When to take products with enteric coating

The reason why we suggest taking enterically coated supplements on an empty stomach is to avoid the pill (capsule or tablet) being trapped in the stomach with food for an hour or more, which could allow the contents to release prematurely prior to reaching the small intestine.

In a study of 24 subjects, at baseline the median gastric pH was ∼1, increased to pH 4.5 with ingestion of the meal, and then returned to approximately pH 1 some 3–4 h after the start of the meal. https://journals.physiology.org/doi/full/10.1152/japplphysiol.00956.2001#:~:text=test%20(nonparametric).-,RESULTS,the%20start%20of%20the%20meal

However, if someone has low stomach acid (aging, antacids, etc.) to start, the pH can increase even more and risk the capsule emptying directly into the stomach. That can cause either degradation of the contents or increased risk of burping up and tasting any oils in the product. 

The esophagus and stomach are especially sensitive to essential oils, as evidenced by people adding drops to water and drinking that, later ending up with mucous lining degradation leading to stomach pain or heartburn, and occasionally emergency room visits.

Stearic acid and Magnesium Stearate update

How much stearic acid is in chocolate? 

We were looking at a chocolate bar yesterday. Dark chocolate is supposed to be a health food. 

As we happened to be nutritionists, the topic of the chocolate bar's stearic acid content came up, which is a controversial fatty acid. So I did a little calculating...

The bar in question is a 72% Dark Chocolate from Belgium, with the fat coming almost exclusively from cocoa butter (except a tiny bit of lecithin; but typically under half a percent is used in chocolate manufacturing, according to Chocolate University Online). The bar weighs 1.65 oz (47 grams), contains 280 calories, and is labeled as being one serving.  

The product label says that the bar supplies 19 grams of fat, including 12 grams of saturated fat. Since about one-third of cocoa butter’s fat - and over half of its saturated fat - is known to be stearic acid, a one-bar serving of this chocolate conservatively can be assumed to contain at least 6 grams of stearic acid, which is equivalent to 6,000 milligrams (mg.). 

How does that compare to the amount of stearates commonly found in tablets and capsules?

That amount in the single small chocolate bar is equivalent to more than 1,000 tablets or capsules worth of stearate content, assuming the highest likely amount of stearic acid or magnesium stearate was used in those pills. Five milligrams is the highest I've seen on supplement Master Formulas, but many products use less or none. (Assuming 5 mg. per pill x 1,000 pills = 5,000 mg. of stearates per bottle).

So if someone had a jumbo, family-sized bottle of a thousand pills, each containing a few milligrams of stearic acid or magnesium stearate that's primarily stearic acid, that whole bottle would contain less stearic acid than a single serving 47 gram dark chocolate bar. 

Doesn't that put stearic acid consumption into perspective? Each pill contains less than 1% of what you'd get in a serving of chocolate. 

How much stearic acid is found in other common foods?

Butter contains about 12% stearic acid, by weight, as do the average beef, pork, or lamb product. Healthy olive and coconut oils contain between 2-3% stearic acid. Salmon oil naturally contains about 4% stearic acid. 

More fun facts:

• Milligrams (mg.) are thousands of a gram; micrograms (mcg.) are millionths of a gram.
• Stearic acid tends to be converted into oleic acid in the liver.
• Stearic acid is abundant in the food supply as a natural component of the fat in those foods; milk and meat fats are the primary sources. 

How much magnesium is in magnesium stearate?

The molecular weight of stearic acid (Octadecanoic acid) is 284.484 grams/mol. There are 2 stearic acid molecules in one molecule of magnesium stearate, which has a molecular weight of 591.257 grams/mol. The molecular weight of magnesium is about 24.305 grams/mol. So the amount of magnesium in a 5 mg portion of magnesium stearate is about 200 micrograms (not milligrams); about half of one one-thousandth (half of 1/1,000 or 0.0005 or 0.050%) of the 400 milligram RDA. That's also 1/20th of a percent of the RDA. 

So the amount of magesium in a pill containing magnesium stearate is negligible; it would be insignificant unless another magnesium source is added. Magnesium stearate is a form of chelated magnesium that contains only about 4% elemental magnesium by weight and about 96% stearic acid.

REFERENCES:

• Kelly FD, Sinclair AJ, Mann NJ, Turner AH, Abedin L, Li D. A stearic acid-rich diet improves thrombogenic and atherogenic risk factor profiles in healthy males. Eur J Clin Nutr. 2001 Feb;55(2):88-96. PubMed PMID: 11305631.
• https://pubchem.ncbi.nlm.nih.gov/compound/5281
• https://pubchem.ncbi.nlm.nih.gov/compound/magnesium_stearate
• https://pubchem.ncbi.nlm.nih.gov/compound/5462224
• http://www.chocolateuniversityonline.com/lecithin-in-chocolate/ 
• https://www.scientificamerican.com/article/why-is-dark-chocolate-good-for-you-thank-your-microbes/
• http://www.cnn.com/2017/10/06/health/dark-chocolate-healthy-food-drayer/index.html
• https://www.nowfoods.com/now/nowledge/stearic-acid-and-magnesium-stearate
• https://epi.grants.cancer.gov/diet/foodsources/sat_fat/sa.html
• http://honestnutrition.blogspot.com/2008/04/myths-about-stearate-risks.html 
• http://spo.nmfs.noaa.gov/Circulars/CIRC276.pdf

John Oliver's take on "Unregulated" Dietary Supplements

Another salvo in the War on Vitamins and Dietary Supplements:

John Oliver was funny, but not remotely fair or accurate. Some of the more grievous false examples (in my opinion):

• He assumed no new laws or regulations have been implemented since DSHEA (the Dietary Supplement Health & Education Act of 1994)
o Untrue, and some have been championed by industry; some examples:
 The 2002 Anti-Bioterrorism law's food safety regulations
 The implementation of mandatory Good Manufacturing Practices regulations and increasing numbers of FDA audits over the past 4 years
 Bans on steroids and their precursors
 A mandatory Adverse Event Reporting law
 The more recent Food Safety Law

• He showed old news reports speculating that the botanical ephedra killed 155 people, asserting that these deaths occurred because of DSHEA tying FDA’s hands
o FDA was admittedly unable to substantiate any deaths
o FDA was able to ban ephedra under DSHEA anyway based on a solely theoretical one death per year from billions of doses taken, despite two FDA expert panels unable to validate any deaths

• He claimed that FDA and FTC are powerless to act because of DSHEA, Hatch and Harkin
o The number of enforcements have been rapidly increasing
 Warning letters, recalls, even seizures
o The number of FDA inspections has been rapidly increasing

• He showed how many citizens supported DSHEA in 1993-1994, but asserted that they were misled by industry champions Senators Hatch and Harkin, who received donations from the then relatively tiny $2 billion industry
o He implied that Hatch and Harkin did it solely for the money
o He implied that Hatch and Harkin still block all regulation; see above for contrary examples
 some of the more recent laws were supported by industry and even sponsored by Hatch and/or Harkin)

• He assumed that dietary supplements are largely unregulated because of not enough regulation, rather than their relatively good safety record versus drugs or even other foods
o He promoted pre-market approval of products and claims, similar to a failed Canadian strategy that cut product selection without enhancing safety
o He cited DNA testing of botanicals failing 1/3 of products tested, without mentioning that this is actually a proposed but not yet validated assay technology disputed by herbal authorities as far too premature to use as a standard

This does not address his criticisms of Dr. Oz, who can defend himself.

Link to show:
http://theweek.com/speedreads/index/263585/speedreads-john-oliver-steps-on-dr-oz-to-savagely-trample-the-dietary-supplement-industry

Most vitamin studies are flawed by poor methodology

In a new published analysis, researchers at the Linus Pauling Institute of Oregon State University report that many large clinical trials of vitamin supplements, especially antioxidants like vitamin C, have flawed methodologies that make them 'useless' in determining the real value of such nutrients.

It is on the basis of such flawed studies created by researchers that are uninformed as to the nature of nutrients that their studies may conclude that vitamins are of no value or may even be harmful.

Of course, common sense tells us that essential nutrients cannot be inherently useless or harmful in reasonable doses, but those are messages that we repeatedly hear in the media reports.  Such flawed science leads to the equally flawed calls for vitamins to be regulated as drugs, adding a new logical error in failing to consider the vast difference in safety between nutrients and drugs.

Drugs are typically synthetic, isolated substances that are foreign to the body and don't act like nutrients, and it is this foreignness of drug properties that make them inherently toxic to the body. That toxicity is the legal basis of regulating drugs as controlled substances, and the failure to demonstrate toxicity of nutrients, except in studies with such flawed methodogies as we are discussing, makes calls to regulate vitamins as drugs hollow and illogical.

A report on that article:
http://www.nutraingredients.com/Research/Most-vitamin-studies-are-flawed-by-poor-methodology-say-Linus-Pauling-researchers

The original peer-reviewed publication in a peer-reviewed nutrition journal:
http://www.mdpi.com/2072-6643/5/12/5161

Supplements vs. Food to Obtain Key Nutrients

Supplements vs Food [Infographic] by the team at Supplement Centre

Sufficient Regulation of Supplements

Critics claim that dietary supplements are under-regulated, which is arguably inaccurate. Critics suggest that the FDA should have the power to ban synthetic analogues of botanical ingredients even when there is no credible safety issue, a major expansion of government authority. There are disturbing attempts to expand the role of unelected government bureaucrats as censors of nature-identical ingredients, even those with a history of safe use.

The FDA recently reinterpreted a 1994 law requiring pre-market notification of New Dietary Ingredients (NDI) unknown to the marketplace or our food supply. The law grants it authority over novel ingredients, not products, by requiring notification, rather than pre-approval. Now the agency is promoting a radical vision by prematurely enforcing its widely criticized Revised NDI Guidance that violates the letter and spirit of the law. FDA asserts the unilateral power to change from requiring pre-market notification of a new ingredient to a de facto registration giving it virtual veto power over all products containing that ingredient. Under its new interpretation, any change of processing or source (i.e. synthetic botanical) gives the FDA power to reject an ingredient even when indistinguishable from one in the food chain.

FDA lacks not only legal authority, but resources to screen thousands of products explicitly regulated as a food category with a presumption of safety. The FDA rejects most pre-market notifications of new ingredients; slowing introduction of new dietary supplements to the marketplace.

Industry critics ignore how dietary supplement regulation has evolved. Mandatory Good Manufacturing Practices (GMPs) are being vigorously audited/enforced by FDA, requiring identity, potency, and safety testing plus rigorous procedure documentation. All serious adverse events must be reported to the FDA within 15 business days. GMP audits and NDI notifications represent pre-market monitoring; AERs post-market surveillance. The Food Safety Bill enhanced FDA’s recall authority. This regulatory regime is so successful that for years there have been no deaths from dietary supplements reported to Poison Control Centers. Current laws work. We don’t need a virtual government takeover of the dietary supplement industry under the pretense of safety.

Thyroid supplements

People typically seek thyroid support nutrients as a way to enhance their energy levels, enable proper control of their body temperature, and support a strong metabolic rate.  We take these nutrients, both individually and in formulas, in order to assure adequate levels to support optimal thyroid function, since a deficiency or insufficiency of key nutrients could reduce the operational efficiency of the thyroid gland.   Proper thyroid function supports a lean body composition and helps prevent fatigue.  Under the control of complex feedback and signals from the hypothalamic-pituitary-thyroid axis, the thyroid gland regulates body temperature and metabolism rates, playing an important role in weight management and energy states.  By the same token, if any of the important nutrients are not available to the thyroid in sufficient amounts, metabolic rates and energy levels could suffer. ¹

Natural thyroid support supplements work primarily by providing precursors of thyroid hormones, along with various cofactors, in order to encourage proper thyroid function.  In some cases, the lack of adequate nutritional resources prevent the thyroid gland from maintaining optimal efficiencies, and if the gland can’t maintain healthy levels of its important hormones, then it can’t adequately support the body’s metabolism.  Unlike medical treatments, nutritional approaches focus on providing what the body needs in order to assure that the thyroid has its particular needs met and can function optimally. 

The key nutrients for thyroid function are the mineral Iodine and the natural amino acid L-Tyrosine. 

Humans require iodine for cellular metabolism and for normal thyroid function; specifically for the production of thyroid hormones.  Thyroid hormones regulate many important biochemical reactions, including protein synthesis and enzymatic activity, and are critical determinants of metabolic activity.  Iodine is a nutrient that can sometimes be obtained from the soil, but many soils are deficient.  Areas that are mountainous, very rainy, or prone to floods/erosion tend to have soils that are low in iodine, increasing the risk that foods grown in those areas will be iodine-deficient.  Table salt is commonly iodized, but those using non-iodized salt or on low-sodium diets can’t rely on that source.  Multivitamin formulas, thyroid support formulas, kelp and some other seaweeds, and some multimineral formulas provide supplemental iodine.  The U.S. Recommended Dietary Allowance (RDA) is 150 mcg (micrograms) daily for adults ages 18 and older, 220 mcg daily for pregnant women, and 290 mcg daily for lactating women. The Tolerable Upper Intake Levels (UL) for adults ages 18 and older is 1,100 micrograms daily. ^{2-3 ]}

The common sources of iodine in dietary supplements include Potassium Iodide, Kelp, and other seaweeds.  While kelp and some seaweeds are fine for getting the relatively low RDA level of iodine intake, those seeking much higher levels are usually advised to consider Potassium Iodide.  This is because seaweeds typically contain less than 1% iodine, along with a lot of other metals and minerals - including some that we may want to avoid getting too much of - so consuming high doses of seaweeds on a daily basis may not be our safest option.  And iodine is a mineral nutrient that needs to be replenished daily.

L-Tyrosine is an amino acid that is important to the structure of most proteins in the body. It is also the precursor of a number of neurotransmitters and hormones, including the major catecholamines dopamine, norepinephrine, and epinephrine (adrenaline), which are stress hormones made by the adrenal glands.  In addition to these functions, tyrosine also helps produce melanin (the pigment responsible for hair and skin color) and helps in the function of the adrenal, thyroid, and pituitary glands.  Because of these varied responsibilities and the ability of various stresses and dietary deficiencies to reduce tyrosine levels, people sometimes supplement tyrosine (as natural L-Tyrosine) in order to support proper thyroid function. ^4-5   

How do Iodine and L-Tyrosine affect thyroid function?  The thyroid gland’s epithelial cells prepare large quantities of tyrosine into a glycoprotein “scaffold” that is the structural backbone used to form the thyroid hormones thyroxine (T4) and triiodothyronine (T3).  The scaffold and iodine are both secreted into the lumen of the thyroid gland, where an enzyme facilitates the hormone synthesis.  Other enzymes then separate the hormones from the scaffolding in steps, liberating them into their circulating forms.  A few tyrosines are incorporated into these hormones, but most are left in the scaffolding structure’s remains that will be recycled by the body. 

Selenium is an essential mineral nutrient that is necessary for normal thyroid hormone metabolism.  Selenium-containing enzymes control the synthesis and degradation of the biologically active thyroid hormone, T3.  Selenium deficiency may worsen the effects of iodine deficiency on thyroid function, and adequate selenium nutritional status may help protect against some of the neurological effects of iodine deficiency.   Additionally, selenium-based antioxidant enzymes protect the thyroid gland from peroxides produced during the synthesis of these hormones. ^{2, 3, 6}

Zinc, another essential mineral responsible for hundreds of critical chemical reactions in the healthy human, is also important for maintaining normal thyroid homeostasis. Its complex roles include effects on both the synthesis and mode of action of the hormones.  Thyroid hormone binding transcription factors, which are essential for modulating gene expression, contain zinc bound to cysteine-related compounds.   In some studies, low zinc status was associated with decreased thyroid hormone levels.  ³

Copper is believed to have a role in thyroid hormone function, perhaps related to selenium status. ³

Guggul (Commiphora mukul) is an Indian Ayurvedic herb that contains the active compound Guggulsterone, which has been shown to stimulate thyroid activity. ^7-8

 
These ingredients, both singly and as thyroid support formulas, are in demand by consumers wanting to assure adequate thyroid function in times of dietary insufficiencies and various stresses.  Of course, these nutrients and their many functions in the body have a host of potential benefits to those supplementing with them if they may not get adequate amounts from their diet for their individual requirements. 

 

REFERENCES

---

1.  Zoeller RT, Tan SW, Tyl RW. General background on the hypothalamic-pituitary-thyroid (HPT) axis. Crit Rev Toxicol. 2007 Jan-Feb;37(1-2):11-53. Review. PubMed PMID: 17364704.
2. http://ods.od.nih.gov/factsheets/Iodine-HealthProfessional/
3. Arthur JR, Beckett GJ. Thyroid function. Br Med Bull. 1999;55(3):658-68. Review. PubMed PMID: 10746354.
4. http://www.umm.edu/altmed/articles/tyrosine-000329.htm
5. http://www.vivo.colostate.edu/hbooks/pathphys/endocrine/thyroid/synthesis.html
6. http://ods.od.nih.gov/factsheets/selenium/
7. http://www.drugs.com/npp/guggul.html
8. http://www.peoplespharmacy.com/2005/10/18/guggul/

NYT Hatchet Job on Senator Hatch

Re: “Support Is Mutual for Senator and Utah Industry” (The Champions, June 20, New York Times)

The article presented an inaccurate impression regarding the nutritional supplement industry. Despite heavy costs, manufacturers supported federal regulations creating more rules/enforcement to enhance accountability and public safety. A 1994 law (DSHEA) regulating the dietary supplement industry allows only FDA-approved ingredients and scientifically-supported claims relating to healthy body structures and functions; besides FDA-approved claims.

Additional regulations supported by industry: DSHEA’s mandatory Good Manufacturing Practices (GMP) requiring safety and identity testing, steroids and their precursors are banned; manufacturers must promptly disclose adverse events requiring medical attention; mandatory safety recall authority.  

Senator McCain’s proposed dietary supplement regulation would have subjected each new product introduction to prior FDA approval, expanding the federal bureaucracy with a government takeover of the industry. Importing this Canadian-style regulatory scheme would duplicate that system’s failures: half as many products available; some considered safe in the USA are banned; long waits for variations of existing products; higher prices.

Fortunately, the American people rejected giving government bureaucrats veto authority over all new nutritional products, which already must use preapproved ingredients. We view this as anti-capitalism and un-American.

Neil E. Levin, CCN, DANLA

Clinical Nutritionist

HonestNutrition.com

re:

http://www.nytimes.com/2011/06/21/us/politics/21hatch.html?_r=2&pagewanted=all

ADULT WEIGHT MANAGEMENT interview, Vitamin Retailer magazine, February, 2011

Weight management products have long been an important category for natural product retailers, partially because it is such a problem for many people to control their weight but also since many people shop in these stores because they want to use natural products that are free of potentially risky pharmaceuticals. As a gateway category for transitional shoppers that may be new to health food stores, weight management products become an important gauge of a commitment to meeting these people’s needs and thus keeping them as customers willing to try other products. Of course, nutritionists will suggest a comprehensive diet and supplement plan, rather than relying on “magic bullet” single products.

Good Manufacturing Practices (GMP) regulations have gone into effect over the past several years, raising the bar on manufacturers’ quality control practices. At the same time, mandatory Adverse Event Reporting (AER) was also implemented. Both of these regulatory mechanisms should increase consumer confidence and belie the myth that the industry is “unregulated”.

I believe that the glut of stories about Americans being overweight tends to make people more aware of their own lack of exercise and dietary restraint, which contribute to their excess weight. Of course, health scares and medical crises also alert people to their mortality and tend to motivate healthy dietary and other lifestyle changes. Today’s youth-obsessed media makes people want to look young and fit even past middle age. Plastic surgery, being expensive and with some risks, is far from a perfect solution. There are no shortcuts to health, only natural aids to good health. The very visible failures of both diet drugs and illegal products pretending to be dietary supplements illustrate the depth of the market and the need for effective natural weight management products.

Consumers tend to look for something that was recommended to them, either by a person or an authority. The person could be a family member, co-worker, or an acquaintance. The authority could be someone cited in the media, on the Internet, or a trusted trainer or health professional. Top categories are controlling appetite (satiety), increasing metabolism (thermogenics), and blocking the absorption of certain food components such as carbohydrates or fats (nutrient blockers).

Natural foods and fibers are part of the solution to maintaining healthy weight and blood sugar. These foods would include whole grains as well as fibers from various sources. Some of these fibers are gluten-free and/or organic, such as Flax, Acacia, Inulin, and Psyllium. Fibers also help satiety, the feeling of being full.

Consumers today are more concerned about the quality and safety of diet support products, so are looking for assurances of adequate quality controls and testing. Some parts of this process include method validation and development, stability testing, identity testing, microbiological testing, heavy metal testing, specification development, overseeing production, procuring samples and preparing them for testing, and even raw material vendor audits.

Nutrients for Bone and Joint Health Interview

This interview was given to Whole Foods Magazine, excerpts were published in the February 2011 issue:

Despite evidence in recent medical journals, including several review studies calling for a far higher RDA and UL (upper limit) that would be five times the previous levels, the IOM held true to its conservative bent and raised the RDA and the UL; but only by 50% by only 100%, respectively . Observers are somewhat disappointed, but not really surprised. The most controversial part of the IOM committee’s report is that the only proven role for vitamin D is in bone and calcium metabolism, combined with its finding that most Americans already get enough for those benefits. That should come as news to researchers from Mayo Clinic operating under an NIH grant who recently reported that “Vitamin D insufficiency is common globally and in the United States. Approximately 25-50% of patients seen in routine clinical practice have vitamin D levels below the optimal range…” It also should be news to European regulators that recognize vitamin D’s beneficial effects on muscles, immunity, inflammation, cellular health, and reproduction. We recognize the new increased recommendations for vitamin D and the new higher safety recommendation, but believe that these numbers are insufficient to support vitamin D’s roles that go beyond calcium and bone health.

The need for joint and bone health nutrients in general increases with age. Aging also tends to reduce absorption of nutrients, forcing us to take higher amounts and better forms in order to assure adequate nutrition. The tendency of many seniors to cut back on meals, for reasons such as loss of taste or smell or interest in cooking, may also increase the need for supplementation of essential nutrients. The major joint and bone problems increase with age, and studies have shown the ability of relevant nutrients to maintain healthy bone and joint structures during these vulnerable times of life. Older customers that are more likely to take calcium supplements also tend to have diminished stomach acid available for digesting calcium from food and non-chelated (predigested) forms, so tend to do better with the predigested forms. These include calcium as citrate, malate, ascorbate, or bonded to specific amino acids; all are weak acidic sources that form a stable bond with the alkaline calcium and the resulting compound simulates the calcium complexes formed naturally during proper digestion.

While calcium and vitamin D are known for their role in bone and calcium metabolism, there are other nutrients necessary for bone health. These include silica, boron, magnesium, vitamins C and K, etc. protein. Comprehensive bone formulas include over a dozen nutrients, which are also available singly.

Children need to get sunshine, exercise, and a variety of calcium from food sources to ensure the body’s needs for bone health. If the child does not eat ample amounts milk and dark green leafy vegetables, they may need to complement the diet with appropriate dietary supplements.

Adults need to take care of their bodies and not impact the joints too much with hard exercises or excess weight. Support the joints nutritionally with glucosamine, vitamin C, a good multivitamin, and natural substances that modulate inflammation.

One should not neglect the long-term benefits of glucosamine to maintain joint distances that may otherwise erode, for example, while seeking fast-term temporary relief of aches and pains. By providing those products in both categories as well as overlapping combination products, we can supply a more holistic and sustainable nutritional joint support program.

Many of the Joint Structural Support Products contain varying amounts of glucosamine and/or chondroitin, as well as MSM, Hyaluronic Acid, and other well-known ingredients.

NHRI Symposium on Cost-Effectiveness & Safety of Dietary Supplements

The NHRI (Natural Health Research Institute) is a non-profit institute dedicated to research in natural cost effective dietary supplements and natural products.


NHRI will be hosting a scientific symposium in November in the local area. Click on this link for more details:


NHRI symposium announcement

We hope that this symposium "Natural Products – Cost-Effectiveness & Safety of Dietary Supplements" will help boost awareness of the safety and cost effectiveness of dietary supplements and natural products.

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

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

Vitamins Are FDA-Regulated

Contrary to popular myth and The Healthy Skeptic (LA Times 3/1/10), the federal FDA (Food and Drug Administration) already regulates dietary supplements such as vitamins, minerals and herbs. These are NOT “unregulated” products. What actually makes critics’ teeth grind is the fact that vitamin formulas do not need specific pre-approval from the federal regulators, which is the true endgame of many skeptics. But all ingredients used in nutritional supplements before mid-October of 1994 are already pre-approved by the FDA under an often-misrepresented law called DSHEA, which also requires all new dietary ingredients to be submitted to the FDA for pre-market review before a product is sold. This gives the agency a chance to review the required submission of safety and efficacy data before any new ingredient can be sold, and the power to veto its introduction.

Dietary supplement manufacturers are already required to submit label claims along with scientific documentation to the FDA, but are paradoxically required to use a label disclaimer that the agency has not evaluated the formula. Vitamin makers are already registered with the government, are already prohibited from making medical/drug claims for dietary supplements, and are already required to identity-test and list all ingredients on product labels. A recent adverse event reporting law promptly lets the FDA know of virtually any problem requiring medical attention in order to trigger recalls and new label warnings. Under DSHEA, the FDA can regulate the manufacture of all dietary supplements, an oversight that was dramatically improved over the past 3 years with the rollout of mandatory Good Manufacturing Practices. Obviously, this is not an “unregulated” industry, even if enforcement can be improved in some areas.

Advocates of pre-approval of dietary supplement formulas want to import a highly flawed and controversial Canadian health care program in a misguided effort to give our own unelected government bureaucrats absolute power over already-regulated vitamin products. Many Canadians now cross the border to buy American supplements because their own government arbitrarily delays entry of new products for years at a time, miserly approving only 42% of products that have been submitted with all of the required safety and efficacy documentation. This is not a free market model, does not work well, and is not worth copying.

A permanent government takeover will strangle a preventive health industry that, in America’s free market, has added jobs and exports during our recent recession. Vitamins help Americans meet basic nutritional needs in a cost-effective manner without government funding; and probably decreased some Medicare spending, according to the conclusions of authoritative Lewin Group reports. There is a complex regulatory structure for vitamins and other dietary supplements in the U.S. that is working quite well; there were ZERO deaths officially reported from these products last year even though about 2/3 of Americans use them. Claims that “vitamins are unregulated” are woefully inaccurate and should not be published by news outlets with competent fact checkers.

http://www.latimes.com/features/health/la-he-0301-skeptic-20100301,0,2486837.story

Boston Globe wrong on Vitamins, Supplements

Dietary Supplements Are Regulated In its Nov. 2 editorial, the Globe complained that the FDA is “powerless” to police dietary supplements and called for a repeal of the Dietary Supplement Health and Education Act of 1994. Health and Education Act of 1994. I suggest that the editors read the law and see what it is that they would lose by doing so. Mandatory Good Manufacturing Practices (GMP) were authorized by this law. GMPs control the manufacturing of all supplements, requiring quality controls, identity and safety testing. Federal GMPs are currently being implemented. No one in their right mind wants this to go away right when it is just getting started. Federal pre-approval of all new dietary ingredients (NDIs) is also required by DSHEA. Isn’t that close to what the editors suggest when they want pre-market approval of all new supplements? Adulterated products are already banned by this law. And steroids and steroid precursors are specifically banned under another more recent law that was supported by the dietary supplement industry. DSHEA bans misbranded products, such as those containing hidden drugs, and offers them absolutely no protection. In fact, the misbranded products that the editors complained about are actually defined as unlabeled drugs by the FDA, not as dietary supplements, so technically DSHEA does not even apply to them. Let’s leave out the evildoers who deliberately hide illegal drugs in bottles misbranded as dietary supplements. What does that leave us with? The vast majority of dietary supplement companies responsibly follow the law and do not have poor quality products. There are rarely cases of serious injuries or deaths from dietary supplements when you take away the products that are really illegal drugs made by outlaws who don’t care about the law or their own customers’ health. Responsible brands follow the new FDA dietary supplement GMPs, checking all ingredients for identity and purity and looking for contaminants and known adulterants. They truthfully declare all ingredients and correct dosages on the labels. They monitor product usage for adverse events and report serious ones to the FDA when they occur. They are not the criminals counterfeiting illegal drugs disguised as dietary supplements. What part of this cries out for such severe regulation that pre-market approval of new formulas is needed? How will new laws stop lawbreakers when their actions are already clearly illegal? Pre-market approval in Canada is a joke; many ingredients and formulas are not available there even though American citizens freely enjoy their use without serious issues. Some American manufacturers have already pulled out of the Canadian market, while others offer only small selections of their lines because of the bureaucratic hoop jumping required for government approval. If DSHEA is repealed, many safe legal products providing much-needed nutrients will disappear while the lawbreakers continue to do business, with a net harm to public health. http://www.boston.com/bostonglobe/editorial_opinion/editorials/articles/2009/11/02/police_these_pills_and_powders/

Mislabeled Vegan Supplements?

It appears that some vitamin brands are listing their products as Vegan, yet formulating them with vitamin D3 synthesized from Sheep's Lanolin. There is no Vegan source of vitamin D3, which is produced by chemical synthesis when animal fats called sterols are exposed to Ultraviolet light (UVB rays). D3, or cholecalciferol, is always made from animal fat. The other form, vitamin D2, or ergocalciferol, is from a Vegan source; though one has to watch out for animal gelatin stabilizers and microbeads in microencapsulated dry forms, especially. Vegan microencapsulation for dry forms of fat-soluble nutrients including beta-carotene and lutein was only perfected in mid-2005, so it is possible that some products made before then were mislabeled as Vegetarian if the company did not investigate its raw material sources carefully. (Many brands do not manufacture their own vitamin supplements, relying on contract manufacturers to make their outsourced formulas for them. In many cases, the brands do not normally have access to the full ingredient and finished product specifications of the actual manufacturer. This can lead to ignorance and errors when making label claims related to the presence or absence of allergens and animal products.) The D2 form is synthesized from plant sterols exposed to the same kind of light. Plant sterols, by the way, have an FDA-approved health claim that they "may reduce the risk of heart disease" and are considered healthy. http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodLabelingNutrition/FoodLabelingGuide/ucm064919.htm There is also a controversy over whether D3 is much better than D2. D3 is the form found in fish liver oils and is often added to fortify foods such as milk and orange juice. D3 is also the form that we synthesize in our own bodies when cholesterol (that animal sterol aforementioned) is exposed to UVB rays. D2 is likewise made by plants when their oils (plant sterols, or phytosterols) are exposed to UVB light. In modern studies, both forms are equally well absorbed and both are good at preventing rickets and maintaining bone mass. Both forms equally maintain the level of the active compound serum 25(OH)D3 levels. "Therefore, vitamin D2 is equally as effective as vitamin D3 in maintaining 25-hydroxyvitamin D status." http://www.sciencedaily.com/releases/2008/01/080102122306.htm It appears that D3 tests better than D2 in an occasional dosing schedule, like if you got it once a month from a doctor's office. But the assay is apparently flawed and is now known to not measure D2 very well, underestimating its circulating level. For everyday supplementation and fortification, both forms work equally well by all current measures. Some brands with "cultured" or "fermented" ingredients apparently believe that adding lanolin-sourced vitamin D3 to a yeast culture, then drying the whole thing and using it to make vitamins, somehow transmutes the animal fat form of the vitamin into a Vegan-friendly ingredient. They say that the yeast consumes the lanolin-derived vitamin and that the yeast is Vegan no matter what it is fed. But they present no evidence that yeast consumes vitamin D or changes it in any way. Quite the contrary; they brag about providing vitamin D3 – a known animal product - in a supposedly Vegan supplement. This indicates that they know that the form is not changed in any significant way by the yeast culture. One major brand, when asked by me only today, said that they do not disclose their D3 source for their vitamin labeled as Vegan because the source is both "irrelevant" and "proprietary". In other words, they won't tell us and we don't need to know. That pisses me off, pardon me for taking this apparent contempt for Vegans personally. I am not a Vegan but have been a vegetarian since 1972. I do not eat any type of flesh; avoiding not only all forms of meat but also animal broths, gelatin and leather. I scrutinize labels to assure that I am getting no animal products except for dairy, eggs, and honey. Now the Honest Nutritionist in me wants to sound the alarm that some companies are using animal products like gelatin and lanolin in their Vegan-claimed dietary supplements. Whether it's an honest (though sloppy) mistake or a deliberate attempt to have their cake and eat it too is hard to say for sure, but either way this is not fair to Vegans. I tend to fear the worst since they claim the supposedly superior and more popular D3 form in a product whose label also appeals to Vegans and Vegetarians who are being led to erroneously believe that there is now a Vegan-friendly source of D3. There isn't. It is just not true. We are being misled. D3 is not Vegan. D2 is, and is not a bad form as some try to claim. Some medical experts even want to routinely fortify the food supply with D3 because of the largely mythical superiority of that form; that would deprive all Vegetarians and Vegans of their right to avoid hidden animal products in our food. I believe that we have a fundamental right to select our diets based on individual religious, ethical, and cultural beliefs. It is wrong for a corporation to take that right away from us by incorrectly labeling their products that are marketed to Vegetarians and marked as Vegan. Mislabeled products are considered to be adulterated. Obviously, there is no safety issue here and it does not seem as if this matter has attracted much attention, as of yet. But these jokers have attracted my attention and I think that they deserve to get grassroots attention to their attempt to sell non-Vegetarian products to Vegetarians and Vegans. I am not naming names here but will not buy products made by any companies which suggest that animal-source D3 can ethically be sold to Vegans. If you are of the Vegetarian or Vegan persuasion, please check your product labels. If I see vitamin D3 in a product labeled as Vegetarian, I’d feel free to return it to the store as a mislabeled product and get my money back. Vote with your dollars and read product labels carefully before buying anything. If enough people do this, the companies with questionable products will have to deal with a lot of returns from unhappy customers and stores, combined with a drop in sales. Eventually, they will be forced to either correct their labels or change their formulas.

Vioxx withdrawn

ARTHRITIS DRUG WITHDRAWN, PEOPLE ARE LOOKING FOR ALTERNATIVES By Neil E. Levin, CCN, DANLA A major pharmaceutical company has announced a worldwide recall of its top arthritis drug due to cardiovascular problems seen in long-term users. Merck has withdrawn Vioxx from the market after a study was halted because users of the drug had 200% as much risk of getting heart attacks than participants taking a placebo. Medical experts are advising patients taking Vioxx to consult with their physicians about a substitute. If you are one of these people, there is no better time than now to discussthe use of natural alternatives to drugs with your doctor. If you can get temporary relief of aches and pains by using natural herbs and foods with minimal side effects rather than with more dangerous prescription drugs, why not? After all, dangerous side effects are one reason why drugs have restrictions on their sale in the first place. You have three basic choices to inhibit inflammation. Here they are, one at a time: PRESCRIPTION COX-2 INHIBITORS COX-2 Inhibitors help to prevent inflammation from developing by blocking the action of a certain chemical called COX-2. These drugs are noted for reducing "risk of clinically important GI (gastrointestinal) events" by some 50-60% versus non-steroidal anti-inflammatory drugs like aspirin and ibuprofen. However, most of the COX-2 Inhibitor drugs are also associated with an increased risk of cardiovascular problems. And there are still a goodly number of GI complaints in the COX-2 groups. Now one of the most prominent COX-2 inhibitor drugs has been pulled off the market for doubling the rate of heart attacks. Over-The-Counter NSAIDs (non-steroidal anti-inflammatory drugs) Doctors reportedly recommend NSAIDs, which are COX inhibitor drugs like aspirin and ibuprofen, more than they prescribe COX-2 inhibitor drugs like Celebrex and Vioxx. But there are also problems with NSAIDs. Gideon Bosker, MD, Assistant Clinical Professor at Yale University School of Medicine, reports on the use of NSAIDs for Osteoarthritis (OA) and Rheumatoid Arthritis (RA): "As every primary care practitioner knows, NSAID-associated GI toxicity has become a public health problem, especially among older patients with OA and RA. Gastrointestinal intolerance has been reported in up to 50% of patients on long-term NSAIDs. "NSAIDs cause irritations in the gastrointestinal tract, leading to bleeding and iron loss. (Bjarnason I, Macpherson AJ. Intestinal toxicity of non-steroidalanti-inflammatory drugs. Pharmacol Ther 1994;62:145-57) Going off drugs like aspirin and ibuprofen often causes a rebound effect that creates a cascade of inflammation in the Cox and Lox enzyme pathways. In one report the levels of these inflammatory markers was over 500% higher even two weeks after going off aspirin and ibuprofen! (Endres S. Oral aspirin and ibuprofen increase cytokin-induced synthesis of IL-1 beta and of tumour necrosis factor-alpha ex vivo. Immunology 1996;87(2): 264-270) Ibuprofen has caused kidney dysfunction and water retention. (Threlkeld DS, ed. Central Nervous System Drugs, Nonsteroidal Anti-Inflammatory Agents, Facts and Comparisons Drug Information. St. Louis,MO: Mar 1993, 251j-1l) There are about 16,000 deaths a year from NSAIDs, and 100,000 people hospitalized with serious complications. NSAIDs are blamed for over half of all liver failures in this country. These serious side effects have caused a demand for the COX-2 inhibitor drugs, which do not inhibit the COX-1 enzyme like some NSAIDs do. Two recent large studies (called CLASS and VIGOR) looked at the relative safety of NSAIDs versus COX-2 drugs. NSAIDs were shown to be associated with significantly more upper G.I. tract complications, including ulcers and bleeding. Partly because of such studies, COX-2 drugs have become a major success story for pharmaceutical companies over the past few years, becoming a multi-billion dollar a year business. Research published in the British Medical Journal found that 21% of adults with asthma are sensitive to aspirin. Aspirin may trigger a deadly reaction; as may ibuprofen, diclofenac and naproxen. The doctors recommend new warning labels on all products containing these drugs. DIETARY SUPPLEMENTS There are dietary supplements that may help control the inflammation associated with osteoarthritis. In some cases these will block the inflammatory COX-2 enzyme while not blocking the beneficial COX-1 enzyme. Some of these supplements will also block the 5-LOX inflammatory enzyme that is not blocked by many of the arthritis symptom relief drugs. SAMe (S-Adenosylmethionine) has been studied for depression, arthritis, and a host of other ills. Pronounced "Sam-ee", this substance was deemed effective enough to be studied in comparison to the COX-2 Inhibitor drug celecoxib (Celebrex), reportedly the least dangerous COX-2 drug in terms of cardiovascular risks. In this study 61 patients were enrolled in a randomized, double-blind, cross-over trial over a 4-month period. The researchers found that "SAMe is equivalent in almost all measures to COX-2 inhibitors (celecoxib) in relieving pain and improving function in subjects with osteoarthritis of the knee." Their functional parameters included depression, pain, impairment of physical activity and knee mobility and strength. The anti-inflammatory effects of aspirin and other drugs can also be achieved more safely with concentrated blends of spices and herbs that have a wide range of benefits. These formulas will block the COX-2 enzyme, which triggers inflammation in tissues as a response to chemical signals. NSAIDs block not only the inflammatory enzyme COX-2, but also the beneficial enzyme COX-1. The natural ingredients do not have this problem, because they block only the inflammatory enzymes. These natural ingredients will prevent the actions of not only the COX-2 inflammatory enzyme, but also of the 5-LOX inflammatory enzyme that the drugs do not usually affect. Look for an herbal formula that uses ingredients that have been shown to be helpful for inflammation and joint health, and also promoting normal cell growth (preventing abnormal growth). It should contain highly concentrated common spices like ginger and turmeric, which have been naturally extracted to contain the therapeutic chemicals in the plants. Other ingredients that will enhance an herbal formula are holy basil, EGCg-rich green tea extract, Boswellia, the antioxidant resveratrol and the enzyme bromelain (which helps digest damaged tissues so the inflammation can subside and you can rebuild). The herbs also serve as antioxidants and mild anticoagulants (bloodthinners). RELATIVE SAFETY The tremendous safety difference between dietary supplements and drugs is staggering. There are over 100,000 deaths a year from drugs versus a handful from all dietary supplements, which are far safer than any other category offered. Our risk of dying from eating dinner is far greater than from taking any dietary supplement. originally published September 30, 2004

Bias Against Natural Products

Bias Against Natural Products By Neil E. Levin, CCN, DANLA www.honestnutrition.com June 8, 2009 Once again, a widely distributed article has savagely attacked the safety and efficacy of natural products; including vitamins, minerals, and herbs. That this article may be more commentary than journalism is immediately revealed by the author inexplicably linking energy medicine (with admitted health benefits for patients) with a concocted image of “shooing evil spirits”, even when performed by technicians in a top trauma hospital. The ignorance of journalists and medical experts is exposed when they claim that natural products are intended as cures and treatments. These products are actually prohibited by law from claiming this; allowed only documented claims to support healthy body structures and functions. Ironically, this is the same law – the Dietary Supplement Health and Education Act, DSHEA - that is falsely mischaracterized as “deregulation” of the industry. In fact, this law prohibits new ingredients without FDA pre-approval; empowers the agency to regulate manufacturing, advertising, and label claims; prohibits unsafe, adulterated, and mislabeled products; and even allows banning a product based on only theoretical risks. A recent companion law requires all serious adverse events be reported to the FDA; generating far fewer reports than expected. The erroneous assumption that dietary supplements should be considered as potential treatments or cures has resulted in many negative reports. One problem is that some medical researchers, perhaps too used to drug studies using novel substances, sometimes base reports mainly on supplementation levels but fail to properly understand or explain other relevant variables such as dietary intake and relationships to other nutrients that affect body levels and functions of the targeted nutrient. The synergies of natural substances in the diet are complex and interactive, but many researchers design simplistic studies that generate incomplete or misleading data; often leading to dramatic conclusions that the pharmaceutical advertising-dependent press eats up. A press that fails to investigate and present all of the relevant facts and perspectives in a sensational negative report may be accused of laziness, if not bias. Rigorous studies refuting negative reports about the safety of vitamin E, beta-carotene, herbs, the use of supplements with cancer treatments, and drug-nutrient interactions have been noticeably absent from the same media that eagerly broadcasts reports attacking nature’s own nourishing substances. Sadly, there is no matching eagerness to set the record straight. Let’s keep this in perspective. We have all seen drugs pulled from the market because of unforeseen safety issues, medical schools and authors of articles published in peer-reviewed journals accused of being on the take from pharmaceutical companies, contaminated drugs as well as hundreds of thousands of deaths and millions of hospitalizations caused by pharmaceutical side effects each year. Foods cause hundreds of deaths and millions of illnesses annually. Compare this to dietary supplement safety, where proven deaths are extremely rare. Supplement users believe in the healing power of nature, at odds with the often unproven treatments of conventional medicine. The goal of Integrative Medicine is putting aside traditional institutional medical bias to allow science to dictate the comprehensive treatment of an individual patient, including quality of life issues. Many millions of Americans choose to use natural products in order to protect and improve their own health and vitality. Reasonable people will reject these sensational assaults on natural health (including dietary supplements), recognizing that conventional medicine sometimes fails without a little help from Mother Nature. References: Cancer patients may very well tolerate the use of certain dietary supplements http://caonline.amcancersoc.org/cgi/eletters/55/5/319#176 The truth about Vitamin E - Vitamin E is safer than implied http://www.bmj.com/cgi/eletters/330/7490/0-f#99008 Scientists to discuss benefits of vitamin E http://www.nutraingredients-usa.com/Research/Scientists-to-discuss-benefits-of-vitamin-E Vitamin review offers balanced perspective to recent negative findings http://www.worldhealth.net/news/vitamin_review_offers_balanced_perspecti Antioxidant supplements - myth or misunderstood? http://www.nutraingredients.com/Research/Antioxidant-supplements-myth-or-misunderstood Prominent Nutritionist Sets The Record Straight http://www.the-health-gazette.com/health-gazette-blog/nutrition/prominent-nutritionist-sets-the-record-straight FDA regulation of dietary supplements is sufficient http://www.journalgazette.net/apps/pbcs.dll/article?AID=/20090131/EDIT09/301319890/-1/AP05 Impact of antioxidant supplementation on chemotherapeutic efficacy: a systematic review of the evidence from randomized controlled trials. Block KI, Koch AC, Mead MN, Tothy PK, Newman RA, Gyllenhaal C. Cancer Treat Rev. 2007 Aug;33(5):407-18. Epub 2007 Mar 23. Review. PMID: 17367938 Antioxidants and other nutrients do not interfere with chemotherapy or radiation therapy and can increase kill and increase survival, part 1. Simone CB 2nd, Simone NL, Simone V, Simone CB. Altern Ther Health Med. 2007 Jan-Feb;13(1):22-8. Review. PMID: 17283738 Should patients undergoing chemotherapy and radiotherapy be prescribed antioxidants? Moss RW. Integr Cancer Ther. 2006 Mar;5(1):63-82. Review. PMID: 16484715 Multiple dietary antioxidants enhance the efficacy of standard and experimental cancer therapies and decrease their toxicity. Prasad KN. Integr Cancer Ther. 2004 Dec;3(4):310-22. Review. PMID: 15523102 The efficacy and safety of multivitamin and mineral supplement use to prevent cancer and chronic disease in adults: a systematic review for a National Institutes of Health state-of-the-science conference. Huang HY, Caballero B, Chang S, Alberg AJ, Semba RD, Schneyer CR, Wilson RF, Cheng TY, Vassy J, Prokopowicz G, Barnes GJ 2nd, Bass EB. Ann Intern Med. 2006 Sep 5;145(5):372-85. Epub 2006 Jul 31. Review. PMID: 16880453 Higher baseline serum concentrations of vitamin E are associated with lower total and cause-specific mortality in the Alpha-Tocopherol, Beta-Carotene Cancer Prevention Study. Margaret E Wright, Karla A Lawson, Stephanie J Weinstein, Pirjo Pietinen, Philip R Taylor, Jarmo Virtamo and Demetrius Albanes. American Journal of Clinical Nutrition, Vol. 84, No. 5, 1200-1207, November 2006. (Researchers were from the Nutritional Epidemiology and the Genetic Epidemiology Branch, Division of Cancer Epidemiology and Genetics, and the Cancer Prevention Fellowship Program, Division of Cancer Prevention, National Cancer Institute, National Institutes of Health, Bethesda, MD, and the Department of Health Promotion and Chronic Disease Prevention, National Public Health Institute, Helsinki, Finland) Vitamins E and C are safe across a broad range of intakes. John N Hathcock, et al. REVIEW ARTICLE: American Journal of Clinical Nutrition, Vol. 81, No. 4, 736-745, April 2005. Potential for interactions between dietary supplements and prescription medications. Sood A, Sood R, Brinker FJ, Mann R, Loehrer LL, Wahner-Roedler DL; (Mayo Clinic). Am J Med. 2008 Mar;121(3):207-11. PMID: 18328304 Acute adverse effects of radiation therapy and local recurrence in relation to dietary and plasma beta carotene and alpha tocopherol in head and neck cancer patients. Meyer F, Bairati I, Jobin E, Gélinas M, Fortin A, Nabid A, Têtu B. Nutr Cancer. 2007;59(1):29-35. PMID: 17927499 Interaction between antioxidant vitamin supplementation and cigarette smoking during radiation therapy in relation to long-term effects on recurrence and mortality: a randomized trial among head and neck cancer patients. Meyer F, Bairati I, Fortin A, Gélinas M, Nabid A, Brochet F, Têtu B. Int J Cancer. 2008 Apr 1;122(7):1679-83. PMID: 18059031 The total antioxidant capacity of the diet is an independent predictor of plasma beta-carotene. Valtueña S, et al. Eur J Clin Nutr. 2007 Jan;61(1):69-76. Epub 2006 Jul 12. PMID: 16835597 [Supported by the European Community IST-2001–33204 'Healthy Market', the Italian Ministry of University and Research COFIN 2001 and the National Research Council CU01.00923.CT26 research projects.] No influence of beta carotene on oxidative DNA damage in male smokers. van Poppel G, Poulsen H, Loft S, Verhagen H. J Natl Cancer Inst. 1995 Feb 15;87(4):310-1. PMID: 7707423 Lack of effect of long-term supplementation with beta carotene on the incidence of malignant neoplasms and cardiovascular disease. Hennekens CH, Buring JE, Manson JE, et al. N Engl J Med. 1996 May 2;334(18):1145-9. PMID: 8602179 Lee IM, Cook NR, Manson JE, Buring JE, Hennekens CH. Beta-carotene supplementation and incidence of cancer and cardiovascular disease: the Women's Health Study. J Natl Cancer Inst. 1999 Dec 15;91(24):2102-6. PMID: 10601381 The Alpha-Tocopherol, Beta Carotene Cancer Prevention Study Group. The effect of vitamin E and beta carotene on the incidence of lung cancer and other cancers in male smokers. N Engl J Med. 1994 Apr 14;330(15):1029-35. PMID: 8127329 Development of a comprehensive dietary antioxidant index and application to lung cancer risk in a cohort of male smokers. Wright ME, et al. Am J Epidemiol. 2004 Jul 1;160(1):68-76. PMID: 15229119 Plasma carotene and alpha-tocopherol in relation to 10-y all-cause and cause-specific mortality in European elderly: the Survey in Europe on Nutrition and the Elderly, a Concerted Action (SENECA). Buijsse B, et al. Am J Clin Nutr. 2005 Oct;82(4):879-86. PMID: 16210720 Effect of multivitamin and mineral supplementation on episodes of infection in nursing home residents: a randomized, placebo-controlled study. Liu BA, et al. J Am Geriatr Soc. 2007 Jan;55(1):35-42. Erratum in: J Am Geriatr Soc. 2007 Mar;55(3):478. PMID: 17233683 Nutrition intervention trials in Linxian, China: supplementation with specific vitamin/mineral combinations, cancer incidence, and disease-specific mortality in the general population. Blot WI, Li IY, Taylor PR, et al. J Natl Cancer Inst 1993:8ı:1483-92 Nutrition intervention trials in Linxian, China: multiple vitamin/mineral supplementation, cancer incidence, and disease-specific mortality among adults with esophageal dysplasia. Li JY, Taylor PR, et al. J Natl Cancer Inst. 1993 Sep 15;85(18):1492-8. PMID: 8360932 The Linxian trials: mortality rates by vitamin-mineral intervention group. Blot WI, et al. Am J Clin Nutr. 1995 Dec;62(6 Suppl):1424S-1426S. PMID: 7495242 Vitamins for Chronic Disease Prevention in Adults: clinical applications. Fairfield KM, Fletcher RH. JAMA. 2002;287:3127-3129.) Food-related illness and death in the United States. Mead PS, et al. Emerg Infect Dis. 1999 Sep-Oct;5(5):607-25. Review. PMID: 10511517 American Association of Poison Control Centers annual reports FROM THE CENTERS FOR DISEASE CONTROL AND PREVENTION: Unintentional Poisoning Deaths—United States, 1999-2004. JAMA, March 28, 2007; 297: 1309 - 1311. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. Lazarou J, Pomeranz BH, Corey PN. JAMA. 1998 Apr 15;279(15):1200-5. PMID: 9555760 Washington Post reported in its 7/21/06 edition on an Institute of Medicine study released a day earlier on the toll of improperly prescribed drugs. http://www.youtube.com/watch?v=qxAR7waukVc

testing dietary supplements

My experience with dietary supplements is that analysis of products with multiple ingredients, especially those at low concentrations, is very difficult and requires experience with the particular supplement matrix (formula plus excipients). Random testing of products off the shelf is fraught with technical difficulties. In addition, many ingredients lack standard, universally accepted testing methods within a dietary supplement matrix, which can result in confusion. These are sophisticated issues, whose resolution sometimes is difficult for anyone trying to ascertain product quality based on limited testing and lack of relevant experience. That is why most labs prefer to test single ingredient products, a tacit admission of the uncertainties involved in testing complex formulations. Testing is not as black and white as news releases often indicate or imply. Further, extrapolation of analytical results to nutrition, health and safety issues also requires expertise in these sometimes controversial areas, which very few labs have. It is important to verify label claims, but sometimes the manufacturer's validated procedures for qualification of an individual ingredient - combined with appropriate quality controls to assure that a proper mixture has been made - may more accurately represent the quality and quantity of that ingredient in a formula than any lab results obtained by applying a single analytical test to vastly different formulations containing that ingredient.