Let’s talk about supplement quality. This is a big and important issue to me because it directly impacts my practice and my clients on a day-to-day basis.
First, a couple headlines caught my eye in the news a few weeks back:
Amazon, EPA reach $1.2 million settlement over online sales of illegal pesticides
Apparently, “over the past five years Amazon committed nearly 4,000 violations of the Federal Insecticide, Fungicide and Rodenticide Act by allowing third-parties to sell and distribute imported pesticide products from Amazon warehouses even though the pesticides were not licensed for sale in the United States.”
And:
Popular goods sold through Amazon, Walmart and others are counterfeits: Government report
The conclusion we can draw is basically this: Just because something is sold on a well-known website doesn’t mean that it’s safe, legal, or authentic.
In the second story, a Federal investigation found that a whopping 43% of popular items purchased through Amazon, Walmart, eBay, Sears Marketplace, and Newegg websites were counterfeit.
We like to think we can tell the difference. Maybe we should just avoid buying products coming from China (after all, earlier estimations found that 25% of Amazon’s marketplace is composed of Chinese counterfeiters). Or we’ll only purchase products with good reviews and excellent customer ratings. This should indicate quality and authenticity, right? Unfortunately, no:
“All 47 items purchased were advertised as new, brand-name items sold by third-party sellers with average customer ratings above 90 percent, and all items were shipped from U.S. addresses.“
In this investigation, none of the purchased products were supplements (which were not within the purview of the investigation), but it is still an instructive example.
The counterfeit supplement market is a huge and well-oiled machine. Counterfeit supplements are commonly reported by manufacturers and quality is not guaranteed or easily discerned. Some research discovered that one in three supplements analyzed were fake, and the rest were low quality and contaminated. Outright fraud, breaches of contract, and gross inconsistencies have been documented by myself and other practitioners. I’ve seen this firsthand several times from clients who have ordered from Amazon and received what was obviously the wrong product (e.g. one time something arrived in tablets but it is actually only manufactured in capsules — everything else about the bottle appeared authentic!). Others have gotten bottles that were opened, partially empty, or even completely empty in one case. In most instances, however, you would never know the difference by appearance. This problem is pervasive, and I have personally participated in shutting down some of these illegitimate and/or counterfeit sellers.
Another thing you commonly find online is the public sale of professional brands on places like Amazon, eBay, Pure Formulas, Professional Supplement Center, etc. Most professional brands are not allowed to be sold on third-party sites without the involvement of a healthcare practitioner, yet this happens frequently due to contract violations or through the production of counterfeit products. Labels, barcodes, size, texture, color, taste, etc. can all be immaculately reproduced by a good counterfeiter, and it is a billions-per-year industry.
Many professional manufacturers have gone to great lengths to prevent pirated and/or counterfeit sales and to maintain product authenticity and traceability. Sophisticated forms of 2D (matrix) barcodes have been developed, but even this hasn’t stopped counterfeiters, who often employ very clever countermeasures. The one exception to this would by Xymogen, who is years ahead of the curve in employing advanced tracing and anti-counterfeiting technology that has more or less successfully eradicated illegitimate sales of their brand.
Professional Exclusivity and Contract Violations
As healthcare professionals, in order to distribute these brands in our practices, we are often required to sign a contractual agreement stating that we will never sell these products online through Amazon or any other public website. For example, see the Biotics Research contract here, which states in part:
The products manufactured by Biotics Research Corporation (“Biotics”) and sold by Biotics or Biotics’ distributors (“Biotics Distributors”) are made available for sale to consumers solely through healthcare professionals (“Healthcare Professionals”). Unrestricted sale of Biotics’ products over the Internet by a healthcare professional does not afford the protection of the consumer that Biotics expects from healthcare professionals utilizing Biotics’ products…
What are the repercussions for an account that is in violation to Biotics’ policy?
Formal written notification will be issued stipulating the violation must be rectified and fully compliant within a ten (10) day period. If compliance is not met within the ten (10) day period the account will be suspended and/or terminated.
Biotics clearly states that their products are only to be sold through healthcare professionals. They also disallow healthcare professionals from selling their products online unless they are selling to their own clients through a password-protected website.
Even so, large online stores such as Pure Formulas and Professional Supplement Center brazenly display Biotics and many other contractually-restricted brands right on their front pages in blatant violation of these companies’ Internet reseller policies.
Do you see why this is so bothersome? Because in order to do this, they have to get their supplies from somewhere. So either:
1) Healthcare professionals are signing up with the professional brands, signing the contracts (they are required to do this), and then reselling the supplements to the big online stores (or selling them on Amazon themselves). This obviously violates the contractual agreement and is incredibly sleazy. It also prevents 100% traceability, and this is sometimes where contamination, dilution, improper product handling/storage, or product expiration occurs.
2) Outright counterfeiting is happening. This happens frequently on Amazon. Copycat products with similar or identical labels are manufactured and sold at a steep discount. Dr. Nicole DiNezza gives a great example of an obviously counterfeit product being sold with the Biotics label:
It looks real! It is even “Fulfilled by Amazon” and ships from Amazon warehouses complete with Prime shipping! But as Dr. DiNezza points out, a 500-tablet/bottle option for this product (Beta Plus) does not exist! It is manufactured only in bottles of 90 or 180 tablets (for $17.50 and $30.90, respectively — nothing for $87.50) Such a blatant mistake is a bit humorous, but what’s not funny is that this kind of counterfeiting absolutely infests the online marketplace but is hardly ever this obvious.
The Beginnings of “Supplement-Suspicion”
Early in my practice (almost 10 years ago), I didn’t sell supplements. Regular discount supplements looked good and saved clients money, while “professional brand” supplements (supplements that are sold only through healthcare practitioners) often appeared similar but were more expensive. I usually just wrote down some recommendations and referred clients to online stores to find the products. But over the years, I gradually transitioned to using mostly professionally-branded supplements. Inconsistencies started showing up in some of the discount supplements. I remember several people taking vitamin D softgels from Walgreens in the Nature Made brand. Blood testing showed no increase in vitamin D blood levels even after months of supplementation. This same thing occurred in several of Dr. William Davis’ patients. When I and other practitioners contacted Nature Made about this issue, they insisted that the product was genuine, even though lab testing repeatedly showed that it had no effect on vitamin D blood levels. When the brand was switched, blood levels went up as we would expect. This happened again and again. Nature Made has also had issues with their fish oil. While the amount of fish oil on the label appears to be accurate, some of their products have been found to contain toxic PCBs and high levels of rancidity.
I’m picking on Nature Made, here, because it’s a very common brand in grocery stores and pharmacies, and it was influential in providing a wake-up call for me to be more critical in my approach to supplements. While naturopathy is largely a “diet-and-lifestyle” modality, supplements can be and usually are important tools for improving wellness. And why would we expect great outcomes if we’re using mediocre or ineffectual (or worse, harmful) interventions to achieve those outcomes?
Over time, I discovered that Nature Made wasn’t the only questionable brand. And some brands were good overall, but then the quality was inconsistent. Vitacost is a good example of this. Vitacost has some decent low-cost basic supplements and pretty good (though rudimentary) quality standards. But they can be erratic, self-contradictory, and (I hate to say it) untrustworthy. For example, Vitacost claims to believe in GMO transparency, yet I have a customer service representative on record telling me that the manufacturing department “is pretty certain” that their phosphatidylcholine supplement contains GMOs. But this is not stated anywhere on the product information page or the product label.
Vitacost customer service also told me at one point that their low-cost pine bark extract supplement was the patented Pycnogenol® pine bark extract. This was false. Pycnogenol® is not listed anywhere on the label or product page, and the polyphenol content is completely different from that of genuine Pycnogenol® by around 30%.
Other discount supplement stores like Swanson Vitamins have some of the same weaknesses. Like Vitacost, I think Swanson has pretty good quality standards overall, but they are not impeccably thorough in their quality control and some significant sloppiness has been known to occur. Take their Traditional Red Yeast Rice, for example. While it is listed under the category of “Cholesterol Support,” independent testing demonstrated that it contained zero monacolins (the major cholesterol-reducing component). Moreover, it tested extremely high in citrinin, a toxic fungal metabolite that is linked to kidney damage. The amount of citrinin in a daily was up to 28 times higher than the average daily intake of citrinin in healthy individuals. Granted, the product does not claim to be “citrinin-free” or to have a particular level of monacolins. But no one should be selling a high-citrinin product (for example, if a product was found to be loaded with lead, we should be free to complain about this even if the label does not specify “lead-free”). Quality-control should be testing and catching these things. I sure wouldn’t want to be taking a “cholesterol support” product that does nothing for my cholesterol and potentially damages my kidneys in the process.
Again, the supplement industry, in general, is poorly regulated and label claims frequently fall short of reality. Even big-name brick-and-mortar stores (e.g. Walmart, Walgreens, Target, and even GNC) frequently carry supplements that either contain no active ingredients, or worse, contain harmful ingredients.
Professional Brands Go the Extra Mile
For these reasons and more, I largely switched over to using professional brands in my practice. Professional brands can be more expensive than these other discount supplements, but I’m convinced the price is worth it for the assurance of good quality. If I’m working with a client and I’m having a poor outcome, I don’t want to have to wonder if it’s because the supplement I’m using is real or not, or potent enough, or contaminated, or whatever. I shouldn’t have to worry about that part of things. I can get an independent certificate of analysis (COA) for any of these professional products showing both purity and label accuracy. Compare this to an experience recently when I merely asked to see a COA on some turmeric from a discount manufacturer and customer service wrote back to tell me that they were shutting down my account! (even though I didn’t even have an account– ha!) This is probably an extreme example, but the point is that there is a whole different level of quality and transparency when it comes to professional brands vs discount over-the-counter type brands. Many more quality-assurance steps are taken to ensure accuracy and purity. This is the kind of reliability I want when it matters (which is every time I administer a protocol).
To give you an idea of the quality-control that goes into the brands I use, here are the standards that are required in order to be a “gold partner” professional brand in one of my primary professional dispensaries:
- Acceptable supplier and contract brand qualification consisting of: demonstrated cGMP compliance as well as regular on-site audits or established historical relationship. Further, certificate of analyses for Raw Materials and Finished Products are initially validated by conducting full confirmation testing on several subsequent receipts.
- SOP demonstration of controlled manufacturing processes for all Finished Products and cGMP processes
- Specifications for all Raw Material and Finished Products and documented usage of these specifications
- Use of most appropriate testing methodologies when testing for identity, microbiologicals, heavy metals, pesticides/herbicides (for botanicals), aflatoxins (when applicable), melamine (when applicable), and residual solvents
- Raw Material testing on each batch or at a frequency justified with written rationale inclusive of: In addition to supplier Certificate of Analysis, identity is tested on each batch of raw materials or finished product and all other analytical tests (microbiology, heavy metals, pesticides/herbicides (non-organic), solvents (concentrates), and adulterants are completed on at least every 5th batch/lot, or if less than 5 lots, at least once annually. Each ingredient (or product) must be tested according to an established risk-based testing program.
- Re-qualification of Contract Brands by questionnaire and/or site audit at least every 3 years
- Potency testing procedure for finished products in place and in use.
- Evident industry knowledge of common adulterants and contaminants, and sufficient testing to guarantee the absence of these adulterants and contaminants in finished products and disqualification of suppliers of adulterated ingredients.
- Analytical testing on each batch of Raw Material or Finished Product for: identity, potency (label claim) and microbiological contaminants as well as all other applicable analytical tests on ingredients at risk for certain impurities (e.g. solvents for concentrates, pesticides for non-organics, melamine for animal proteins, aflatoxin for high risk herbs/foods, adulterants).
- A real time stability program is in use to ensure that all finished products meet label claim throughout shelf life.
- Products contain active ingredients in sufficient quantities to be clinically effective
- Evidence of Total Quality (such as: Research & product development, sustainable environmental practices, clinical trial support, good business practices).
Just for the sake of comparison, Vitacost fulfills only one quality-assurance standard from the above list (cGMP-compliance with COA). It’s definitely a good thing to be cGMP-compliant (this should be a given for any supplement brand under consideration), but as you can see it’s not nearly as thorough as it could be in terms quality-assurance. Again, I think Vitacost (and Swanson, etc.) is OK for some things (it’s a case-by-case situation) and I’m not saying that every product sold outside of the professional sphere is bad. There are even good and legitimate supplements sold on Amazon by some sellers and manufacturers (though it can be hard to tell!). But when quality counts every single time I’m much more comfortable relying on professional brands for my routine recommendations and protocols.
In my practice, I supply supplements to my clients by 1) ordering on their behalf through a verified professional dispensary or from the manufacturer, or 2) allow them to set up a personal account with one of my dispensaries (or in some cases through the manufacturer directly) so they can make their own orders and legitimately have access to otherwise-restricted professional brands.
Professional supplement dispensaries acquire their inventory directly from the manufacturers and employ stringent quality-control practices, as detailed above.
Stay safe out there as you shop online! Purchase your supplements from your trusted practitioner or from another trusted and verified source. Your health and the health of your family is too important to take any chances.
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