Is citric acid made from black mold?

Yes, but so what? That organism - Aspergillus niger - has been used to safely manufacture citric acid for about 100 years. It's also used to make most of the 'fungal enzymes' that are vegetarian-friendly. People consuming citric acid are not eating black mold; just as you're not eating bees when consuming honey. 

People worried about the fermentation process have failed to distinguish between the mold and its purified byproducts that have a long history of safe use.  https://link.springer.com/article/10.1007/s00253-002-1032-6  

The fungus produces materials outside of its body that can be easily isolated and purified, so people are not inhaling or consuming mold when they use a material produced by fermentation. In fact, companies using citric acid perform their normal microbiological screening to assure that there are not concerning levels of mold in that material..

The mold itself would release spores that would be toxic to inhale if it were growing in your house. It may be mildly allergenic if you were eating the actual mold. But that's not what we are exposed to or are consuming when we eat citric acid, which is widely distributed in the processed food chain and has an important role in acidifying and preserving many foods and beverages. Look at your labels!

Isolated Aspergillus-derived products, including citric acid, have been sold for about a century and are considered safe. These also include common plant-derived enzymes such as protease, amylase, and lipase that are not pancreas-derived.  https://fungalbiolbiotech.biomedcentral.com/articles/10.1186/s40694-018-0054-5 

"Microbial citric acid has high economic importance and widely used in beverage, food, detergents, cosmetics and pharmaceutical industries. The filamentous fungus Aspergillus niger is a work horse and important cell factory in industry for the production of citric acid."   https://pubmed.ncbi.nlm.nih.gov/33044884/

"Aspergillus niger has a long tradition of safe use in the production of enzymes and organic acids (Soares de Castro et al., 2015)."  https://www.sciencedirect.com/topics/pharmacology-toxicology-and-pharmaceutical-science/aspergillus-niger#:~:text=The%20Aspergillus%20produces%20different%20types,et%20al.%2C%202015).

 

Federal Dietary Supplement Registry bills

 Dietary Supplement Legislation Misguided & Inflationary

A bill sponsored by Senators Durbin (D-IL) and Braun (R-IN) - S.4090, the Dietary Supplement Listing Act - mandates a registry of all dietary supplements, citing safety concerns. Meanwhile, the Senate Health, Education, Labor, and Pensions (HELP) Committee also added mandatory product registration for this non-drug category to must-pass prescription drug user fee legislation S.4348, the Food and Drug Administration Safety and Landmark Advancements Act of 2022 (FDASLA). 

These concerns are overblown; the proposed solution draconian. Why treat an overwhelmingly safe food category as inherently dangerous? Multivitamins, vitamin C, calcium, fish oil, and common nutrients are non-toxic, with few safety concerns.

Senator Durbin uses Adverse Event Reports (AERs) as justification. But Mr. Durbin knows AERs are defined as associative, not proof of a causal relationship. I manage a team handling dietary supplement AERs for a responsible manufacturer, which are promptly investigated and reported to the FDA. The few AERs we receive are typically caused by pre-existing conditions/known drug effects, not supplements. And many dietary supplement AERs received by FDA involve multivitamin choking issues, not toxicity. 

There are potential interactions between certain ingredients and certain drugs. A published report of Mayo Clinic patient records identified only five such ingredients, noting only minor negative drug interactions. Statistics from the authoritative American Association of Poison Control Centers confirm zero deaths are associated with dietary supplements most years. Official AERs, not necessarily caused by supplements, showed only 166 hospitalizations and 22 deaths over an 11-year, 4-month period. By contrast, CDC estimates 48 million illnesses, 128,000 hospitalizations, and 3,000 deaths from foodborne diseases each year; food allergies cause 15 million illnesses, 30,000 ER visits and 150–200 deaths. Taking a dietary supplement is statistically far safer than eating a meal. 

If there is a safety issue, FDA already has the power to ban products, as it did with the herb ephedra. Facility registration is already mandated in existing Bioterrorism and Food Safety laws, but S.4090 inexplicably removes carefully designed antiterrorist protections. The National Institutes of Health already have a huge dietary supplement label database, which the FDA seeks to duplicate in a wasteful agency rivalry. 

S.4090 imposes large fines - and jail terms - for not getting advance bureaucratic permission to market any supplement, even vitamin C. Companies must seek registration numbers and identify individuals to be severely penalized for infractions, with sales restricted by agency refusal or delay. Why does the FDA need absolute veto power over every vitamin; adding red tape and inflationary costs? The FDA already has statutory authority to inspect manufacturers, review labels and batch records, and confirm AERs are being properly handled/reported. Since the rationale is lack of enforcement of existing laws, how does piling on new regulations, fees, and harsh penalties solve that persistent agency problem? An analogy: would new laws lowering the speed limit and requiring drivers to keep mileage logs stop speeders, or is enforcement the real solution? 

The dietary supplement industry welcomes reasonable consumer protections. We supported laws giving FDA authority over ingredients, label claims, Good Manufacturing Practices (GMP), facility inspections, food safety practices, facility registration, adverse event reporting, steroid bans, and allergen labeling. We’ve repeatedly lobbied Congress for higher FDA enforcement budgets to weed out bad actors, but oppose universal pre-market approval.

Why is a safe food category – dietary supplements – targeted for harsh regulation and higher costs, strangling innovation and consumer needs? If safety is the issue, why shouldn’t riskier food manufacturers (allergens and food poisoning) also need pre-market approval, their employees targeted for prosecution and fines? This is a punitive bill targeting an overwhelmingly safe product category for no justifiable reason. 

Neil Edward Levin, CCN, DANLA

NOW Health Group

Bloomingdale, Illinois

Aspergillus Niger Safety

Fermentation is a process where a microorganism is utilized as a factory to produce certain nutrients or other biologically useful substances for humans. The culture, environment, and feed can encourage production of various products including enzymes and organic acids that are commonly used in foods and supplements. Some molds are benign; think of Saccharomyces boulardii (related to the yeasts in bread or beer) or blue cheese. 

While Aspergillus niger is a black mold, it is not the black mold that contaminates homes. As with the enzymes produced by A. niger, inhalation of mold or enzymes is not healthy for the lungs, and precautions are taken during production. In addition, A. niger is considered GRAS (generally regarded as safe) by the FDA and has been used for a century to produce citric acid and enzymes. Enzymes produced by A. niger do not contain significant amounts of the culture after isolation and purification to USP monograph standards of purity. Just as milk does not contain a cow, enzymes produced by A. niger do not inherently contain black mold. 

The U.S EPA has reported: 

“Exposure to Aspergillus must be nearly universal but disease is rare. The physiological condition of the exposed individual thus appears to be of paramount importance. Patients exhibiting aspergillosis are generally immunocompromised, and thus susceptible to otherwise common and usually harmless microorganisms. Factors that may lead to immunosuppression include an underlying debilitating disease (e.g., chronic granulomatous diseases of childhood), chemotherapy, and the use of supraphysiological doses of adrenal corticosteroids (Bennett, 1980)…A. niger is not a significant human pathogen. Throughout years of use and widespread exposure to A. niger in the environment, there are only several reports of aspergillosis with A. niger, and in Nigeria, one report of a number of cases of otomycosis. There have been only several reports of allergic reactions, which are not uncommon for aspergilli in general, and not unique to A. niger. A. niger is capable of producing several mycotoxins. However, mycotoxin production appears to be controlled by the conditions of fermentation.”  

EPA’s Final risk assessment for Aspergillus niger https://www.epa.gov/sites/production/files/2015-09/documents/fra006.pdf

https://pubmed.ncbi.nlm.nih.gov/12172605/

Is Carrageenan Safe or Dangerous?

Undenatured carrageenan is a natural stabilizer, binding agent, and emulsifier used in products such as toothpaste in place of SLS and other truly undesirable ingredients commonly used in mass market products. It is also used in some vegan-friendly softgel capsule material as an alternative to animal-derived gelatin.

There is an Internet myth that carrageenan is unsafe; due primarily to confusion with a so-called “denatured carrageenan” polymer that is actually poligeenan, a heavily processed low molecular weight seaweed derivative currently used only as an x-ray imaging component. Poligeenan, previously used in pharmaceuticals, is quite different from the undenatured high molecular weight material that we use. Due to the safety concerns over poligeenan, regulations routinely require the carrageenan added to foods to have high molecular weight to ensure its integrity. But there are no unresolved safety concerns with undenatured carrageenan. 

Carrageenan has been thoroughly vetted by national and international public health authorities over a number of decades, even recently in response to the ongoing blogger-driven controversies, so there is no remaining basis of concern. Even its use in infant formulas was recently reconfirmed to be safe, and it’s helpful in distributing the nutrients more evenly to avoid the settling out that could otherwise cause uneven nutrient intake when a bottle is only partially consumed. 

After repeated investigations, the evidence for carrageenan safety is stronger than ever. Carrageenan is extremely safe and present in a number of healthy seaweeds; only the denatured form of carrageenan - a drug - is toxic. 

References:        

·        Public health and carrageenan regulation: a review and analysis. Borowitzka et al. (eds.), Nineteenth International Seaweed Symposium. DOI: 10.1007/978-1-4020-9619-8_8. Developments in Applied Phycology.

·         http://www.ncbi.nlm.nih.gov/pubmed/24467586

·         http://www.foodproductdesign.com/blogs/formulating-foods/2014/07/fao-who-carrageenan-safe-in-infant-formula.aspx

·         http://www.ncbi.nlm.nih.gov/pubmed/12389870

·         http://www.foodinsight.org/blogs/why-you-should-care-about-carrageenan

Limits on Oral Potassium in tablets and capsules

The U.S. Food and Nutrition Board (FNB) has established an Adequate Intake (AI) of 4.7 grams/day of potassium in a healthy adult. A tolerable upper limit (UL) was not established for potassium since there was no evidence of adverse effects from a high level of potassium from foods consumed by healthy adults.

Potassium is a food substance and is affirmed as generally recognized as safe (GRAS) by the U.S. FDA (21 CFR 184.1622) (FDA, 2012a). In October 2000, food containing at least 350 mg potassium and 140 mg or less of sodium was approved by the FDA to have the following health claim on product labeling: "Diets containing foods that are good sources of potassium and low in sodium may reduce the risk of high blood pressure and stroke." (FDA, 2012b; NMCD, 2012).

Some experts suggest that a single dose of potassium should be limited to 500 mg, while a total of 1,500 mg daily is considered safe for general supplementation. This is well within the AI level.

The 99 mg. limit on potassium tablets and capsules is based on a remote risk of a pill damaging the intestinal wall if it releases its content slowly. That risk does not apply to liquid forms, or to powders that are mixed with liquids. While higher amounts are allowable, a long warning is required on all potassium products intended for oral ingestion providing 100 mg or more of the mineral in a capsule or coated tablet form: http://law.justia.com/cfr/title21/21-4.0.1.1.2.7.1.7.html

Calcium and Vitamin D are Safe for Heart Health

Huge study of ½ million adults age 40-69: calcium & D supplements pose no cardiovascular risk (heart attack, etc.) in the UK Biobank study:

fb.me/IOHg07RL

Does Borage Seed Oil contain PAs (Pyrrolizidine Alkaloids)?

Borage Oil does NOT contain detectable levels of PAs (Pyrrolizidine Alkaloids), because they are not co-extracted from the seed along with the oil. In the definitive study "Pyrrolizidine Alkaloid Content in Crude and Processed Borage Oil from Different Processing Stages" published in the highly reputable Journal of the American Oil Chemists Society [JAOCS, Vol. 80, no. 10 (2003)] it was stated:

"The pyrrolizidine alkaloid content of crude borage oil and borage oil from different processing stages was determined by GC-MS. The results showed that no pyrrolizidine alkaloids were present above a detection limit of 20 ppb. The reduction factors for pyrrolizidine alkaloids at various stages in the oil refining process were determined by means of spiking experiments using the commercially available pyrrolizidine alkaloid crotaline. It was shown that the pyrrolizidine content in crude borage oil was reduced overall by a factor of about 30,000 in the refining process."

Based on the scientific evidence, since manufacturers use refined borage seed oil their Borage Oil products would never be expected to contain any measurable PAs (at the current 20 parts-per-billion detection level).

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

Does Fish Oil Dissolve Styrofoam - and Does That Prove It's Bad?

Recent attention given to the effects of various fish oils on polystyrene (Styrofoam®) cups has led to some misunderstanding of how these products work in terms of nutrition and safety. It is unfortunate that the use of these stunts imply may confuse or even scare people away from taking this natural product which provides constituents that are essential to human health. Don’t be fooled by this trick! If someone tries to use it as a means to push one product over another, challenge them to explain exactly what the test is supposed to mean. Here’s what you need to know about the test, how it works, and what it means:
Styrofoam® (polystyrene) cups can be dissolved by pure fish oils. All fish oils will have this same effect on polystyrene, but some will take much longer than others. Various healthy natural substances, like fresh lemon oil, will also dissolve polystyrene. In the Styrofoam® cup test, the esterified ethyl ester form of fish oil works to dissolve Styrofoam® much faster than the triglyceride form simply because the number of chemical bonds in the two forms of oil are different; with ethyl ester fish oil having its number of bonds closer to that of Styrofoam®. This similar chemical polarity is the same reason why pure lemon oil also works quickly to dissolve Styrofoam®. No solvents are used to produce the fish oils, so none are present in the finished products. This magic trick does not translate into any legitimate safety concerns, despite its obvious visual impact. Fortunately, the human body is not composed of polystyrene and is not negatively affected by fish oils in its commonly available forms.

Fish oil naturally comes in a volatile triglyceride (triacylglycerol) form and can be esterified for additional benefits. As soon as a fish is caught the oils begin to degrade and can easily go rancid. Esterification is a process that stabilizes and maintains the freshness of fish oil to prevent rancidity and allows higher concentrations of the essential omega-3 EPA and DHA fatty acids to be available. During this esterification process, the triglycerides are removed, changing the number of molecular bonds in the fish oil. Both the purified ethyl ester form and the triglyceride form must be digested to a simpler fraction, the free fatty acid, to allow bioavailability from the human gut. Ethyl ester and triglyceride forms are equally well digested by lipase and available for absorption as free fatty acids, and the ethyl ester form is at least as bioavailable as the triglyceride form. (1)

There is some evidence that the ethyl ester form will sustain circulating levels of the omega-3 fatty acids EPA and DHA better than the triglyceride form. The ethyl ester form of EPA and DHA is the form that is used in most successful clinical studies evaluating the potential health benefits of supplemental Omega-3 fats. In fact, clinical trials on the ethyl ester form more consistently generate positive results than those done with the triglyceride form. Also EPA and DHA as ethyl esters inhibit platelet aggregability and control serum triglycerides while leaving other serum lipids essentially unaltered. (2) The ethyl ester forms build up body stores, allowing conversion to free fatty acids more consistently than the triglyceride form. (3) Because of their proven benefits and safety, it would be unfortunate if a misunderstood “test” causes some people to reject the use of solvent-free ethyl ester fish oils as part of their diet.

Expert opinion:

http://www.biosyntrx.com/articles.php?id=690

http://www.newton.dep.anl.gov/askasci/chem03/chem03994.htm

------------------------------------------------------------------------------------------------------------
Technical explanation:

Chemical Polarity plays a role in how compounds react with one another. Polarity refers to the electro-magnetic charges of a molecule, or the attraction between the positively and negatively charged parts of a molecule. Compounds are considered polar due to the unequal sharing or electrons. For example, water is a polar compound. A compound is non-polar when the electric charge is balanced. Edible oils are typically non-polar.

In Chemistry there is a rule to describe how polar and non-polar solvents react with similar solutes: “like dissolves like”. We all know that oil and water do not mix. The reason why is that water, which is polar, will not react (mix) with oil, which is non-polar. “Like dissolves like.”

Two common compounds, sugar and salt, are both polar and in nature they readily mix with water, another polar compound.

With polarity, compounds of differing polarity do not react/mix, while those with like polarity do mix. So a chemical reaction occurs when a non-polar compound comes into contact with another non-polar compound, and more readily when the number of chemical bonds in one substance more closely matches the other.

Polystyrene, a moisture-resistant foam commonly known as Styrofoam®, is formed from a long chain of polymers. This plastic is used in the manufacture of coffee cups and plates as an insulator and as packaging material, and is non-polar. What makes Styrofoam® ideal for keeping most hot beverages hot and cold beverages cold is that as a non-polar compound it will not react with the polar water used to make coffee, tea, and other beverages. This same material will react with any form of edible oil; this can be olive oil, lemon oil, fish oil, etc. This reaction is naturally occurring and its intensity is based solely upon the chemical properties of both compounds and the polarity of each.

All edible oils, which like Styrofoam® are non-polar, are made up of fatty acids; and these fatty acids are made up of a long chain of hydrocarbon molecules. With Fish Oils, some contain triglycerides and some contain ethyl esters. Both the triglyceride form and the ethyl ester form first need to be digested and broken down to a free fatty acid for absorption from the GI tract. After uptake, the free fatty acid is then converted to a triglyceride form in the liver by the addition of already available triglycerides obtained from circulating lipids (fats).

In the example of fish oils, ALL will react with Styrofoam over time; the length of time is determined by the number of chemical bonds in each type of fish oil relevant to the number of chemical bonds in Styrofoam®. Triglycerides will take longer to react with the cup, while oils bonded to ethyl esters, which have more chemical bonds, will naturally penetrate the cup wall faster.

REFERENCES:

1. Krokan HE, Bjerve KS, Mørk E. The enteral bioavailability of eicosapentaenoic acid and docosahexaenoic acid is as good from ethyl esters as from glyceryl esters in spite of lower hydrolytic rates by pancreatic lipase in vitro. Biochim Biophys Acta. 1993 May 20;1168(1):59-67. PMID: 8504143
2. von Schacky C. A review of omega-3 ethyl esters for cardiovascular prevention and treatment of increased blood triglyceride levels. Vasc Health Risk Manag. 2006;2(3):251-62. Review. PMID: 17326331
3. Rupp H, et al. Risk stratification by the "EPA+DHA level" and the "EPA/AA ratio" focus on anti-inflammatory and antiarrhythmogenic effects of long-chain omega-3 fatty acids. Herz. 2004 Nov;29(7):673-85. Review. Erratum in: Herz. 2004 Dec;29(8):805. PMID: 15580322

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

 

Response to Doctor Oz's "Melatonin: Are You Sabotaging Your Sleep?"

Obviously, the lowest amount (dose) of something that works for you is usually best, but that is true more rigidly for substances with a high potential for dangerous side effects - like pharmaceutical drugs - than for natural substances that the body produces and knows how to properly handle.

The sleep aid Melatonin is normally made from the hormone serotonin, which in turn is metabolized from dietary l-tryptophan, an essential amino acid that must be ingested because it can't be synthesized in the body from other substances like the non-essential aminos can. Melatonin is produced at night time, in darkness, so those of us who sit up in bright rooms and/or watch TV or computer screens late at night are suspect of creating a deficiency due to these unnatural habits.

Melatonin is supposed to rule the night while adrenal hormones rule the day. Melatonin actually suppresses the production of stress hormones, allowing us to relax and get a good night's sleep. But the more stress we're under, and the more we deprive ourselves of the proper conditions to synthesize our own melatonin, the less likely we can get a good night's sleep or shut off the flood of stress hormones (like cortisol) that raise our risks of getting chronic diseases, heart attacks and strokes, nervous eating and belly fat, etc. 

There are legitimate reasons to use higher amounts of melatonin than the fraction of a milligram that some suggest. In fact, for certain populations, higher amounts may be necesary to maintain a balanced health status (homeostasis), even for children.

Here are some authoritative references for higher doses of melatonin; not only for sleep, but for other potential health benefits:


http://webprod.hc-sc.gc.ca/nhpid-bdipsn/monoReq.do?id=136&lang=eng

http://healthlibrary.epnet.com/GetContent.aspx?token=e0498803-7f62-4563-8d47-5fe33da65dd4&chunkiid=21811#P2

http://www.umm.edu/altmed/articles/melatonin-000315.htm

http://www.drugs.com/npp/melatonin.html

http://www.webmd.com/vitamins-supplements/ingredientmono-940-MELATONIN.aspx?activeIngredientId=940&activeIngredientName=MELATONIN

http://reference.medscape.com/drug/n-acetyl-5-methoxytryptamine-pineal-hormone-melatonin-melatonin-344545

http://www.mc.vanderbilt.edu/vhost/vbi/graduate/pdfs/melatonin%20dose-response%20trial.pdf

http://www.naturalstandard.com/demo/demo-pro-melatonin.asp

http://www.wholehealthmd.com/ME2/dirmod.asp?sid=&nm=Reference+Library&type=AWHN_Supplements&mod=&mid=&id=494D7543D6CA42AB987FE5CC3A6C9D0B&tier=2#Dosage_Information

Is FDA wrong on dietary supplement manufacturers' GMP compliance and safety?

Is FDA misleading the public on dietary supplement manufacturers' GMP compliance, thus undermining confidence in safety? Here are two articles, one on possible errors in FDA statements on GMP compliance and the other on dietary supplement safety statistics. You be the judge!

http://www.nutraingredients-usa.com/Industry/Associations-welcome-Durbin-Blumenthal-cGMP-dialogue-but-where-did-the-violation-stats-come-from/?utm_source=newsletter_daily&utm_medium=email&utm_campaign=Newsletter%2BDaily&c=Fe5usULeGc0%2FkfNHpI51Pg%3D%3D

http://www.nutraingredients.com/Regulation/Food-supplements-are-safest-foodstuffs-Report/?utm_source=newsletter_daily&utm_medium=email&utm_campaign=Newsletter%2BDaily&c=laSlNRfz2qByCDCO6koDYw%3D%3D

Bitter Orange Safety Concerns Are Overblown: study

A review of bitter orange safety was published in a peerr-reviewed journal. Analyzing the adverse event reports (AERs) submitted to the FDA, Sidney J. Stohs, dean emeritus of the Creighton University School of Pharmacy and Health Professions, reported that, “The belief that p-synephrine exerts serious cardiovascular and other events continues to be believed by the lay public as well as healthcare professionals, in spite of the lack of clearly defined supportive evidence for this supposition, as well as extensive evidence to the contrary.”



"An 8 oz glass of Californian mandarin orange juice may contain up to 35 mg p-synephrine (USDA). A sweet orange typically contains about 6 mg p-synephrine."


http://www.nutraingredients-usa.com/Industry/Bitter-orange-concerns-unwarranted-and-unjustified-Review/?c=Fe5usULeGc2A9I8d6ljtPw%3D%3D&utm_source=newsletter_daily&utm_medium=email&utm_campaign=Newsletter%2BDaily

Source: Journal of Functional Foods. Published online ahead of print, doi: 10.1016/j.jff.2010.10.003
“Assessment of the adverse event reports associated with Citrus aurantium (bitter orange) from April 2004 to October 2009” Author: S.J. Stohs

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.

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

In Defense of Natural Foods: Fish Oils

In Defense of Natural Foods

By Neil E. Levin, CCN, DANLA

A public debate is now raging over the safety of natural fish oils. In truth, though, this should be more properly recognized as a narrowly focused legal debate rather than representing any real question as to whether these natural food products are good for us to eat; because health authorities around the world have already acknowledged that it is generally better to eat natural fish and fish oils than to avoid them. Yet a quirk in California law makes it possible for some environmental lawyers to argue that the general scientific and medical consensus on the known health benefits of natural fish products be ignored; instead touting zero tolerance for pollutants that are widespread in our food supply and advocating that only highly processed oils be sold.

I am certainly not in favor of pollutants; my bona fides are clear. As a student I led environmental classes in my school on the first Earth Day on April 22, 1970 and have broken whole grain bread with the late Earth Day founder Senator Gaylord Nelson at a natural food Thanksgiving dinner. I spent a day with Al Gore at a solar symposium that he hosted in Tennessee in the late 1970’s. My wife and I live on a 4-acre wooded hillside that is a National Wildlife Federation Certified Wildlife Habitat™. We have recycled, grown and bought organic food, used primarily natural and biodegradable products in our home, politically and financially supported several environmental groups, and otherwise have been ardent environmentalists for some 40 years. I’ve worked in the natural food industry for my entire adult life and am so into it that I became a clinical nutritionist who reads complex nutrition studies for kicks. So when I question other environmentalists for creating a public panic that may turn people off from eating foods that provide scientifically demonstrated health benefits despite the possibility of tiny amounts of pollutants being in them, it may merit some attention.

The attorneys argue that only highly processed fish oils are acceptable; all other fish oil products should have label warnings that they may contain parts-per-billion (ppb) amounts of PCBs, a banned industrial chemical that is still so widespread in the environment that the native people of the far north have it in their bodies from the wild fish that is the base of their traditional diet.

According to the Food and Drug Administration (FDA), “Small amounts of PCBs can be found in almost all outdoor and indoor air, soil, sediments, surface water, and animals. However, PCB levels have generally decreased since PCB production stopped in 1977. People are exposed to PCBs primarily from contaminated food and breathing contaminated air. The major dietary sources of PCBs are fish (especially sportfish that were caught in contaminated lakes or rivers), meat, and dairy products.”

What are the health impacts of PCBs? That is really hard to say. Most negative reports are from rodent studies, where the animals are fed huge amounts for long periods. The FDA reports that, “PCBs are not known to cause birth defects,” and has no cases on record, so that concern seems unfounded, despite the claims of the current private lawsuit. The agency does report that PCBs are probable carcinogens based on such animal studies and cases of industrial workers exposed to substantial amounts of the chemicals. It also reports developmental problems in children of mothers exposed to “high” amounts, but not specifically birth defects and not at significantly harmful levels. “Some studies have estimated that an infant who is breast fed for 6 months may accumulate in this period 6–12% of the total PCBs that will accumulate during its lifetime. However, in most cases, the benefits of breast-feeding outweigh any risks from exposure to PCBs in mother’s milk.”

Fortunately, the FDA has also estimated that the amount of PCBs in food is steadily declining since the chemicals were banned. Between 1978 and 1991, the estimated daily intake of PCBs in adults from dietary sources declined by about 62%. “Meat and dairy products are other important sources of PCBs in food, with PCB levels in meat and dairy products usually ranging from less than 1 part in a billion parts (ppb) of food to a few ppb.” That means a Quarter Pound burger weighing about 113 grams could lawfully contain hundreds of nanograms (billionths of a gram, or parts-per-billion) of PCBs, approaching about half a microgram (a microgram is one-millionth of a gram, or one part-per-million). If you got somewhat less from a natural fish oil, plus enjoyed the added cardiovascular benefits of the essential Omega-3 fatty acids it provides versus the known cardiovascular risks of beef and other animal fats, should that really be a great concern, especially when heart disease is blamed for about half the deaths in this country?

The official Health Canada federal agency reports that, “Exposure to these low levels does not appear to affect human health. Based on recent results from Total Diet Studies (a series of studies organized by Health Canada), the average daily dietary intake of PCBs is thought to be less than half of one microgram (one microgram = one-millionth of a gram). People who eat large amounts of sports fish, wildlife or marine mammals may be exposed to higher dietary levels of PCBs…Media reports have raised concerns about PCBs in farmed salmon. Health Canada and the Canadian Food Inspection Agency recently completed a survey of farmed and wild fish. The survey analyzed a large number of samples for PCBs. The results showed that eating salmon from the commercial food supply (whether farmed or wild) does not pose a health risk to consumers.”

The UK Food Standards Agency has reported that the health benefits of eating moderate amounts of fish, including salmon, as part of a healthy balanced diet outweighed any potential risk from PCBs. Based on 21 surveys carried out by the Agency results found that exposure to these contaminants from the diet has fallen by about 75% between 1982 and 1997.

How has the U.S. federal government determined safe levels of PCBs in foods? “The FDA has set residue limits for PCBs in various foods to protect from harmful health effects. FDA required limits include 0.2 parts of PCBs per million parts (ppm) in infant and junior foods, 0.3 ppm in eggs, 1.5 ppm in milk and other dairy products (fat basis), 2 ppm in fish and shellfish (edible portions), and 3 ppm in poultry and red meat (fat basis).” Two ppm in fish is equivalent to 2,000 ppb (parts-per-billion) in fish. The fish oil products in question today contain less as a percentage by weight than is allowed even in baby food, and are taken in far smaller amounts by total weight per serving than whole fish. Yet these fish oils are now being targeted for added label warnings that they are known by the state of California to contain toxins with the false implication that these minute dietary amounts are proved to be harmful and should be avoided at all costs.

What are the alternatives? Apparently eating actual fish won’t do; they would be consumed at far larger serving weights and naturally contain far more PCBs than a serving of natural fish oil. Yes, some fish oils are highly purified, which is what the lawyers argue as a reasonable alternative to the natural oils. Yet there are legitimate critics who argue against chemically processing and refining natural food products such as this, even for reasons of purity. And some of the oils most likely to have accumulated PCBs are from long-lived fish which are higher in the ocean food chain and have been long valued as health foods with strong evidence of enhancing human health, like cod liver and salmon oils.

If we force all foods to either have disproportionally scary warnings or be processed out of their natural states, pushing only the least natural products as the “best” choices, this has serious implications for the nature of our food supply and how it impacts our nutritional status. We have seen degenerative disease rates soar as the amount of refined foods in the diet increases, and natural food advocates have long argued that we return to unrefined whole foods in order to naturally maintain health. This current fish oil scare is capable of needlessly frightening people away from taking safe healthy fish oils that could improve their health. That would be the real crime.

References:

Agency for Toxic Substances and Disease Registry (ATSDR). 2000. Toxicological profile for Polychlorinated Biphenyls (PCBs). Atlanta, GA: U.S. Department of Health and Human Services, Public Health Service. http://www.atsdr.cdc.gov/toxprofiles/phs17.html

Health Canada http://www.enotalone.com/article/10328.html

The UK Food Standards Agency

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

My response to Bill O’Reilly’s program “Suzanne Somers' 'No Spin' on Vitamins”

,On Friday, February 19, 2010, Bill O’Reilly discussed recent legislation introduced by Arizona Senator John McCain (the Dietary Supplement Safety Act; S.3002) to impose new regulations on dietary supplements (vitamins, etc.) with Suzanne Somers. He made several points that are quite reasonable: that there should be warnings on labels, that we should know what is in the products, that manufacturers should be registered with the FDA, that ingredients should be disclosed, and that the FDA should have recall authority. I heartily agree with these common sense statements but need to point out that these elements are already mandated by current federal regulations that simply may be inadequately enforced. As in other fields, a few shady operators ignore laws when profits can be made by cheating. The answer to the occasional scofflaw is strict enforcement of existing law; without enforcement, both current and new laws would be equally worthless. But Mr. McCain’s proposed new law will severely decimate law-abiding companies in a misguided effort to import an unpopular regulatory scheme from Canada that gives unelected government bureaucrats absolute power over already-regulated vitamin products. Canadians now cross the border to buy American vitamins 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 the required safety and efficacy documentation. Current laws can accomplish Mr. O’Reilly’s goals, if they are enforced. Dietary supplement manufacturers are already registered with the government, are already required to submit label claims to the FDA, are already prohibited from making medical claims for dietary supplements, and are already required to identity-test and list all ingredients on product labels. Ingredients that have been on the market for many years are already pre-approved by the FDA and all new ingredients must be specially pre-approved before going to market. All mislabeled products are considered adulterated and subject to mandatory recall. 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, This does not sound like an unregulated industry, even if enforcement can be improved in some areas. What we don’t want is the FDA, an agency that is cozy with pharmaceutical interests, to have complete power over every new vitamin formula that is merely a variation of already-approved ingredients. That kind of permanent government takeover will strangle an important health industry that in a free market added jobs and exports during the recession. Vitamins help Americans meet basic nutritional needs in a cost-effective manner without government funding and may have actually decreased some Medicare spending, according to the conclusions of authoritative Lewin Group reports. Understand and enforce the current laws before proposing a virtual federal takeover of an industry that is law-abiding, has welcomed recent regulations that have empowered federal authority over it, and would suffer great harm from a huge increase in unnecessary government interference. Think about it: If you were driving on the highway at 55 miles per hour and occasionally some jerk speeds by at 90, would dropping the speed limit to 45 correct the problem? Of course not. It obviously makes more sense to station additional cops along that stretch of highway to enforce current traffic laws than to collectively punish all drivers. Why is enforcement of vitamin laws any different? Target the outlaws, not the innocent! Neil E. Levin, CCN, DANLA www.honestnutrition.com

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