Monday, December 15, 2008

How to Determine Quality in Supplements, Part 3

Hopefully by this time I have already established in my first two posts on this subject that there are some serious problems in terms of quality in the supplement industry. To verify some of those assertions, consider the following list of just a few of the common problems that exist in dietary supplements:
  • Inaccurate label claims of herbal products. Monmaney T. Labels’ potency claims often inaccurate, analysis finds. Los Angeles Times, August 31, 1998.
  • Lactobacillus products mislabeled and contaminated. Hughes, et al. Microbiologic characteristics of Lactobacillus products used for colonization of the vagina. Obstet Gyneocol 1990;75:244.
  • Herbs seriously contaminated with heavy metals and pathogens. Bateman, J. Possible toxicity of herbal remedies. Scottish Med J 1998;4:7-15.
  • Nutrient interactions inhibit mineral absorption from multiple vitamin-mineral supplements. Shils, et al. Modern Nutrition in Health and Disease Vol 1.8th ed. Philadelphia: Lea & Febiger; 1997. pp. 216-217.
  • Calcium supplements contaminated with lead. Bourgoin B, et al. Lead Content in 70 Brands of Dietary Calcium Supplements. Amer J Pub.Hlth. August 1993, Vol. 83, No.8
  • Herbal weight loss products cause lethal side effects because of being tainted with dangerous drugs. August 2002, Media Inquiries: 301-827-6242
  • Herbs contaminated with mold. Halt M. Moulds and mycotoxins in herb tea and medicinal plants. Eur J Epidemiology 1998;14:269-74
  • Liver failure and serious liver injury occur with herbs contaminated with drugs. U. S. Food and Drug Administration Center for Food Safety and Applied Nutrition Office of Nutritional Products, Labeling, and Dietary Supplements November 19, 2001

So how can you know if a supplement company is in the health science business rather than in the business of selling pills? Here are some things to look for:

1. GMP certification. Like I mentioned in my first post, this is the ONLY way to know if a company is just tooting their own horn or if the quality of the company has been analyzed by a reputable third-party placing their stamp of approval on their manufacturing systems.

2. Assays. An assay is an analysis of finished products and their individual ingredients. Most companies do not perform assays because they are not required by the FDA and they are expensive. But this is the only way to tell if a batch is contaminated with mold, fungus, heavy metals, pharmaceutical agents, or other foreign substances. Many companies that do perform assays do them randomly, perhaps one batch out of every 10 or 20. However, responsible quality control demands that assays be performed on every batch because purity is not guaranteed with every batch of new raw material.

3. Human evaluations for safety and efficacy. Unfortunately, this is a rarity in the supplement industry. Most companies base the safety and efficacy of their products upon third-party research done on various individual ingredients, but they do not test the actual products themselves in a clinical setting. It cannot be assumed that just because the third-party research on Echinacea, for example, showed a certain degree of safety and efficacy does not mean that once the Echinacea is manufactured into a product in a particular facility that it is then going to pass stringent QC/QA measures and that it will have that same effect in the clinical setting. This is especially true when the ingredient is combined with other agents. Most third-party research is done on individual ingredients, not on combinations. So most supplement manufacturers produce products simply assuming that if the research on Echinacea shows benefit in immunity, and the research on Goldenseal shows similar benefit, then why not combine them for an even better result? While that works out sometimes, at other times ingredients can actually compete with one another and cancel each other out. So it is important that there be a system in place that provides human safety and efficacy studies on the finished products to be able to provide a high level of predictability.

4. Extensive scientific Team. Most companies, if they have scientists on staff at all, have maybe 2 or 3 overseeing the entire operation. I find it difficult to believe that 2 or 3 scientists, or even a half dozen, could efficiently oversee the formulation, manufacture, and testing of thousands of bottles per month of product while also keeping abreast of the latest research. I didn’t say it couldn’t be done. I just said I find it difficult to believe that it could be done efficiently. I tend to trust a broader range of expertise which incorporates botanists, professional wild crafters of herbs, PhDs, MDs, chiropractors, clinical nutritionists, and naturopaths all working together to pioneer breakthroughs in the nutritional industry, to produce nutriceuticals that pass the scrutiny of all the various disciplines involved, to stay abreast of all the latest research, and to oversee the operations. If I needed a heart operation, I would want at least two qualified heart surgeons on hand, several nurses, an anesthesiologist, etc, rather than trusting my health to just a couple of guys with stethoscopes. Nutritional products are no different. We take them into our bodies. They affect our biochemistry, and I want mine to be produced by the most extensive scientific team with the most years of experience possible.

5. State of the Art Facilities. This goes back to GMP certification. A manufacturer can throw a few scientific-sounding terms your way to make their operations sound impressive, but you really have no idea what their operations involve without a third-party analysis of their facility and operational system. I had one doctor tell me that he toured the facility of a doctor’s line supplement company who I will leave nameless, and he said that it really wasn’t anything more than a big dank warehouse with a few machines. And yet somehow they were still proud enough of the place to give tours of it. That’s not what you want to see from a supplement company, especially one that is marketing their goods to doctors.

6. Product Innovation. One of the elements that a sophisticated product line should possess is unique product innovation and industry firsts. A true science-based company that is helping to blaze new trails in nutritional medicine will invest in the process of scientific discovery and well-designed research to bring previously undiscovered compounds and new applications for already-known compounds to the market. Honestly, most nutritional companies even in the professional market are what I call “me too” companies, meaning that they piggy-back off the research and product innovation that other companies have already pioneered and create their own spin-off products with slight variations and cheaper price tags. In a free market system that is certainly a legitimate way to forge a business. However, if enough practitioners patronize me-too companies based upon getting what they hope will be the same kinds of products for less money, eventually all the companies who actually invest in research will no longer be in business, or at least not be able to do the research any longer.

As you can see, there is a lot to producing supplements that are of true quality, more than most people could ever imagine. Just looking at the ingredients on a label and checking to see if “quality” is somewhere in the marketing is not a good way to determine the quality of your supplements, and neither is looking for less expensive products necessarily. True quality costs money, and a more sophisticated line will usually reflect that in their prices. That is true of organic food, it’s true in the extent of training that certain doctors receive and the services they offer, it’s true in the automobile industry, it’s true in the clothing industry, and every industry under the sun. And it’s certainly true in the supplement industry. You get what you pay for, and when patients understand that they are more inclined to comply with the practitioner’s recommendations instead of going down to the local franchise pharmacy to purchase their supplements.

In conclusion, practitioners should help their patients understand the difference between companies that are in the health business and those that are in the business of selling pills. Those that are in the health business will adhere to the standards discussed in this and the previous posts, because as as Dr. Jeffrey Bland likes to say, “The most expensive supplement is the one that doesn’t work.”

Tuesday, December 9, 2008

How To Determine Quality in Supplements, Part 2

A good share of doctors who are evaluating a supplement line and/or a specific product do it like this: They will look at the label and check for certain ingredients. All done. If they like what they see in terms of ingredients, that is all they think they need to know.

Allow me ask this question: If a healthcare consumer were looking through the yellow pages for a good holistic practitioner, would you say that they have investigated their choices thoroughly by simply looking at the educational degrees of the various practitioners and the services offered? I think you would agree that just because someone has certain letters behind their name and offers a particular service does mean that their level of expertise is what you are after. I heard a joke that illustrates this point. “Do you know what you call a medical student who graduates with a C average? Answer: Doctor.”

I have been adjusted by chiropractors who I will never let touch me again, but others seem to have a magic touch. I have met self-proclaimed nutritional gurus who are so “out there” in their philosophies that I wonder how they ever got be doctors, but I would trust my own family to others. If you are like me, you don’t want just anyone with his/her name on a shingle adjusting your spine or overseeing your medical care.

Shouldn’t we be just as scrutinizing with the supplements that we are taking on a daily basis, and shouldn’t doctors be even more scrutinizing when it comes to supplements with which they trust their livelihoods?

If you believe that a supplement line merely calling themselves “professional” and talks quality and markets themselves to doctors automatically makes them a company turning a quality product, then I have some beachfront property in Kansas I would like to sell you. :-)

Everyone Talks Quality
When was the last time you saw an advertising line like this: “Our quality control is above average.” Never, right? Nearly every supplement manufacturer will provide you with full-color advertising showing people in white lab coats looking at samples in a test tube or through a microscope. Everyone says that they are second to none in terms of quality, just like every restaurant says that they maintain a clean kitchen, just like every car manufacturer wants you to believe that their brand of car is the safest and most reliable on the road, etc. So how do you differentiate effective marketing from true quality?

Unfortunately, there IS a big problem with quality in dietary supplements. Bear in mind that the supplement industry is not regulated by the FDA, and that means that standards of quality are self-imposed. In other words, it is up to each individual company how much money they want to spend on quality measures. And that is perhaps why there are not more companies that are GMP certified (see my last post).

There is much more to determining the quality of a product or supplement line than just looking at the ingredients of a label, because there are some serious problems that exist in the supplement industry regarding quality that I’ll talk more about in the next post. For today’s post, however, I want to focus on the difference between what’s on a label and what is actually represented in a product.

Analyzing Raw Materials
Nearly all supplement companies get their raw materials from third-party suppliers. Remember, there are no FDA standards to guide supplement companies in how they select their raw materials, so most of the time companies make their decisions based upon price and based upon the claims of the raw material suppliers. If the companies selecting these raw materials don’t analyze what they are buying prior to the purchase, then they really have no idea what they are getting.

For example, the therapeutic parts of the herb, Echinacea, are in the flowering bud, not the stem or the roots. Yet a supplement company can buy a batch of Echinacea from a third-party supplier not knowing that most of the raw material is stems and roots and possessing almost no therapeutic benefits.

Even the true therapeutic parts of the plants can vary from batch to batch, and that’s why comprehensive lab analysis are important to verify the different constituents of the plant.

The herb, St. John’s Wort, for example, contains hyperforin and hypericins that give the herb the therapeutic benefits. In a recent analysis of four different suppliers of St. John’s Wort, all varying in price, the lab analysis showed the following:

The first three samples, ranging in price from $12.32/kg to $19.00/kg, all had incomplete assay information and/or had incorrect assay methods. There was no detectable hyperforin in any of them, and although there were adequate levels of hypericins, all three samples had suspect adulteration with synthetic hypericin. All three samples also had heavy metal contamination.

In contrast, the fourth sample of St. John’s Wort – by far the most expensive of the four at $36.00/kg – was identity confirmed with a complete and correct assay method, had therapeutic amounts of hyperforin at 3.0%, and therapeutic amounts of natural, unadulterated hypericins at 0.3%. Likewise, there was not any heavy metal contamination.

A scrutinizing supplement company would know what to look for in all four samples, so they would first of all have to know what a correct and complete assay method looks like to be able to determine if the information presented in the assay report actually means anything. It’s not enough to just have an assay. You have to know the correct assay methods. Secondly, the scrutinizing company would know what levels of the therapeutic agents to look for, as well as levels and types of possible adulteration. Thus, a company that is truly in the health business will choose, in this case, sample #4 even though it is three times more expensive than some of the other samples.

As a last point, what do you think the suppliers of samples 1, 2, and 3 do after a company with high standards rejects their raw materials? You guessed it. They just take their shoddy raw material and go sell it to another supplement company who either doesn’t do any raw material analysis at all, or one who doesn’t perform the proper methods of evaluation.

So price is definitely not the way a responsible consumer, whether it be a practitioner or a patient, should be choosing their supplements.

In my last and final post on this subject, I’ll address six other markers of true quality in supplements. Stay tuned.

Tuesday, December 2, 2008

How to Identify a Quality Supplement Line

The food supplement industry is one of the fastest growing industries in America and abroad. It is little wonder that new supplement lines are sprouting up all over the place.

For scrutinizing practitioners who want and need to provide the absolute best for their patients, how does one wade through the marketing to determine quality that is worthy of the clinical setting?

As I embark upon this subject, let me say up front that you should not take my word for any of what I’m about to tell you. I have worked in the supplement industry for 15 years now and have been privy to information to which most practitioners are not exposed. But in that I could rightfully be accused of having biases because of my associations, I encourage you to check out my claims for yourself.

Good Manufacturing Practices (GMP)
One of the most important markers of quality in supplement manufacturing that a scrutinizing practitioner needs to know about is Good Manufacturing Practices (GMP). There are three entities that offer GMP certifications. They are the Natural Products Association (NPA), the Therapeutic Goods Association (TGA), and the National Sanitation Foundation (NSF). These organizations are reliable third-party sources of gold standard analysis on the quality of supplement manufacturing. Their analysis involves random audits that scrutinize areas that most practitioners would not even know to ask about, such as determining if the kind of paint used on the walls is producing off-gassing, whether or not the water is ultra-purified, analyzing the joining of walls to the floor to make sure that there is a gradual and sloped transition so that no dust can gather in the corners, analyzing the machinery and the operating systems, and testing the knowledge of the people running machines to make sure that each person’s procedures matches GMP standards.

This is merely a partial list, as a GMP audit usually takes up to two weeks to complete, and companies seeking GMP certification do not know when the audit is going to take place. The auditors simply show up unannounced, so the company had better be operating according to those standards 24/7 to score a passing grade.

The primary goal of GMP is to ensure that the manufacturing processes operate in a state of control. This state of control acts as a filter to help eliminate product contamination, mix-ups, and errors. GMP certification offers health professionals and their patients a basis for trust that the supplements they are using are safe and match label claim.

GMP is Good Business
GMP certification is good business for both the company in question and the doctors and patients using their products because it reduces exposure to potential product liability issues. Remember, in today’s culture anyone can sue anyone for almost anything. If a patient ever sought legal actions against a doctor for his or her administration of a certain nutritional product, the backing of GMP certification that is consistent with how drug companies manufacture their products could help protect both the doctor and the supplement company.

Also, GMP certification reduces exposure to regulatory enforcement actions.

I have included the GMP framework at the end of this post for those interested in learning more.

Aren't All Supplement Lines Operating with High Standards?
It takes multiple millions of dollars to get a manufacturing system and facility up to the very stringent GMP standards, but the certification itself costs only $200. Many companies claim that they are “GMP compliant,” or “operate according to GMP standards,” but these claim beg an important question. If a company has already spent the millions of dollars it takes to get up to GMP standards, why would they not spend another $200 to validate their quality claims by getting certified? As it appears to me (for whatever my opinion is worth), the companies who are not certified remain that way because either they know up front that they cannot pass the audits, or because they have already attempted to get certified but failed the stringent auditing process.

As it currently stands, there are only two doctor’s lines that maintain GMP status, and there is still only one doctor’s line that is certified on all three levels.

Yeah, but…
One common argument against GMP certification used by non-GMP companies is that the GMP process doesn’t take into consideration ingredient selection. In other words, an aspirin or calcium carbonate product can be GMP certified. So ingredient selection and product design certainly play an important role.

I agree that GMP is not an all-encompassing standard of what differentiates a quality line from those that are not. However, GMP is like a doctor who has a certified degree offering treatment versus someone like myself who has some knowledge of healthcare but has no license. A scrutinizing patient would and should raise an eyebrow at a person who said, “Well, I have all the knowledge that any other practitioner has, I just never got my license. But you can trust me because I offer the same care that any licensed practitioner would.” In order to validate the knowledge, training, and skill of any person offering healthcare, a license or certification must be in hand.

Similarly, a scrutinizing practitioner should also raise an eyebrow at a company who claims to operate according to GMP standards but never bothered to get certified. A product line can be making great choices in terms of their ingredient selection but then fail in other vital quality procedures. What good is the best Ginko raw material, for example, if the manufacturing process fails in many important markers of quality determined by the GMP certification process? If a company will not invest the $200 it takes to get GMP certified, then it should not be assumed that that company is operating on that level of quality in spite of what they claim. Nor should it be assumed that that company is doing the due diligence in other areas of quality not analyzed by GMP.

Remember, every supplement company is in business to make money, and talk is cheap. A practitioner really has no idea what goes on behind closed doors unless the system in place is analyzed, scrutinized, and certified by a reliable and recognized third-party placing their stamp of approval on the operating system. And that’s why GMP is important.

In the next post, I’ll address a few other important determinants of quality.


The GMP framework involves:
Technical Controls
Operational Controls
Relational Controls
-People (Employees and Suppliers)

GMP controls include the use of procedures that control each step and records that confirm procedures were followed and provide traceability in the following areas:
· Receipt and storage of raw materials, in-process materials and finished product.
· Manufacturing process
· Testing (raw materials, in-process and finished product)
· Filling, labeling and packaging
· Finished product approval
· Document Review
· Release and distribution
· Change control