Supplements in America

Over the past 70 years, vitamins and other supplements have been widely recommended by nutritionists, chiropractors, naturopathic doctors and most alternative medicine practitioners without evidence of efficacy or safety.  Many fashion, social, and health magazines and articles routinely make proclamations about the value of supplements as a way of life, frequently the more the better.  The manufacturers of supplements do not perform scientific experiments to validate their hyped claims, preferring to simply make claims based on petri dish, molecular, or rat studies, then dangerously extrapolate those results to human health.  They may take one isolated study and extoll the virtues of a specific supplement when there may be 10 other studies that contradict them.  Because they lack the understanding of scientific method to prove or disprove a claim, are incapable of performing statistical analysis, and fail to recognize the difference between theoretical vs. clinical outcomes, these journals and practitioners have made claims that are actually quite false at best, and at worst have caused disease and death through their unjustified recommendations.  Harvard Medical School has evaluated the claims regarding supplements over time, and found most were lacking in truth in advertising. 

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Problems with the Supplement Industry

The supplement industry is fraught with many problems:

• Inadequate Federal laws regulating supplements

• No approval required by the FDA prior to marketing some products and only minimal documentation for all others

• Outrageous health claims that are frequently not borne out by studies- claims that are illegal under federal law

• Poor quality assurance with many products adulterated with prescription drugs or OTC drugs illegally, failure to contain the active ingredient on the label or in the amount labeled, containing unlabeled fillers dangerous to some people, unintentional adulteration with toxic drugs during manufacturing, manufacturers usually do not analyze the raw materials or chemicals used to make up their products

• Claims that their products are “natural” when in fact the product may not be found anywhere in nature, or are manufactured chemicals that have the same structure as those derived from foods. 

 

 

More than 50% of Americans use dietary supplements (NCHS Data Brief April 2011) and believe supplements are safe with have few side effects compared to pharmaceutical drugs.  But supplements may not be as safe as generally perceived as shown in the following examples:

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John twists his back at work (factory job) and was out for 3 days with a backache so severe he could not sleep or barely walk across the room.  The pain was not any better so he decided to take something more than the acetaminophen he had tried without success.  He has arthritis but could not take NSAIDs due to a past history of a bleeding ulcer.   He reads on the internet turmeric, cinnamon, fish oil, MSM, glucosamine, and ginger all have some pain killing properties and hears of combination pills.  After buying a combination pill with all these ingredients, he took the pill and within one hour was feeling much better, and was able to go to work the next day. Other than some nausea, he didn’t have any side effects- at first.  However after about 3 days he began vomiting blood, and went to the ER.  He denied taking any NSAIDs but the bleeding became rapidly worse, with an emergency surgery required, but it was too late.  John died, the pathologist conducting the autopsy found no prescription drugs in his system, and no reason he should have bled so severely.  The pathologist did not test for the over the counter drugs naproxen sodium, aspirin, and ibuprofen, that were present in the combination supplement pill unbeknownst to John and the pathologist.  Only a year later did the FDA require its removal from the market when random testing showed very high levels of the three drugs above plus the prescription NSAIDS diclofenac and indomethacin- effectively five different NSAIDs that were no where on the label.   John never knew he was taking a combination of prescription and non-prescription drugs because the supplement manufacturer failed to label the contents properly, because if they had, the FDA would not allow them to market the supplement.  Instead of a safe alternative for arthritis the supplement was actually a mixture of deadly drugs to John that ultimately led to his demise.  The pathologist and coroner did not report he died because of the supplement because they did not know it contained prescription drugs known to cause gastric bleeding.  The FDA did not receive a report about the death.  The manufacturer of the supplement was not notified about the death by the supplement since no one recognized the supplement was adulterated.  There was no recall of the supplement that continued to be sold on the shelves of pharmacies and grocery stores until a year later.  The family was left without an explanation as to why their otherwise healthy husband and father with a tweaked back would suddenly bleed to death.

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REGULATION OF SUPPLEMENTS

 

This example of what happened reveals a very nasty fact about the supplement industry:  supplements are not regulated the same way as are drugs, devices, foods, or biologics by the FDA under current law.  In the 1930s-90s, supplements largely consisted of vitamins and minerals with few herbs sold as viable treatments.  Supplements at that time were directly obtained from foods or herbs.  Congress showed little interest in regulating the industry until the early 1990s when the FDA proposed regulations that would have treated supplements like drugs.  Because of the tryptophan supplement disaster in 1993 resulting in 38 deaths and 1,510 cases of eosinophilia (elevation in a type of the white blood cells) with sharp muscle pain,  fatigue, fever, and rashes, the FDA proposed regulations to protect the public.  However the industry fought back against the FDA.  The supplement industry championed by Orrin Hatch, a US senator from Utah ultimately blocked the FDA from regulating supplements by passing a law in 1994, the Dietary Supplement Health and Education Act of 1994 (DSHEA).  This law actually drastically expanded the definition of supplements and offered protections from FDA scrutiny as long as the supplement contained at least one of the following: “(1) a vitamin, (2) a mineral, (3) an herb or botanical, (4) an amino acid, (5) a dietary substance "for use to supplement the diet by increasing total dietary intake," or (6) any concentrate, metabolite, constituent, extract, or combination of any of the aforementioned ingredients.”  The expansion allowed supplement manufacturers to not only manufacture the active ingredient as chemicals (no longer directly obtained from foods or herbs) but also allowed the manufacture of chemicals and drugs not found in foods (any metabolite of the supplement that could occur in the body can now be manufactured as a supplement.  Hormones, previously not available as supplements, are now available as supplements.  So much for the “all natural” claims that have misled so many people for decades.  Orrin Hatch has continued to block regulation of the supplement industry for over two decades in Congress and his family, friends, and business associates have become fabulously wealthy in the supplement industry. Hatch has since stated “I am committed to protect this industry” and stated about his family’s supplement business and his intervention in Congress: “I do whatever they ask me to do many times because they’ve never asked me to do anything that is improper”.   

 

The DSHEA made it impossible for the FDA to proactively require the same safety and quality measures that are required for pharmaceuticals. DSHEA limits FDA authority by:

• Preventing FDA approval of supplements

• Not allowing the FDA to require premarketing certification of contents

• Not allowing the FDA to enter or survey the manufacturing facilities before marketing of a supplement

• Prevents the FDA from pre-emptively requiring any studies to support their claims about their product

• Not requiring warnings about who should not take the supplement, any side effects or adverse affects reported or possible from the supplement

• Relegates the FDA to doing their own testing of products randomly rather than requiring testing by the companies making the products

• The FDA can take action against the company by requiring recalls of products only if there is FDA demonstrated prescription drugs or unlabeled contents or unapproved chemicals in the supplement

• The FDA can shut down a manufacturer only through court order and after multiple infractions

 

The FDA does have the authority to prevent claims on supplement labels about healing properties of supplements with respect to diseases or cures but the supplement industry widely disregards or engages in subterfuge to get around this limitation.  For instance, the use of the words “supports” prostate or heart health is used without qualification.  The industry is allowed to make health claims linking a supplement to a disease cannot contain the words “cure” or “heals” or have a supplement that is named to indicate curing or healing.  However printed literature  supplied by the distributor or the store’s website serve to amplify the claims, and supplement books sold in nutrition stores are used to provide references for consumers to use.  Manufacturers are also allowed structure/function claims in which a supplement is permitted to make claims about how a supplement affects organ function or structure if followed by the disclaimer   “This statement has not been evaluated by the U.S. Food and Drug Administration (FDA). This product is not intended to diagnose, treat, cure, or prevent any disease.”

 

 

The FDA is always playing catch up with monitoring the over 70,000 supplement products on the market, performing random testing of products.  If a product is mislabeled or has unapproved chemicals that are not related to a food or metabolite of a food or amino acid or herb, then the FDA sends out warning letters, and may order a recall.  But the supplement manufacturers simply change the name of a product and continue selling it with the adulterated components.  It is very much like the game “Whack a mole” in which the FDA is trying to stamp out misbranding in an industry that is out of control. 

 

So how bad is it???

The federal government filed more than 100 criminal and civil cases against supplement manufacturers in November 2015, heralding a new era in what was previously a relatively feckless approach to supplement manufacturers.  The court cases were filed by the FDA, FTC, US Postal Inspection Service, and the IRS in 18 states.  The basis of the litigation is against adulteration with unlisted ingredients and products making unsubstantiated health claims.  Some of the claims found supplement manufacturers imported ingredients from China with falsified analysis, falsified labeling of supplements, and lied about it to the government when it was discovered an illegal synthetic stimulant was being added to the supplements unbeknownst to the public.  One manufacturer was cited by the FDA for causing liver injuries from its supplement and stated they would stop selling it, but then unloaded all their remaining inventory onto the market.  Another company sold MSM claiming it was a treatment for Alzheimer’s disease and cancer without any proof, while another company sold a DMSO roll on as a treatment for cancer.   Many companies were sued by the federal government for false claims or adulteration with illegal additives, some of which were prescription drugs taken off the market due to injuries and organ damage.  Some supplement manufacturers had concocted fake scientific studies to coerce the public into buying their drugs.   http://consumerist.com/2015/11/17/feds-file-criminal-civil-cases-against-more-than-100-supplement-companies/

 

The FDA does not release the statistics on the extent of misbranding/mislabeling/adulterated contents/lack of stated contents so it is difficult to derive meaningful information on the extent of the industry problems.

However, the FDA does publish some of its warning letters sent to manufacturers located at: http://www.fda.gov/ForConsumers/ProtectYourself/HealthFraud/ucm255474.htm

In 2017, the FDA issued 82 warning letters including adulteration of products, misbranding, and unapproved new drug introductions

In 2016, there were 87 warning letters to supplement companies for adulteration of products, misbranding, and unapproved new drug introductions 

In 2015 the FDA issued 72 warning letters including adulteration of products, misbranding, and unapproved new drug introductions. 

In 2014 there were 67 warning letters issued for the entire year.  Each warning letter may affect multiple products of a company or affect other companies since some companies buy the finished product of a company and rebrand it as their own.  Many of these warning letters were for false claims, misbranding, or the introduction of an unapproved drug. 

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Supplements Do Not Necessarily Contain What They Say They Do

 

The FDA also issues recalls of supplements.  A list of some of the recalls for 2014 is found here:  http://www.fda.gov/forconsumers/protectyourself/healthfraud/ucm432969.htm

 Many of the recalls involve arthritis, weight loss, or sexual health supplements that are adulterated with prescription drugs- in many cases several prescription drugs.  This is illegal under federal law.  Many of the sexual health supplements contain Viagra or Cialis, drugs that can be fatal to individuals with heart or blood pressure issues.  Many of the dietary supplements contain prescription drugs that have been previously removed from the market by the FDA due to safety issues.  The supplement manufacturers intentionally and illegally adulterate their otherwise worthless products with prescription drugs, some of which are unsafe.   Some of the recalls are of supplements found to contain drugs that have never been approved in the US and are certainly not part of a metabolite of a food or herb.  For example, Pro ArthMax was recalled as part of a FDA fraud case in January 2014 after it was discovered via analysis that it contained 4 different NSAIDs and 2 central muscle relaxants, one of which was not an approved drug in the US.   

 

The FTC (Federal Trade Commission) is now getting involved with the most egregious cases of outrageous claims made by supplement manufacturers for false advertising.  This occurred in November 2015 when the FTC launched action against Sunrise Nutraceuticals of Boca Raton Florida claiming their dietary supplement Elimidrol, “a proprietary blend” of herbs and other compounds “alleviates opiate withdrawal symptoms and increases a user’s likelihood of overcoming opiate addiction.  The company claimed it is the only “opiate withdrawal product guaranteed to work, that it is non-addictive, and will help users “permanently overcome withdrawal- the first time” and that “the effects can be felt from the first dose”.  The FTC has also launched deceptive advertising lawsuits and sent warning letters to over 20 companies that sell online supplements for weight loss.

 

Consumerlabs.com is an independent testing agency that frequently finds problems, some severe, in an average of 1/3 of products randomly chosen for testing.  Some of these problems include findings of insect parts in some products (e.g. turmeric) and extreme variations in the amount of product compared to the labels.  Some products such as fish oil was found to contain PCBs. 

 

In 2015, the New York State Attorney General launched an investigation into supplements and had his own testing performed on the DNA of herbal supplements sold by GNC, Walmart, and several other major companies.  In many cases, the product did not contain any of the product that was on the label, instead containing rice, mustard, wheat, and radish instead of the Ginkgo biloba that was on the label.  Walmart Spring Valley Echinacea had absolutely no Echinacea in the bottle when independently tested.  Only 21% of the herbal supplements contained the DNA of what herb was listed on the label.

 

Canadian researchers (In a New York Times story Nov 3, 2013) tested 44 bottles of popular supplements sold by 12 companies.  In 1/3, there was not a trace of what was touted on the bottle, and in most others, there was contamination with other products or ingredients.  Only 2 out of 10 companies products had accurate labeling of contents.  Indeed the labeled contents of these supplements are fraudulent and misleading in the majority of products tested. 

 

Another study looked at dietary supplements on the market and found one quarter had unlabeled NSAIDs present in significant quantities (Food Addit Contam Part A Chem Anal Control Expo Risk Assess  2014;31(6):973-8). 

 

In 2010, sibutramine was banned in the US markets due to complications from using the medication.  In 2014,  there were 52 weight loss supplements obtained from the internet and tested (non were labeled to contain sibutramine) and half of these supplements contained sibutramine with some capsules containing up to 35mg  (Food Addit. Contam Part A Chem nal Control Expo Risk Assess 2014;31(1):p15-20).  There is no reason to believe there is not a major industry-wide deception based on these studies.

So hopefully, in the absence of the FDA regulation, the states may take action against the manufacturers for committing fraud, but this is a long-term legal process for each supplement targeted by the state.  Since manufacturers can simply make up a new supplement overnight, it is unlikely states can react quickly enough to curtail fraud.

 

"Shelly Burgess of the FDA said in a New York Times article November 2013 that approximately 70% of supplement manufacturers are operating outside of good manufacturing practices that were designed to prevent product adulteration of supplements."

 

“Dietary supplements accounted for more than half of Food and Drug Administration (FDA) Class I drug recalls between 2004 and 2012”  Forbes Apr 18, 2013 David DiSalvo

 

SUPPLEMENT SAFETY

            Supplements may or may not be safe.  We have an unregulated industry that may or may not be lacing their product with prescription drugs, untested chemicals, fillers, or may contain none of the actual product listed on the label, so it is difficult to draw any conclusions about the safety of supplements given the variability of what they contain.  However researchers published a study on Oct 15, 2015 in the New England Journal of Medicine that calculated there are 23,000 emergency room visits nationwide due to adverse events related to supplements.  Nearly 10% of these resulted in hospitalization. Weight loss supplements were implicated in 25% and increased energy supplements were implicated in 10%.    An Oct 2014 (page 1399) publication in Hepatology found there were 130 patients among 8 referral centers that developed toxicity to the liver from dietary supplements.  Of these 130 patients, 45 developed liver injury due to body building supplements and 85 by non body building supplements. The percentage caused by dietary supplements (compared to other causes including conventional drugs) increased from 7% to 20% between 2004 and 2013.   A Salt Lake Tribune report May 19, 2015 linked several military deaths to supplements sold on military bases, some of which had been recalled by the FDA due to illegally containing unlabeled prescription drugs.  Many supplements continue to contain DMAA in 2013-15 after it was banned by the FDA in 2012 after 6 known deaths and over 100 reports of sickness.   A study in Finland found that for people between ages 62 and 74, over a 10 year period 26.6% of those taking supplements or vitamins died whereas 18.1% of non users of vitamins or supplements died.  When taking into account other factors such as age, gender, and smoking, the researchers found those taking vitamins or supplements were 50-70% more likely to die than those not taking supplements. (livescience.com Mar 12, 2012).

            There have been many reports in the medical literature of toxicity associated with supplement use.  N.O.Explode caused renal failure in a soldier (J Am Board Fam Med 2014 Jul-Aug:p565).  Peripheral neuropathy has occurred due to arsenic toxicity from contaminated supplements (Ann Clin Biochem 2013 Sep:p496).  There are many reports of vitamin D toxicity (J Pediatr Endocrinol Metab 2014Jul:p763) including renal failure (Food Chem Toxicol 2012 Jun;50(6):2106-8), (J Bras Nefrol 2011 Dec:33(4):467-71), (Rev Med Liege 2015Jan:p12).  Some dietary supplements are toxic due to very high concentrations and mislabeling of contents such as Soladek that in analysis contained very high 864,000IU/ml  Vit D3 instead of the labeled 600,000 IU /ml Vit D   (J Clin Endocrinol Metab 2011 Feb;96(2);291-5).  Excessive oral calcium has caused pancreatitis (Ann R Coll Surg Eng 2014 Jan;96(1);94E).  Ulcerative colitis occurred with use of the herbal weight loss supplement Hydroxycut (BMJ Case Rep 2013 Jan 3:2013).  A case of acute kidney and liver injury were reported after ingestion of Tribulus terrestris, a herb used by body builders (Clin Nephrol 2015 Mar;83(3):177-83).   Garcinia cambogia has been reported to induce serotonin toxicity (J Med Toxicol 2014 Dec;10(4):399-401).  Black cohosh has been reported to cause liver failure in two patients (Exp Mol Pathol 2014 Jun;96(3):279-83).   Kava kava has been linked to  4 deaths and 11 cases of hepatic failure leading to liver transplants, and 78 cases of hepatotoxicity. (Toxicol Lett 150(1):85-96).   Caffeine as a supplement has been linked to more than one death including one person that took 12g of pure anhydrous caffeine, equivalent to 100 cups of coffee (Am J Forensic Med Pathol 2013 Dec; 34(4):321-4).

In a study of adverse events from herbal medicines from 1998 to 2009 in a pharmacovigilance database, it was determined there were 627 adverse events with the liver involved as the main organ in serious cases, with 22 deaths reported (Clin Toxicol (Phila) 2012 Jul:50(6):481-9).  Since the FDA has no equivalent database, it is not possible to determine toxicity or deaths from supplements in the US.

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SUPPLEMENT-DRUG INTERACTIONS

See the link here for more information about interactions

 

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