Rebuttal to recent general media articles “Skip the Supplements” and “Herbal Supplements Are Often Not What They Seem”.
Ashleigh Gass, MS, CSCS, CISSN, CCN, CNS.
Recent media articles “Skip the Supplements” and “Herbal Supplements Are Often Not What They Seem” caught my attention and inspired this rebuttal. Even though some of the information presented in these articles was correct, we weren’t given any information about the other side of the story. This is significant - because the other side of the story would have given consumers an opportunity to learn about hundreds of excellent nutritional supplement companies and their respective products. Yet again, the general public was left flapping in the breeze of misleading, incomplete nutrition articles geared towards “poo-poo-ing” the nutritional supplement industry.
Perhaps these articles were written with the intention to “protect” the public from purchasing supplements from certain companies, or to discourage people from taking nutritional supplements in general. If the former is correct, the articles would have had far greater value if they’d pointed out the many companies following stringent manufacturing practices. If the latter is correct and the articles were written to dissuade people from taking nutritional supplements in general, well, once again, specifics would have been beneficial. As opposed to painting the entire supplement industry, and supplements in general, with the same brush, clarification should have been made to differentiate legit companies from those not willing to follow manufacturing guidelines, and clinically effective supplements vs. supplements without an effective track record.
Part of the problem with these articles is that they lead to massive confusion among the already nutritionally confused general public. Even worse, what if patients receiving effective nutritional therapy from medical nutritionists, DOs, NDs, or MDs specializing in nutritional medicine become scared of their treatment protocols as a result of reading these articles? When confusion dominates, people generally reach a stand-still on that topic and do nothing, or, even worse, quit the entire thing.
Much of the confusion could have been dodged if these articles had been titled “Skip the Non-CGMP Compliant Supplements (Current Good Manufacturing Practices), or “Herbal Supplements are Often Not What They Seem When You Don’t Know What You’re Talking About”, or “Seek professional guidance when choosing supplements” or “Research highlight on supplements that work and the companies that make them”. At the very least, these articles would have been useful had they:
a. Educated the public about FDA-approved CGMPs, FDA-approved manufacturing facilities, and the various independent organizations that certify nutritional supplements;
b. Educated the public about various companies that follow the same, strict manufacturing standards found within pharmaceutical companies;
c. Educated the public about which supplements to skip, exactly;
d. Educated the public about which herbal supplements aren’t what they seem;
e. Provided appropriate resources for the public to search for companies following a, and b; and
f. Provided insight into nutritional supplements that have been proven beneficial for specific health conditions.
However, none of the above points were covered in any way, or even alluded to. Thus, we were left with a few more unhelpful, one-sided, confusing nutritional supplement articles.
My intention with this article is to give you, the consumer, correct information to think with when choosing nutritional supplements, and a few resources to research if you have a health condition you think may respond well to the assistance of nutritional supplementation. My disclaimer is as follows: personally, and professionally, I follow, and teach “food comes first”. With every client under my guidance, I work with their MD to improve various markers found in their blood work, mostly with the implementation of new food rules. Clients learn to cook and store abundant amounts of vegetables, meats, and seafoods. They learn the basic principles of nutrient timing, and the use of training/nutritional supplements deemed necessary. Key supplements are usually magnesium, fish oil, vitamin D, probiotics, and amino acids. Additional supplements are used and prescribed by the MD or RD based on symptom profile and/or lab results.
Now, let’s get started.
Part One: What are “Current Good Manufacturing Practices”, and how do we know whether a company follows them? Are there other regulatory agencies within the supplement industry?
According to the FDA, Good Manufacturing Practices are defined as:
“The Dietary Supplement (DS) CGMP (Current Good Manufacturing Practices) rule in 21 CFR part 111 (“the DS CGMP rule”) requires persons who manufacture, package, label, or hold a dietary supplement to establish and follow current good manufacturing practice to ensure the quality of the dietary supplement and to ensure that the dietary supplement is packaged and labeled as specified in the master manufacturing record”.
In short, CGMPs are a set of rules some companies voluntarily follow in the manufacturing process to ensure all raw materials used are high quality, and high purity. These rules are followed to make sure you, the consumer, are protected, and that your products have been tested for safety, and purity. When a company follows these rules, additional product tests include those for potency, purity, disintegration, weight, hardness, thickness, and stability.
Within CGMPs, there are several additional, independent organizations that offer quality testing and allow products that pass these tests to display their seals of approval. These seals of approval provide assurance that the product was properly manufactured, contains the ingredients listed on the label, and does not contain harmful levels of contaminants. Organizations that offer this quality testing include:
- U.S. Pharmacopeia (www.usp.org/dietary-supplements/overview)
- ConsumerLab.com (www.consumerlab.com)
- NSF International (www.nsf.com)
Notice the emphasis on some companies voluntarily follow. In the $28 billion supplement industry, made up of ~450 U.S. companies, about 70% don’t follow these regulations. F.D.A resources are limited, thus making enforcement a challenging process.
The articles were both correct in stating:
“The F.D.A requires that companies test the products they sell to make sure that they are safe. But the system essentially operates on the honor code” .
and
“The Food and Drug Administration doesn’t regulate dietary supplements as drugs - they aren’t tested for safety and efficacy before they’re sold. Many aren’t made according to minimal standards of manufacturing, and many are mislabeled, accidentally or intentionally. They aren’t often what they say they are”.
Thankfully, many companies do follow CGMPs, and voluntarily register with one, or all of the organizations listed above. These organizations are recognized by regulatory agencies at the local, state, federal and international level, and certification demonstrates that a product complies with all standard requirements. Nutritional companies who register with these organizations are subject to periodic facility audits and product testing to verify that their products continue to comply with the standards.
When a nutritional supplement company follows these guidelines, it means that the final product complies with specific standards for safety, quality or performance. Reviews typically include comprehensive formulation/material reviews, testing and facility inspections. Most certified products bear the certifier’s mark on their packaging to help consumers and other buyers make educated purchasing decisions.
When you buy supplements from companies who follow GMPs and are registered with NSF, U.S. Pharmacopeia, and/or ConsumerLab.com, you know your supplements aren’t “powdered rice and weeds”, or “contaminated with feces and urine”, or “found to contain anabolic steroids” - seriously? By gosh, I knew there was something in that protein powder from grass-fed cows I’ve been using lately.
Look for logos like these on supplement containers/bottles:
Logical next questions would be:
1. Why do some companies choose to follow CGMPs, while others do not; and
2. Which companies follow CGMPs.
It boils down to finances and ethics, basically. Ethical companies with strong financial backing care about product quality and consumer success. They follow CGMP guidelines. There are significant costs associated with “doing it right”, which can be broken down into “fixed” and “variable” costs. Fixed costs include variables such as quality control for maintaining quality procedures and implementation, and training staff to ensure exact oversight and implementation. Variable costs include the testing of raw materials for purity, potency, authenticity, microbial load, etc, and validation of certificates of analysis for all raw materials used. These fixed and variable costs will run anywhere from small millions to large millions - depending on the size of the company. Thus, financial backing has a great deal to do with whether a company follows all the appropriate guidelines. But, when they do, they:
1. Demonstrate compliance with national or international standards and regulations;
2. Demonstrate independent validation and verification of their commitment to safety and quality;
3. Increase credibility and acceptance with retailers, consumers and regulators; and
4. Benefit from enhanced product quality and safety.
What was conveniently left out of these articles was any mention of third party certification organizations such as the NSF, AOAC, and appropriate resources readers could access to determine safe supplement companies to buy from. There are hundreds of companies that DO follow GMP’s, that DO carry with them a Certificate of Analysis (C.O.A), assuring us that what’s written on the label is what’s in the bottle.
A list of 286 companies who follow NSF guidelines can be found here.
Professionally, I am a member of ARIIX International’s Scientific Advisory Board. We develop science-based products with the intention of improving people’s health. ARIIX is compliant with all CGMPs, in addition to being compliant with the AOAC (Association of Analytical Communities), the USP (United States Pharmacopeia), the FDA (Food and Drug Association), and USDA (U.S. Department of Agriculture) and the EPA (Environmental Protection Agency). And yes, it costs MILLIONS of dollars to adhere to all these regulations.
Part Two: “Approximately 50,000 adverse reactions to dietary supplements occur every year, and yet few consumers know this”.
Really? What, like loose stools secondary to high-dose vitamin C consumption, or the occasional niacin flush? Reality check - not one of the hundreds of consumers I’ve worked with had any idea that their antacid drugs completely shut down hydrochloric acid secretion by the stomach. Instead they’ve been left wondering why their mid-section resembles that of a bloated jelly donut, and embarrassed because they fart constantly. See, when you take antacids long-term, you impair digestion. The gateway to bloating, SIBO (Small Intestinal Bacterial Overgrowth), constant farting and blubber tummy opens wide.
They were also entirely unaware that the statin medications they were finger-wagged into taking blocked Coenzyme Q10 production (big problem - more on this later).
I suppose the estimated 700,000 people who end up in emergency rooms due to adverse drug reactions is totally acceptable though, right? I mean, why settle for 50,000 adverse reactions when you could knock it out of the park with 700,000.
Properly prescribed/administered drugs cause about 106,000 deaths annually, making them the 4th leading cause of death in the U.S. The opioid pain medication Vicodin, and the stimulant Adderall deserve special pats on the back - they are in the top 5 most commonly abused prescription drugs by teens. Straight off of The National Institute on Drug Abuse statistics page.
For another layer of fun here, let’s take a look at several defects in nutrient absorption induced by really common medications:
Antacids (medications to ‘treat’ acid reflux) inhibit the absorption of folate, riboflavin, calcium, iron, zinc, folate, vitamin B12 and vitamin D. Because these medications actually inhibit nutrient absorption by suppressing stomach acid production, they are now being linked to degenerative conditions such as osteopenia, osteoporosis, and macular degeneration (to name a few). The Journal of the American Medical Association (JAMA) published a study demonstrating strong associations between stomach-acid suppressing medications and overgrowth of a potentially serious intestinal micro-organism called clostridium difficile. Bloated mid-section and chronic diarrhea, anyone?.
The ever-popular cholesterol medications contribute to disease in their own special way. They prevent important enzymes from making Coenzyme Q10 (one of the most important antioxidants used by the heart, and for cellular energy production in general), and interfere with vitamin A, D, E and B12 absorption. These drugs also interfere with digestion and absorption of fatty acids, which we know to be critical in the health and maintenance of the nervous system. Cholesterol medication as the “one and only”, knee-jerk reaction to ‘treating high cholesterol’ makes as much sense as cutting off your hand to make a hangnail stop bleeding.
Weight loss medications really deserve the adverse reaction gold star. Do you also think we should “Skip the Supplements”, say, fish oil, or L-carnitine, for example, in favor of Qsymia? Qsymia, a popular prescription weight loss medication, is a nice little stack of phentermine and topiramate. It’s made clear on Qsymia’s website that:
“the precise mechanism of action of the 2 ingredients on chronic weight management is unknown”,
and -
“Qsymia is a federally controlled substance (CIV) because it contains phentermine and can be abused or lead to drug dependence”.
In contrast, not only do we know the (many) fat mobilizing mechanisms of action behind fish oil and L-carnitine, we know that both are fairly impossible to abuse or become dependent on. Interestingly, I started working with another weight-loss client 3 weeks ago. On day 2, she runs into my office, dropping her prescription Qsymia on my desk. I’ll never forget her exact words:
“My doctor gave me these to try lose weight, they make me feel crazy. I’m giving these to you to throw away, it’s terrible stuff and I don’t want it in my home”.
I saved them for the next outrageous house party. Just kidding.
She’s since lost 15lbs, with clean eating and by-gosh, nutritional supplements. Fish oil, magnesium, vitamin D, and amino acids, specifically. Her blood glucose levels have dropped down into non-diabetic ranges for the first time in 6 years. Shucks!
Part 3: Many health conditions respond brilliantly to specific nutritional supplement intervention, and research does prove it.
The often used stance of “you get everything you need from your diet” assumes that people eat an abundance of nutrient-dense foods every single day. Those of us who work with people and actually see what they eat know this is a total joke. Step one is ALWAYS to help them improve food quality - but even then, most people benefit from supplementation. As mentioned above, the top picks are usually magnesium, fish oil, vitamin D, and training supplements such as creatine and branched chain amino acids (BCAAs).
Perhaps forgotten, perhaps conveniently tucked away, was the 2002 article published in the prestigious Journal of the American Medical Association: Vitamins for chronic disease prevention in adults: clinical applications. This article clearly states that suboptimal intake of some vitamins is a risk factor for chronic diseases and common in the general publication, especially the elderly. Among their conclusions, authors state:
“most people do not consume an optimal amount of all vitamins by diet alone. Pending strong evidence of effectiveness from randomized trials, it appears prudent for all adults to take vitamin supplements”.
Paragraph one in “Skip the Supplements” cautiously ridicules St. John’s wort and probiotics by stating:
“Parents whose children are admitted to our hospital occasionally bring along something extra to help with their care: dietary supplements, like St. John’s wort to ameliorate mild depression or probiotics for better health”.
Please, allow me to insert a few key points you seem to have overlooked.
Probiotics have become well-respected for their role in the restoration and maintenance of healthy gut bacteria (referred to as the gut ‘flora’). This article, published in the Journal of Neurogastroenterology and Motility, titled “Irritable Bowel Syndrome, Gut Microbiota and Probiotics” (2011) states:
“In recent years, numerous studies have been conducted to understand the pathogenesis and treatment of IBS. However, IBS remains one of the most difficult GI disorders to manage regardless of its benign nature. Recommending probiotics has long been an alternative to the conventional medicine for the treatment of many diseases and is an attractive treatment modality for IBS considering its low costs and favorable safety profiles. In the context of dysbiosis as the pathogenesis of IBS, probiotic treatment seems reasonable and possibly ideal as it restores the intestinal microbiota. Many studies have indicated that probiotics might play important roles in maintaining gut homeostasis by the modulation of immunity and increasing epithelial barrier function. Clinical studies and systemic meta-analyses have shown that some strains of probiotics have beneficial effects in selected patients.”
Another study, published in the Journal of Alimentary and Pharmacological Therapeutics, September 2005, titled “A probiotic mixture alleviates symptoms in irritable bowel syndrome patients: a controlled 6-month intervention” made some helpful conclusions about a probiotic mixture used. This double-blind, placebo controlled study (considered the gold standard in medical studies) tracked 103 subjects over a 6-month period. Those in the probiotic group experienced a 42% reduction in symptoms. The authors concluded:
“the results indicate that this probiotic mixture is effective in alleviating irritable bowel syndrome symptoms. Considering the high prevalence of irritable bowel syndrome and the lack of effective therapies, even a slight reduction in symptoms could have positive public health consequences”.
I’m just getting warmed up here, folks.
St. John’s Wort has been used for thousands of years as a mild antidepressant. St. John’s Wort, an herb called Hypericum perforatum, contains hyperforin, which is a serotonin reuptake inhibitor. Hyperforin crosses the blood-brain barrier, and appears to be responsible for the antidepressant activity of the herb.
“Herbal Supplements Are Often Not What They Seem”, you say? Correct - they are often times much more than they seem. Several easily found studies on PubMed (a database of medical studies, supported by the US National Library of Medicine National Institutes of Health) makes this abundantly clear:
Study 1: Phytotherapy Research, July 2013 “Hypericum perforatum: Pharmacokinetic, Mechanism of Action, Tolerability, and Clinical Drug-Drug Interactions”:
“Hypericum perforatum (HP) belongs to the Hypericaceae family and is one of the oldest used and most extensively investigated medicinal herbs. Various clinical trials have shown that HP has a comparable antidepressant efficacy as some currently used antidepressant drugs in the treatment of mild/moderate depression. Interestingly, low-hyperforin-content preparations are effective in the treatment of depression. Moreover, HP is also used to treat certain forms of anxiety.”
The second easily found article, (published in CNS Drugs, 2003) written by German Researcher, Butterweck, at The Institute of Pharmacology and Toxicology, brings further clarity to the use of St. John’s Wort:
“Extracts of Hypericum perforatum L. (St John's wort) are now successfully competing for status as a standard antidepressant therapy. Because of this, great effort has been devoted to identifying the active antidepressant compounds in the extract. From a phytochemical point of view, St John's wort is one of the best-investigated medicinal plants.”
He further states:
“recent neuroendocrine studies suggest that St John's wort is involved in the regulation of genes that control hypothalamic-pituitary-adrenal axis function. With regard to the antidepressant effects of St John's wort extract, many of the pharmacological activities appear to be attributable to the naphthodianthrone hypericin, the phloroglucinol derivative hyperforin and several flavonoids. This review integrates new findings of possible mechanisms that may underlie the antidepressant action of St John's wort and its active constituents with a large body of existing literature”.
So folks, would you prefer guidance from a professional on the use of medicinal herbs and nutritional supplements, or, be put on Zoloft, add ten pounds of weight (the average weight gain quoted on the official Zoloft website) with possible “chances of suicidal tendencies, agitation, hallucinations, coma, overactive reflexes, high or low blood pressure, nausea, vomiting, rash, hives, joint pain, swelling of the face, tongue, eyes or mouth, headache, or decreased ability to make decisions”?
On a Friday night, overactive reflexes may come in handy but I’ll pass on the rest and opt for the “often not what they seem” herbal supplements.
I’ve just clipped the tip of the iceberg here, without going into a shred of the literature on sports nutrition supplements such as creatine, branched chain amino acids, beta-alanine, glutamine, or protein. I figure it’ll all end up in another article - this one’s already 8 pages and counting!
To wrap this up, please follow these guidelines when choosing nutritional supplements:
1. If you’re buying OTC (over-the-counter) supplements, make sure the company follows CGMPs. It won’t be hard to determine this.
2. If you are wanting to treat a specific set of symptoms or suspect you’re sick, work with a functional medicine doctor, a good RD, or medical nutritionist, etc. Objective tests can determine a great deal, after which you can take professional-grade nutritional supplements without worrying about quality.
Hopefully, to you, the general public, this article has served it’s purpose and given you useful information towards your search for health, and the use of high-quality supplements. To the supplement industry, I hope it’ll help you defend your rights to make high-quality supplements that help people.
References and resources used for this article:
Dial S, Delaney JA, Barkun AN, Suissa S. "Use of gastric acid-suppressive agents and the risk of community-acquired Clostridium difficile-associated disease." JAMA 2005 Dec 21;294(23):2989-95.
Aliment Pharmacol Ther. 2005 Sep 1;22(5):387-94.
A probiotic mixture alleviates symptoms in irritable bowel syndrome patients: a controlled 6-month intervention.
Kajander K, Hatakka K, Poussa T, Färkkilä M, Korpela R.
Age and Antacids: A Double Whammy Against Your Body’s Optimal Health.
http://www.ahha.org/antacidsarticle.htm
Mechanism of action of St. John’s wort in depression: what is known?
http://www.ncbi.nlm.nih.gov/pubmed/12775192
Vitamins for chronic disease prevention in adults: clinical applications.
http://www.ncbi.nlm.nih.gov/pubmed/12069676
Retail Prescriptioin Drugs Filled at Pharmacies (Annual per Capita by Age). The Henry J.Kaiser Family Foundation.
http://kff.org/other/state-indicator/retail-rx-drugs-by-age/
Zoloft.
Office of Dietary Supplements: National Institutes of Health.
http://ods.od.nih.gov/HealthInformation/DS_WhatYouNeedToKnow.aspx
National Institute on Drug Abuse: The Science of Drug Abuse & Addiction.
http://www.drugabuse.gov/publications/drugfacts/high-school-youth-trends
FDA: Dietary Supplements.
http://www.fda.gov/food/dietarysupplements/
Qsymia.