Consumers, Supplements and Confusion!
By Dr. Alan Kadish NMD
As the press has increased the drum beats to convince the public that the supplement industry is in need of a takeover by the FDA, some discussion of the issues is very much in order.
Is there a perfect storm of consumers experiencing confusion over their supplements or is this the manipulation of truths by the media ?
Are you purchasing a quality vitamin or mineral product? In this confusing world of supplements there are many firms with incredible claims and conflicting materials. Unfortunately there is no real safeguard to insure that your purchase is indeed reflective of the company’s claims, with some caveats.
The FDA has jurisdiction but is limited to removal only of a product that has been shown to present an imminent danger to the public or the firm is not following good manufacturing practices or is making unlawful claims. Not unlike the jurisdiction over pharmaceutical products. This is a two bladed sword, please read on….
As a consumer it always pays to take the time to evaluate the claims and carefully determine your best course of action. The newest, best and most potent product seem to be the catchwords of this industry. Many companies make thinly veiled claim for all sorts of maladies. Becoming a critical consumer is essential. Review the material presented and remain objective.
Remember that Aunt Martha’s lumbago many have little resemblance to your sciatica, although it may sound great for an advertisement.
The majority of supplement purveyors are very ethical and generally aware of the many aspects of the industry rules and follow the law.
Where to Start:
You can begin your evaluation of a product by carefully reading the literature provided. Is there some scientific referenced materials or only testimonials present ? Are their sales techniques consisting of quoting scientific sounding publications, but with no way to follow the trail , with published references ? Or are they making up new terms that sound scientific ?
One of the most prevalent deceptive practices is to base their claims on other product results. Let me explain. Most supplement manufacturers do not engage in scientific studies of their combined finished products. Many of the supplement product suppliers and manufacturers do however engage in good research.
They may spend years perfecting a single ingredient, which is then sold in bulk to many supplement manufacturers to either be sold individually or in a multiple item supplement. The typical ingredient will be patented and will have notation made on the ingredients listing or on the label indicating its origin.
Obviously there is a cost issue with any study, however there are a number of excellent firms that do indeed fund studies of their products, to both make certain that they have quality results and are safe at the levels suggested. A industry trade magazine, Nutraceutical World has a significant amount of cutting edge information on these studies and who internationally are making major changes in ingredients and medical implications.
If the literature supplied does not indicate the product advertised is the product used in the study, forget the claims and look elsewhere. You have NO assurance that this substitution will be effective. The only exception would be to meet the exact specification of the product/s being tested. Many times this can not be done as the method of preparation or the compound is proprietary hence it’s protected by patents, and only substitutes are being offered.
You can go to the internet where you can directly access a supplement manufacturers site and get extensive information regarding many of the aspects of the ingredient. One of the other considerations that often times is lost in translation is the necessity to have a substantial amount of the active ingredients present to duplicate a actual study findings. I can’t emphasize adequately the nonsense that is seen when the label is long and impressive, but the contents are only trace amounts.
The second most deceptive issue is the use of an association claiming to be a “certifying” organization. Their certification can be anything from a monetary payment to a real evaluation. This form of an “assurance” can be completely without merit. Many of the certifications are made by the manufacturers.
There are legitimate groups, however some are costly to the manufacturer and clearly not accessible to smaller organizations. The cost of one of the largest “testing” groups is based on a per product fee and can run into the thousands of dollars for each item. As an example we should consider the USP (United States Pharmacopea), and the NSF (National Sanitation Foundation). Products that meet these standards are allowed to use a corresponding logo on the label.
A completely different approach is via a large wholesaler who has unique criteria and then carries corresponding products. The EQP (Emerson Quality Program) evaluates products based on product design, manufacturing controls, raw ingredient and finished product testing.
Clearly the FDA has taken the side of the pharmaceutical industry and not placed your safety first. Remember that the terms Natural and Hypoallergenic are meaningless. Everything is natural and there are no limits on its use in advertisements. Hypoallergenic simply means that a less allergenic format was used. The problem with this is that there are no clear definitions as to what agents meet this definition. These are but two of the many examples commonly found on many labels.
Now for some good news: The CGMP’s ( Current Good Manufacturing Practices were implemented over a three year period starting in 2007 and inclusive of all manufacturers by August of 2010.“Under the final rule, manufacturers are required to evaluate the identity, purity, strength, and composition of their dietary supplements. If dietary supplements contain contaminants or do not contain the dietary ingredient they are represented to contain, FDA would consider those products to be adulterated or misbranded.”
As a consumer this is really an excellent step to insure your safety and also to insure you’re getting your moneys worth. The 815 page monster is worth a quick scan. Seriously there are so many aspects to manufacturing of a supplements that most consumer never recognize. For the full implementation information go to CFR # 21 parts 110-111. The gist of the legislation is that companies must follow minimum manufacturing, packaging, labeling and quality control to sell their products.
Keep in mind that MANY of the current firms have been in compliance with the pharmaceutical requirements, a much more stringent level, for years. So one of the big questions you might ask is who are these firms? I found that primarily they are the supplement manufacturers, exclusive to physicians.
Of course you might conclude , unfairly, that this would inevitably increase the price. Generally speaking this is not true. Quality products are not necessarily more expensive. We found that at our clinic and at some e-commerce sites the price tends to be 5-10% less than typical retail levels. With the following information you can start to make some significantly better choices in supplements.
What should a consumer ask of any supplement?
(1) What form are the supplements ?
A pill, capsule, powder, liquid or gel cap.
For Pills: What binders, coloring agents, lubricants and/or fillers are present? There are a number of questions raised about the use of tablets by capsule manufacturers. However, newer information seems to refute their contentions. The minimum amount of excipients seems appropriate, coupled with 3rd party dissolution testing. This should insure similarities between delivery, from both tablets and capsules.
For Capsules: are they vegetable or animal based. Unfortunately some of the vegetable based capsules are not appropriate, as they contain lauryl sulfate and propylgylcol in their manufacture. A proprietary product, vegicaps is completely natural and contains no adverse ingredients. A number of supplement manufacturers are in the process of changing to vegicaps because of the BSE (mad cow disease) scare.
For Powders: Consider how the product will remain fresh. Whti the amount of oxygen exposure to an open container this becomes an issue quickly unless it’s a mineral compound exclusively. The B group of vitamins and all of the oils will experience issues over time, including taste, texture, color changes due to oxidation of the product.
Single dose packaging is one way to avoid the problems , inclusion of a good amount of antioxidants or the use of specific capsulation technology of the products during manufacturing, can be adequate solutions. If they used a coating technology would allow for a film like coating that prevents the oxygen from reaching the product. The powder will not necessarily look any different to the eye.
For Liquids: what oils or other agents are present as carriers? Avoid any that contain cottonseed oil or waxes. Is sugar or some form of sugars used?
For herbs: Is it standardized? This means that the active ingredient is found in each dose identically. Has the herb been checked for contaminants? This would include heavy metals, pesticides and herbicides. Is the correct herb used? You would be dismayed to learn of the number of substitutions that take place. Good firms always check the genus and species of their products. This is not required with the supplement level of GMP. (see below)
(2) Does the manufacturer adhere to Good Manufacturing Processes at the pharmaceutical, not food requirements level ?
There is a clear set of rules for what is referred to as the cGMP for supplements. All supplements companies are required to meet these standards. There is a second GMP for pharmaceutical firms, that is much more intensive. Only some supplement manufacturers voluntarily adhere to this pharmaceutical cGMP approach.
Only a few top quality supplement manufactures go the extra distance to also check for solvent residues a big consideration in the herbal lines as many of the active ingredients are isolated and then reintroduced to increase the active ingredients, artificially.
(3) What is the correct dose of the supplement or herbal product and does this reflect scientific data or just a guess by the manufacturer?
(4) What potential side effects have been noted ?
(5) Are there any known supplement-drug interactions ?
(6) Do they cover the product with a money back guarantee ? Dose: Let’s consider doses. The RDA’s are meaningless. Follow this logic. The intent of the RDA’s is to protect you from the common diseases that occur from lack of a minimum intake of vitamins and minerals. The subjects used for these studies are assumed to be “healthy” individuals. Forgive my sarcasm but when did you last see someone who had scurvy or was perfectly healthy ? Statistically the RDA’s only apply to ~ 5 percent of the population. There are limits to the appropriate amounts of nutrients that should be consumed.
By careful evaluation you can safely determine your optimal levels. New available methods of testing, which we have been doing with our patients for the last 10+ years, give use the information needed to determine optimal individual nutrient levels.
There have been a number of sensationalized warnings regarding many of the natural food supplements. Overwhelmingly these tend to be gross exaggerations and have very minimal and in some case no scientific basis. In the changing environment of the public’s acceptance of more natural approaches to health care, the entrenched pharmaceutical industry is losing millions to those consumers who choose to use supplements.
Over the last 15 years most of the large pharmaceutical groups have entered the supplement marketplace with both over the counter and “prescription” natural products. Consider that we now have both probiotic and fish oils in prescription format….at high prices.
Fear tactics are very successful even when no substantiation is indicated. There have been side effects and other adverse events using principally herbal and contaminated products.
However when statistically taken as a whole compared to prescription medications we are looking at a very low incidence rate and not comparable to the multitude of contaminated “fake” drugs in use or the many prescriptions that have been pulled from the marketplace, after multiple deaths.
Do problems in the industry still exist, absolutely. In the herbal realm the increase in products from overseas sources is a constant issue, for all of manufacturers. The more recent overviews of Chinese medicines in 2008 and the crackdowns in China in 2012 was more than another wake up call for practitioners.
Approximately 2/3 of the imported products checked in 2008 were adulterated with both prescription drugs or toxic metals. Current estimates are that 60% of herbal products are imported from China.
In our practice at the Center we exclusively used only 2 American supplement firms who purchased Chinese herbs, tested the raw materials and then went on to manufacture the supplement, if and only if they met strict standards.
In speaking to their buying agent it’s obvious that the unscrupulous use of contaminated products continues. They reject large amounts of herbal products regularly, which are then sold to those companies whose standards are less than stellar.
To modulate the concern that the herbal industry is fraught with issues, let’s turn our attention to manufacturers of herbal products in the US. Of particular note is an Oregon firm, HerbPham which has been engaged in good QC and uses organically certified products, as much as possible, since the 1990’s well before the regulations. This is not an exclusive situation. Many of the best growers have expanded exponentially as consumers recognized that quality and significant levels of active ingredients, are very desirable.
You might be interested to know that currently approximately 60% of all prescriptive products are of natural origin or relation.
Most consumers don’t realize that many of our top US universities are actively involved in the evaluation and application of many natural products. There are university websites such as those from the Institute for Natural Products Research, , INPART, NPDI and of course our local Linus Pauling Institute at Oregon State University. This is a small example of both excellent reference sites and ongoing research.
Good Industry studies, but another example of being Demonized:
An excellent example of a product that competed with a number of prescriptions was the Pharmanex product, Cholestin™ used to decrease cholesterol. Made from red yeast rice it contained trace amounts of lovastatin, naturally occurring, along with other statin like products. After 34 double blind studies, with 1100+ participants it had not one significant elevation of liver enzymes.
Contrast this with the popular Lipitor™ , Mevacor™ and Pravacol™ , which require liver test before and during use, because of the potential harm to your liver and the many liver enzyme elevations and other side effects.
In the comparison of the studies, the results show superior effect from the natural product, Cholestin™ vs. the pharmaceutical products and it was consistently less expensive.
But “the American Heart Association issued a statement “urging caution when using Cholestin. This was done because there is no reliable information about Cholestin’s long-term safety or effectiveness.” “They went on to add, therefore, people may be venturing into the unknown by using the substance in much higher amounts than were used in Chinese cooking,” says Pearson. In addition, although Cholestin is less expensive than some of the prescription drugs, many health care plans do cover statin drugs, but will not cover dietary supplements.”
REALLY…… I’m certain you understand the fact that this supplement was taking market share from the pharmaceutical manufacturers. This is the perfect example of the bait and switch maneuver used to discredit legitimate firms and use organizations that appear objective.
I would counter that the extensive and long term use of Cholestin, which is NO LONGER AVAILABLE as the parent firm went bankrupt, due to the cost to defend themselves in court. The statin manufacturer spent millions to claim it was a drug, not due to any adverse events and won.
If shopping for supplements is overwhelming, seek out professional advice. Your conventional practitioners (MD/ DO/NP) will not be intimately familiar with most supplements or herbal products, with minor exceptions. Currently, in 2014 (I update for 2018 no real changes) only a few medical schools teach “alternative” or “integrative” medical subjects. To be knowledgeable with these products requires significant time and study, not cursory familiarity.
As our population increases and supplement and herbal sales follow, the “typical” number of prescriptions per patient is also increasing. It becomes that much more urgent that your care provider be up to date and really familiar with the products, not just having taken a few courses or read a book or two.
Although there is a plethora of information on the internet, use the same care that would be prudent for any other medium when researching. Remember to check if the sites are offering educational materials only, preferably without any product sales.
The conflicting information deluge will be with us for some time. New and exciting findings regarding very powerful natural agents is an emerging field that will benefit us all.
There are many times that it is essential to use a pharmaceutical product. However in my practice, I employ the best of both worlds with a concentration on the least harmful and most effective method, before resorting to pharmaceutical products.
Check for Interactions:
As a consumer, there are a number of sites on the internet that offer the consumer an easy way to double check if you’re potentially at risk of experiencing a drug-herb interaction. Two guides to consider are those at: Medscapes or WebMd . Always make a practice of checking your list of supplements and prescriptions for interactions. Bring this information to your physician and ask questions. Most interactions are not of concern but use common sense.
Quality vs. Cost:
Purchasing inexpensive vitamins is wasteful, however good quality need not be overwhelmingly expensive. There are a number of ingredients in that are simply expensive. You will note that in many formulas, the manufacturer only places an insignificant amount, with the intention of making their product appear “complete”. The result is a long list of insignificant components. Remember, if the claims sound too good to be true, it probably is.
As a quick example of a good sounding but not good substitution is the B-12 in your supplement. The least expensive is cyanocobalamin, but for the most effect one would want the methylcobalamin form. The difference is in the price…… and substantial when you consider the difference from a physiological point of getting your monies worth.
Let’s look at another common bait and switch. The absorption of magnesium oxide is fractional (~18%) vs the 3 or 4 other forms that are commercially available and range in absorption between (~85-90+%). Remember it’s not what you take but rather what goes into your cells that count…..
We appreciate that this article should be a start of your considerations when evaluating supplements and herbal products. The overwhelming literature support, for most of supplements, is constantly being updated. Please follow our blogs as they are updated constantly.
As a discriminating consumer you can make major changes in your health quotient, safely.
Copyright Center of Health™ 10/2007, updated 1/2014/8 For permission to reprint this article, please contact the author.
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