Saturday, July 25, 2009

Is what's on the label really in your supplement?

Most of us into health and nutrition dabble in supplements. Some whey protein here; a vitamin D capsule, maybe some fish oil, there. We do this because we believe what we've read about these things being a good idea. But what if what's on the label isn't what's in the tin? How do we really know we're getting what's promised by the label?
At the recent Z-Health 9S:sustenance course, overviewed here, we talked a lot about supplements: about what ones are worth taking, yes, but also about where to source them, once you've made the decision to use them. Based on that discussion, i did some further digging. It's not a story with a happy ending. Sorta more like left who's on stage at the end of Richard III: oh goodie the exciting, poetic, smart villain is dead, while this cheating asshole is left to run the kingdom but at least no one will be fighting anymore. hoo frickin' rah.

So this post presents a brief overview of legislation in the US around dietary supplements, problems with supplement quality and contamination, what good manufacturing practice (aka cGMP is) what third party certification like Consumer Labs or USP does with GMP (overivewed, anyway), a glimpse at the EU situation, and why June2010 is not the end of the War of the Roses.

History and Current Unregulated Practice. In the US, since 1994, there's been no requirement to have the Food and Drug Administration (FDA) assess either what goes into supplements or how they're made. Indeed, the FDA explicitly does NOT certify supplements (the way it does drugs and biologics). As its own web site says:
FDA does not approve dietary supplements.
Unlike new drugs, dietary supplements are not reviewed and approved by FDA based on their safety and effectiveness. Most dietary supplements that contain a new dietary ingredient (a dietary ingredient not marketed in the United States before October 15, 1994) require a notification to FDA 75 days before marketing.

The notification must include the information that was the manufacturer or distributor's basis for concluding that the dietary supplement will reasonably be expected to be safe. After dietary supplements are on the market, FDA evaluates their safety through research and adverse event monitoring.
Why might such oversight at the level of the FDA be important? Well, our fave sup companies might not be delivering the goods. Consider this story from June this year on a test of various supplements:
Potency problems
In testing last November, four out of seven supplements contained less ginkgo than claimed on their labels, and one failed to break apart properly to release its ingredients. Seven out of nine failed in tests in 2003, as did six out of 13 in 2005.
"It is now believed that ginkgo is among the most adulterated herbs," the company reports.
Tests by California scientists of two dozen ginseng supplements, reported in a nutrition journal in 2001, found that many differed from their labels. The concentrations of some ginseng compounds varied by up to 200-fold from product to product.
In tests, six out of nine chondroitin supplements failed testing in April 2007. One had only 8 percent of what it claimed to contain, and one "maximum strength" product had none.
Vitamins and minerals had problems, too. A "high potency" iron supplement contained less than half the amount claimed. Of 23 top-selling vitamin C pills, one provided less than half the amount promised; the suggested dosages of some others were beyond recommended safe levels. Of 10 vitamin A supplements, one provided twice its stated amount, raising concern about toxic side effects.
Last year, nearly 200 people were sickened by supplements containing up to 200 times the amount of selenium stated on the label. Symptoms included hair loss, discolored and painful fingernails, muscle cramps, joint pain, diarrhea and fatigue.
Ok they above sounds like a rip off: claiming to have something in it that just isn't there. But the problems don't stop there. What about putting crap into the supplement that isn't on the label and may be a banned substance or just some crap drug? This too has apparently happened:
Spiking Your Shake
"Random batch spiking" has a long history in the supplement business. It works like this: "The manufacturer sprinkles an illegal substance into an over-the-counter dietary supplement," says Feliciano. "The legal ingredients are claimed on the label, but they don't disclose the drug."

Chris Lockwood, formerly the senior category director of diet, energy, food, and beverage at the supplement retailer GNC and now a doctoral candidate in exercise physiology at the University of Oklahoma, recalls taking a popular protein powder in the early 1990s: "When I first took it, I got great gains. I felt great. I got strong. I got lean. But then something happened to it." Years later, he related his experiences to one of the product's formulators who confirmed for him that the powder had been spiked with Clenbuterol, an asthma drug that supercharges your metabolism.
So what is a consumer to do?
There are in the US alone about 4 various standards groups that certify supplements against the Good Manufacturing Process. These are Consumer Labs, mentioned above, the NSF, NPA and USP (we'll come back to these in a second). According to Wikipedia's entry on cGMP, this means,
Since sampling product will statistically only ensure that the samples themselves (and perhaps the areas adjacent to where the samples were taken) are suitable for use, and end-point testing relies on sampling, GMP takes the holistic approach of regulating the manufacturing and laboratory testing environment itself. An extremely important part of GMP is documentation of every aspect of the process, activities, and operations involved with drug and medical device manufacture. If the documentation showing how the product was made and tested (which enables traceability and, in the event of future problems, recall from the market) is not correct and in order, then the product does not meet the required specification and is considered contaminated (adulterated in the US). Additionally, GMP requires that all manufacturing and testing equipment has been qualified as suitable for use, and that all operational methodologies and procedures (such as manufacturing, cleaning, and analytical testing) utilized in the drug manufacturing process have been validated (according to predetermined specifications), to demonstrate that they can perform their purported function(s).
Process Check vs Spot Check. In other words how the stuff is made is checked, not just a given batch "randomly" selected to be tested by a lab. On some bulk supplement sites, they will post batch "certificates of purity" as a kind of quality control - and a person then has to take it on faith that that certificate matches up with the batch actually in the holder's control and that is then being parceled out from that batch (in another process, introducing another opportunity for contamination) into smaller tins.

In contrast, with GMP, the process of how a supplement is made is submitted to the certification body, assessed against the certification group's standards, and then audited in practice. The specific details of each group's auditing process are detailed on their sites, but here are the types of things they consider for certification:

USP (US Pharmacopia)
The USP Verified Mark helps assure consumers of a manufacturer's commitment to quality and helps them easily identify and choose a product that
  • contains the ingredients listed on the label, in the declared potency and amount
  • does not contain harmful levels of specified contaminants
  • will break down and release into the body in a specified amount of time
  • and has been made according to the FDA's Good Manufacturing Processes
A list of USP cert'd supplement companies can also be found on their web site.

"Will break down and release into the body" is a pretty important thing, isn't it? Seems obvious, but some supplements in those random tests have been shown to be inert - they don't break down at all even in acid, never mind water, like ever.

What does NSF certification of a dietary supplement mean to consumers?
NSF International was one of the first organizations to develop an independent product evaluation program to address the rapidly growing dietary supplements industry.
The purpose of our voluntary program is to test and certify dietary supplements products to
  • verify the identify and quantity of dietary ingredients listed on the product label;
  • ensure the product does not contain undeclared ingredients or unacceptable levels of contaminants; and
  • demonstrate conformance to currently recommended industry Good Manufacturing Practices (GMPs) for dietary supplements.
They seem to be missing that disolvability eh? But you can also check if your brand uses the NSF for their certification. Likewise if you're concerned about banned substances, NSF makes a business of certifying for this compliance, too.

Why so many certification labs? It's a business. NSF also tests tools. ConsumerLabs tests everything. USP and NPA don't. Why might a company choose one cert over another? Good question. Certifications cost money. One might also believe that the auditing practices of one group seem more amenable than another. It's worth digging into each program to see what you would find most comforting.

Natural Products? For instance, some of us like to privilege "natural" products in our supplements over synthetics. Whether there is a clear difference in terms of absorption or not can be debated, and indeed the vitamin D2 vs D3 debate is a great example of such a discussion (though vitamn D2 is from natural products that are vegetarian sourced and then irradiated rather than from squished fish and animal parts, but i digress).

For that preference, there is a GMP certification group focusing on standards for naturals. Called, naturally enough, the Natural Products Association. Their guidelines for GMP spec are quite detailed, too. They have a considerable list of companies on their listings as well, and it's great that these can be checked.

In the EU, the standards seem to be incredibly weak. Ya have to demonstrate that in quantity and quality, they are safe. Placebo is safe: having nothing in the supplement including what's on the label, is safe. Despite this breadth, the UK fought them: why pay money to say what you've been selling for years is safe, went the argument - at least in part. Gosh, sport, i dunno. Maybe it's NOT. That said, some folks think the legislation is protecting law makers rather than conusmers. But then what IS a consumer to do who wants to make sure what's on the label is what's in the tin?

In the UK, some companies do send their products to be tested. But that's product testing, not product process auditing. When they want to prove their goodness in terms of GMP, they can go the ISO (international standards) route and get ISO 9001:2008 accreditation.
ISO 9001:2008 specifies requirements for a quality management system where an organization
  • needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, and
  • aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.
All requirements of ISO 9001:2008 are generic and are intended to be applicable to all organizations, regardless of type, size and product provided.
So far,, claims to be the sole UK supplement maker with the 9001:2000 certification, never mind the ultra recent 2008 version (it takes the better part of a year or more to get to that certified process so no wonder myprotein has just been able to announce the slightly earlier standard).

Becuase i say so? Another company that makes natural products in the UK and claims to use Good Manufacturing Practice, for made-in-uk supplements, however, doesn't say how that claim is verified.
Another supplement shop suggests that GMP in the UK is self-regulated: it's GMP compliant if we say it is:

What is GMP?
Good Manufacturing Practice (GMP) offers quality assurance; it is a set of strict pharmaceutical regulations, codes, and guidelines that ensure that food supplements are constantly manufactured and controlled to a high standard which is suitable for use. Within the UK it is only legally applicable to medicines and veterinary medicines, however, GMP is a self-regulatory code within the supplements industry which is used alongside the regulations that are set out within the Food Supplements Directive.

Simply Supplements’ purchasing team ensure that all of our supplements comply with the Food Supplements Directive and that countless products are GMP certified.
I have not been able to find anything to show either that there is anything other than a shop claiming that their supplements follow GMP protocols in order to claim GMP "certified." That said, it seems like the only real EU-wide objective approach is the ISO 9001:2000/2008 certification. As in the states, there are a variety of groups set up to help organizations meet these criteria and get their practices assessed by accredited labs.

June 2010: Law comes back to the Supplement Wild West - sort of. Back in the states, apparently by June 2010, supplement companies will have to be compliant with minimum GMP to sell their wares (pdf of whole rule here). Hoorah. Sounds wonderful, doesn't it. Here's the irony. Remember, this law/ruling is for Dietary Supplement makers. So watch this exception:
The most important and obvious change is that the final rule does not apply to dietary ingredient suppliers and manufacturers. The burden of compliance with cGMPs fully lies with the dietary supplement’s manufacturer and requires dietary supplement manufacturers to test 100% of the incoming dietary ingredients.
Excuse me? So this sort of means that while manufactures have to be able to say what their processes are and list that their processes follow GMP, and that will take some cost and effort, who's to say what's on paper is what they do? Who is going to police this? The FDA itself is woefully understaffed. And while it can carry out random inspections, is the cost of a fine cheaper than the cost of changing manufacturing practice?

GMP - better than a kick in the head. There's something to be said, perhaps, for companies who have taken it upon themselves to pick up the cost of quality assurance third-party certification. There can be corruption everywhere, to be sure. Inspectors paid off, etc etc, but for the most part, why bother with the certification then? There seem to be a thriving fleet of businesses making money on supplements without any breath of certification.

So, take away: the above may help explain why some products cost a *little* more than others. Certification is not the big cost, but production mechanisms, practices and oversight for compliance DO cost more.

If the result of that process is both a safe-from-contaminent and quality product such that what's on the tin is *in* the tin, then that is value for money.

If you're not sure if your favorite supplement shop is GMP certified by a third-party, why not ask them? If enough people do ask, they might up their game. They may say no, they can't afford to raise prices. Likewise, you may decide it's too great a risk of potentially wasting your money *not* to get your sups from a GMP certified source.

ps - supplements that are likely *worth* investing in, based on the best of what we know?

  • fish oil or equivalent broad spec fatty acids
  • vitamin d
  • coq10
for performance ergogenics, additionally
  • protein/bcaa
  • creatine
if not confident of the vitamin quality of one's food:
  • a multi
  • some e
  • some magnesium
If into strength stuff

whey protein, creatine, b complex - the research on these guys is so long standing now and so repeated in terms of results, it's hard to argue. THough i would say pea protein and rice protein are also great alternatives - as algae oil seems to be for fish oil.

So for the few things that have been shown to add real benefit, may be worth chasing down the ones with the highest certified potency/quality/purity?

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