are already required to register with the FDA; as do all domestic or foreign food manufacturers selling in the US. Under several federal laws all ingredients already must be on dietary supplement labels. Failure to do so makes the products adulterated and subject to a range of FDA actions. His bill would actually have subjected each new product introduction to prior FDA approval, expanding the federal bureaucracy and amounting to a government takeover of the entire dietary supplement industry. Importing this Canadian-style regulatory scheme would duplicate that system’s failures: half as many products on the Canadian market, products considered safe in the US are effectively banned, waits of over 4 years to introduce variations of existing products, higher prices, etc.

Your series promises to disclose how the dietary supplement industry “is opposed to regulations.” That is absolute nonsense! The dietary supplement industry has long supported new laws and regulations that are reasonable, with these already in place: all vitamin companies must follow FDA-audited Good Manufacturing Practices requiring safety and identity testing, only FDA-approved ingredients can be used, steroid precursors are banned, and companies must disclose all complaints of adverse events requiring medical attention to the FDA within 15 days. The dietary supplement industry supports increased government authority to mandate product recalls in the Food Safety Bill. But the American people won’t stand for a major expansion of government power that gives bureaucrats absolute veto authority over each new consumer product, stifling innovation. That’s not only anti-capitalism, it’s un-American.

Original story
http://www.recordonline.com/apps/pbcs.dll/article?AID=/20100629/SPORTS/6290316/-1/SPORTS

This reply published:
http://www.recordonline.com/apps/pbcs.dll/article?AID=/20100709/OPINION/7090312

Reference:
http://multimedia.olympic.org/pdf/en_report_324.pdf