Despite its costs and deficiencies–and they are large and many–being cGMP compliant for supplement manufacturers, retailers, and testing laboratories is important.
It seems that almost every single day now, the news is filled with stories about how manufacturers are lying to consumers about their products–the same products we buy and trust to safely feed or supplement our family and children. One industry standard that helps keep manufacturers honest is cGMP, which stands for current Good Manufacturing Practice. In this newsletter, you’re going to read about a shocking, mind-blowing example connected to the Natural News Forensic Food Lab as to why it matters more than you can imagine. And despite its name, cGMP is not just about manufacturing. When it comes to supplements, cGMP applies to everything in the process–up and down the line. It is a set of guidelines that provides a system of processes, procedures, and documentation to ensure that the finished product has the identity, strength, composition, quality, and purity that it claims. And, it is important for you to understand cGMP so you can know whether or not you can trust the supplements you buy.
Manufacturers, of course, are bound by it. Surprisingly, companies that just store and/or distribute supplements are also legally required to comply with GMP regulations–with the exception of brick and mortar retailers. But online retailers such as Baseline Nutritionals are bound by it. Companies that specialize in supplying raw ingredients for supplements likewise have to follow a version of GMP, as do the testing labs that verify the purity and content of the supplements you consume. It’s the law, we’re all required to follow cGMP. But that doesn’t mean that everyone does. While most (but not all) manufacturers do and most testing labs do, it turns out that many ingredient suppliers do not (although they are required to follow Food GMP requirements), and very few retailers do. Why not?
Primarily because running a GMP compliant supplement operation is very expensive and time consuming. Following GMP really requires a full time Quality Assurance person. In fact, the FDA actually calculated the costs involved. The numbers they came up with are a bit shocking.
Small Companies (Less than 20 employees with annual revenue under $1M)
- Set up Costs = $26,000
- Annual Costs = $46,000
Medium Companies (20 – 500 employees with annual revenue of $5M – $10M)
- Set up Costs = $20,000
- Annual Costs = $184,000
When a company takes on that much cost to become compliant, it can’t just eat it. They have to pass it on to their customers, which means higher prices, which means you’ll be less competitive than those who aren’t GMP compliant. And that’s amplified up and down the chain. For example, in complying with GMP, Baseline Nutritionals is required to work only with GMP manufacturers, warehousing facilities, fulfillment houses, and testing laboratories–all of which cost more than their non-compliant counterparts, which means that each and every one of those additional costs gets added to the final retail cost.
Maintaining compliance is also a major pain in the butt. Many companies have gone out of business because they could not afford the extra time it takes or the extra cost to become compliant. Other companies have just ignored it and hope the FDA doesn’t come calling. Among other things, it requires regular onsite auditing of any company we work with to make sure they are GMP compliant. And when I say auditing, I’m not talking about simply visiting and saying hi. I’m talking about anywhere from a half day to a day-and-a-half, inch-by-inch walkthrough while working your way through a staggeringly detailed check list. To give you just one idea, when auditing a manufacturing operation, we need to make sure that no tree branches are growing too close to a facility as that could be an access point for squirrels and rats into the facility. And that’s just one of a number of items we have to check for even before we actually enter the facility. Trust me; it’s extensive, time consuming, costly, and it’s a pain.
So is it worth it?
What GMP Does NOT Cover
And the answer is a qualified, yes. But before we go into GMP in more detail and why it’s worth it, let’s cover some of the things that it doesn’t do.
- It doesn’t regulate effectiveness. Whether a formula works or not is not regulated by GMP. In fact, if no claims are made, effectiveness is not regulated by anyone. The bottom line is that it’s quite possible–in fact, quite common–to end up buying a cGMP compliant supplement that, for all practical purposes, does nothing and has zero benefits.
- It does not differentiate between synthetic and natural ingredients or organic and conventionally grown.
- It doesn’t control for potency of herbs. You can put either $5 a pound commercially grown ginseng in a formula or a $400 a pound wild crafted ginseng in the same formula. They both appear as ginseng on the label. Which do you think actually produces results? Which do you think most companies use?
- It doesn’t control where herbs are grown or where nutraceuticals are manufactured. Did that ingredient come the U.S. or from China? GMP doesn’t care.
- It doesn’t control the use of pixie dust. As long as no false promises are made on the label, nothing in GMP covers the use of minute amounts of an ingredient for the simple purpose of looking good on a label, even though it may have zero efficacy in the body at that level.
- It doesn’t regulate stupidity in formulation. For example, there’s nothing to stop a company from selling you a GMP compliant intestinal health formula that contains both goldenseal and probiotics because textbooks say that both are beneficial to intestinal health–even though goldenseal actually kills bacteria, including the probiotics in the same formula.
For these issues, you have to rely on the formulator and manufacturer to come through for you. Keep in mind that in the world of supplements, you often get what you pay for. If a supplement is selling at a bargain price, there’s usually a reason. Ingredients sourced from China usually cost a fraction of what those same ingredients cost if sourced in the U.S. Are ingredients from China automatically bad? Not at all. There are some very good, very conscientious companies in China, but there are also many that are not. At some point in time, when the government of the People’s Republic of China decides that the China “brand” is more important than exporting at any cost, things will change. Think Japan. In the 50’s and 60’s; they were known for cheap transistor radios and tiny cars. Now they are known for high end electronics, luxury cars, and top of the line nutraceuticals. Likewise Korea has gone from low end to high end. Most of the top rated appliances are now made in Korea. Make no mistake, China is already following in their footsteps–but for now, when it comes to herbs and nutraceuticals, buying from China is problematic. Unless you have boots on the ground and are regularly working directly with the Chinese companies and farmers involved in producing your raw ingredients for the casual supplement user, you don’t know what you’re getting. Again, it’s a shame to tarnish the good Chinese companies, but that lack of regulation in China is why Baseline Nutritionals avoids buying ingredients from China as much as possible. (Note: some ingredients such as many of the herbs used in traditional Chinese medicine are impossible to get anywhere else now. In those cases, we vet the sources as much as possible and make sure that everything is tested to the nth degree before we use it in any formulation.)
The bottom line is that GMP doesn’t cover any of this. The FDA doesn’t cover any of this. You have to trust the company you buy from to cover it for you. It’s like buying champagne. When you buy Andre at $5 a bottle, you know you’re not going to get Cristal, which retails for $374 a bottle. They’re not the same. The bottom line is that cGMP aside, when it comes to supplements, you need to find a company you trust; then buy as much as you can from them.
Which brings us to the questions at hand: if GMP doesn’t guarantee us any of this, what value is it? What does it cover?
What GMP Does Cover
According to the FDA’s own website, current Good Manufacturing Practices (CGMPs) require that proper controls be in place for dietary supplements so that they are processed in a consistent manner, and meet quality standards.1 “Dietary Supplement Current Good Manufacturing Practices (CGMPs) and Interim Final Rule (IFR) Facts.” June 22, 2007 FDA. Accessed 29 Mar 2014. http://www.fda.gov/Food/GuidanceRegulation/CGMP/ucm110858.htm#fr The CGMPs apply to all domestic and foreign companies that manufacture, package, label, or hold dietary supplements, including those involved with the activities of testing, quality control, packaging, and labeling (an important consideration as we will see later), and distributing them in the U.S (i.e. selling them). The requirements include provisions related to the design and construction of physical plants that facilitate:
- Proper manufacturing operations
- Quality control procedures
- Testing final product or incoming and in-process materials
- Handling and recording consumer complaints
- Maintaining records
Although the requirements are not as rigorous as found in the pharmaceutical industry, much of the wording and intent is the same. Specifically, anybody involved in manufacturing and distributing dietary supplements is required to keep detailed records documenting all standard operating procedures (SOPs) and they must have a formal process for reviewing and updating SOPs. In addition, training records for all employees must be kept current and a master manufacturing record for all formulas must be maintained. That said, there are differences. For example, drugs have to be FDA approved before marketing, whereas dietary supplements do not. Another important difference is that drug testing must be done for all active components in a pharmaceutical product, but there are exceptions available for dietary supplements. Also, equipment and analytical methods have to be fully validated for drug products, but only qualified for supplements.
Regardless, cGMP compliance requires extensive record keeping and requires access to these records by the FDA on demand. Identity testing must be performed on every dietary ingredient used in each and every batch of a formulation. This can be performed by the manufacturer or by the ingredient supplier, but the manufacturer is ultimately responsible for verifying the reliability of the supplier. Note: although ingredient suppliers are exempted from the regulation–putting the burden for compliance on the manufacturers–most manufacturers require their raw material suppliers to meet these regulations or they won’t do business with them. And as mentioned earlier, the raw dietary ingredient suppliers are still subject to Food GMP regulations.
cGMP Compliance for Retailers
GMP compliance for online retailers is different and only slightly less complex. In fact, it is largely designed to govern the interface between the manufacturing process and the retailing process. For example, GMP requires that companies like Baseline Nutritionals keep a Master Formula record for every product they create and sell. This record contains complete details as to exactly what the specifications are for every ingredient that goes into the formula, not to mention precise instructions as to exactly how the formula is to be packed and any scoops or droppers required.
That master record is kept on file at the manufacturer. When a purchase order is made, the manufacturer is required to verify that they have precisely matched it before completing the order and forwarding it to product fulfillment. But it doesn’t end there, GMP requires that before any of those formulas are released to the public, the sales group must also verify that the formula is in full compliance with the master formula record. In addition, label verification is required for every product, every batch, to make sure that what’s in the bottle matches what’s on the label–something, that as you will soon see, is not necessarily automatic.
In addition, we’re required to keep multiple samples of every batch of every formula in storage in case any retesting of those batches is required. It may not sound like much, but multiple samples, of multiple batches, of multiple products adds up over the years and requires a lot of storage space, which costs money.
And finally, as mentioned earlier, GMP requires that we regularly audit all manufacturing operations on a regular basis with live, onsite inspections. This not only increases cost for the online retailer that is in compliance and regularly audits all its manufacturing operations, but think what it means for the manufacturing operations. These added costs, of course, all end up getting passed on to customers. In other words, cGMP compliance costs money, and we’re not done yet.
GMP Compliance for Testing Labs
Natural News stated that they were the only company in the industry that tests every product. In fact, that is wildly and unconscionably untrue. If you’re GMP compliant, testing takes place at every level of the process and for multiple things such as the ingredients inside the canister conforming to the label…not just heavy metals. Many companies test for heavy metals. Baseline Nutritionals tests every batch of every product for heavy metals, again along with a number of other things as required by cGMP.
As already mentioned, before manufacturing a product, every ingredient is tested to make sure it’s what it’s supposed to be, not something merely similar, or something that merely looks like what you want. For example, if you’re putting Panax ginseng in a product, you have to run it through testing to make sure the ingredient supplier hasn’t sent you Siberian ginseng by mistake. They are very different plants (Siberian ginseng isn’t actually even ginseng; it’s Eleutherococcus), with very different bioactives. Siberian ginseng is also much cheaper, and ingredient suppliers sometimes do “accidentally” confuse the two. The bottom line is that if you want to verify that you’re getting what your formula calls for, you have to test each ingredient as it comes in. This is a GMP requirement. If you’re not GMP compliant, you don’t do it, and you save money. Then again, your final formula may not be what you think it is and may not match what’s on the label.
In addition, both bio-friendly ingredients and final products need to be tested for micros. That is, they need to be tested for bacterial contamination such as E. coli and salmonella. This is crucial, when you’re dealing with any ingredients that were once alive or grown–no matter how organic the source. And again, it’s a GMP requirement.
After a product has been manufactured, but before you sell it to the public, it’s a good idea to test it with an ISO accredited, GMP compliant, third party, independent laboratory for heavy metal contamination. (Incidentally, this is something that Baseline Nutritionals does as a matter of course with every batch of every product we sell. Yes, it costs more to send products out for testing to certified testing labs, but I insist that Baseline take its mission statement–When Compromise Is Not an Option–very seriously. I don’t make my formulations for the casual supplement user, but for those who insist on using the best. And we are not alone. There are other companies that are similarly obsessive.) And when it comes to testing laboratories, there are several levels of qualification for determining which lab to use. In descending order, they are:
- ISO/IEC 17025:2005 accredited2 http://www.a2la.org/requirements/req17025.pdf (International Organization for Standardization). Accreditation is actually done on a test by test basis. In other words, a lab can be accredited to run tests on only a handful of heavy metals, or on the whole gamut. Testing for protein, for example, requires a separate accreditation.
- cGMP compliant3 http://www.ecfr.gov/cgi-bin/text-idx?SID=f3daa4e9ddbdf07acd8dae88535d39f1&node=21:220.127.116.11.11.10&rgn=div6
- GLP (Good Laboratory Practices) compliant
- Having some equipment and doing your own thing
At Baseline Nutritionals, we run every batch of every product through testing with labs that are ISO compliant or accredited for the particular nutrient or contaminant that we’re looking for. That’s the best you can do. Obviously, the least desirable is using labs that are not compliant and have no accreditation. If a lab does not yet have their ISO/IEC 17025:2005 Accreditation then we send out a qualification questionnaire. Click here to see the screening questions used to sort through testing laboratories to make sure that they are both qualified and up to the task at hand.
Bottom Line: Does GMP Matter?
So, we now know that GMP makes products more expensive, is a pain in the butt to implement and enforce, and has huge gaps that negate much of its value. But we’re still left with the bottom line question: Does it matter? Is it worth it?
I’m going to give you a real life example–then let you make up your own mind. But before we turn to the example, let’s take note of what Andrew C. von Eschenbach, the Commissioner of Food and Drugs, said about the new GMP rules for dietary supplements in June of 2007:4 http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/DietarySupplements/default.htm “This rule helps to ensure the quality of dietary supplements so that consumers can be confident that the products they purchase contain what is on the label.” And now the example.
Last year, Natural News purchased some testing equipment which they used to establish the Natural News Forensic Food Lab. And since that time, they have been analyzing a number of companies’ products for purity and contamination. In effect, they set themselves up as the voice of higher moral authority in the alternative health community and pretty much stated so in those words. Along the way, they have taken a position that vegan rice protein contains too many heavy metals and that the organic whey they offer through the Natural News marketplace is a cleaner, better alternative…using test results from their own Forensic Food Lab, which as far as we can determine is non-compliant and non-accredited, to back up their claims.
Note: before I go any further, let me clearly state that I like Mike Adams, the Founder and Director of Natural News. I’ve known him for years and consider him a friend. I also think that Natural News does some great work, even if they seem to have a lot more belief in conspiracy theories than I think appropriate. What follows, then, is not personal. It’s just that I think it’s crucial that if you set yourself up as judge, jury, and executioner in an industry–as the Judge Dredd of alternative health, if you will–you have to walk the talk. You must be beyond reproach if you choose to pass judgment on other companies and their products. Or as the Bible says, “Judge not lest ye be judged.” (Matthew 7:1)
Now back to our example in which Natural News chose to question the purity of rice protein products and promoted the purity of their whey product instead.
A few days ago, the Baseline of Health Foundation was sent copies of lab reports on the Natural News whey protein powder that had been run by two independent, third party ISO accredited laboratories (Genysis Nutritional Labs5 http://gnlabs.net/ and Covance6 http://www.covance.com/
), using the Kjeldahl testing method for protein. We were stunned by what we saw.
The whey product was definitely heavy metal clean as Mike stated, but that wasn’t the shocking result. That result concerned the protein levels in the formula. Unfortunately, although both labs are huge and notably accredited (Covance alone has over 12,000 employees and has been involved in the development of one-third of all prescription medicines in the market today), neither was specifically ISO/IEC 17025:2005 accredited for protein testing. Nevertheless, we were so stunned by what we saw that we obtained a sample of the whey protein for ourselves (same lot number) and sent it off to two actual ISO/IEC 17025:2005 protein testing accredited laboratories (Medallion Labs7 http://medallionlabs.com/) and Warren Analytical Laboratory 8http://warrenlab.com/, using an alternative testing method (Dumas9 Thompson M1, Owen L, Wilkinson K, Wood R, Damant A. “A comparison of the Kjeldahl and Dumas methods for the determination of protein in foods, using data from a proficiency testing scheme.” Analyst. 2002 Dec;127(12):1666-8. http://www.ncbi.nlm.nih.gov/pubmed/12537377 ), which normally tests slightly higher than Kjeldahl, to verify the results.
What were those results?
The two labs using the Kjeldahl test found only 5 g of protein per serving. The Dumas test from Medallion showed slightly more at 5.03 g per serving (20.1% x 25 g), whereas the test from Warren found slightly less at 4.75 g. Bottom line: all results were a long way from the 21 g10http://store.naturalnews.com/assets/images/Vanillalabela.jpg on the label. (Check out the results for yourself.) We’re talking about a difference of 400% between what the label says and what’s actually in the canister, and it’s insanely low for a product promoting itself as a protein supplement. In fact, I’ve never heard of a whey protein product having so little protein before. For perspective, it’s less protein than a glass of milk, which comes in at around 8 g. Milk, then, has 60% more protein than the whey Natural News endorses. Somehow in the process of “concentrating” the protein while making the whey, it actually lost 40% of the protein that was already there. Keep in mind that a cup of Greek Yogurt contains about 300% more protein. And a scoop of most rice protein products contain about 25 g, which would be about 500% more protein per serving.
What does this mean?
It means that:
- Neither the manufacturer of the whey, Natural News which sells it, or the Natural News Forensic Food Lab are cGMP compliant. No matter what may be claimed, they couldn’t be, or this would have been noticed at every step of the process. Label validation is part of the process.
- It also means that just because you buy a piece of testing equipment and give it a name (Natural News Forensic Food Lab, in this case) doesn’t mean that your lab is GMP compliant. And this means that your results can be off by, as we now know, as much as 400%.
- And finally, it means that the Natural News whey, has an even bigger anomaly. The label currently lists protein at 21 g, fat at .4 g, and carbohydrates, as 1.98 g. But given that the protein content actually tests out at only 5 g per serving, we now have over 16 g of unaccounted for “what”?????
Incidentally, it also means that the Natural News whey isn’t quite as clean as they claimed even if their non GMP testing on heavy metals was accurate. To compare equivalent amounts of protein, you would have to multiply their testing results fivefold. And keeping in mind that the Natural News report stated that even though the level of heavy metals in rice protein products might be safe at one scoop, many people such as athletes have up to six scoops a day,11 http://www.naturalnews.com/043978_heavy_metals_dietary_supplements_food_science.html and that would present a problem. Well, what we’ve now learned is that with the Natural News whey you’d have to consume 30 scoops a day, which presents its own set of problems, assuming you could actually eat that many scoops in a day.
In his Feb 8th newsletter on Vegan Protein,12 Mike Adams. “Vegan protein heavy metals results republished by Natural News in new, improved charts.” February 08, 2014. Natural News (Accessed 8 April 2014.) http://www.naturalnews.com/043838_rice_protein_heavy_metals_data_charts.html Mike Adams says, “Once again, we are pioneering the new course for the future of the natural products industry, setting new standards for product safety and total transparency with customers…My philosophy is that I won’t sell anything that I wouldn’t be absolutely thrilled to eat for myself. If I don’t feel right about a product, we don’t carry it, period. I just wish everybody in the industry had the same ethics.”
Inherent in that quote is the problem we confront today. Before you set up new standards that you intend to impose on everybody else, you at least, for your own products, have to follow the standards that are already in place. And if you’re going to set up a “lab” to pass judgment on individual products, companies, and even entire segments of the industry, then that lab better be GMP compliant and ISO/IEC 17025:2005 accredited for each and every test it runs. Otherwise, you’re liable to end up with “whey” on your face and your credibility as the ultimate “ethical” authority of the natural foods industry turned upside down. Or to put it another way: I’m not sure that selling 5 g of protein per scoop for $48.50 a canister qualifies as the “new course for the future of the natural products industry.”
I debated for several days on what to do with this information. Unlike Natural News, I’m not really into attacking companies within the alternative health industry–the FDA and big pharma do enough of that without help from one of our own. Then again, I have no problem countering erroneous information when I see it and defending others against inappropriate attacks when they occur. In the end, I simply couldn’t ignore the test results, especially since I knew that other people who weren’t so kindly disposed towards Mike and Natural News were also aware of these results, The bottom line, though, is that it is the mission of the Baseline of Health Foundation to inform, and no matter how kindly disposed I am towards Natural News, this is a story that consumers have a right–and a need–to know about. I believe that Mike Adams and Natural News do more good than harm, and I personally like them. But proclaiming yourself the natural nutrition industry’s, “higher testing authority” and missing the mark when it comes to testing your own products by 400% is simply unacceptable.
The bottom line is that you might want to take any numbers from any company that uses non-GMP compliant manufacturers, is not compliant itself, and that does all its testing in house in a non-compliant, non-accredited facility with a grain of salt.
And in addition to Matthew 7:1 that we cited earlier, Natural News might want to contemplate John 8:7, “Let he who is without sin cast the first stone.”
What it comes down to is that there’s more to quality assurance than just good intentions. As we’ve seen today, good intentions by themselves may only get you within 400% of reality–give or take. And when that 400% error is in the one measurement that’s actually the very raison d’être for your product (the amount of protein in a protein powder), it’s kind of a big deal in terms of the credibility of any of your test results. I think all of us in the industry are hoping that Mike Adams and Natural News stop using pseudoscience as a marketing tool to denigrate competing products and companies and that they stop trying to act as a higher moral authority. There are many moral and ethical companies outside of Natural News. As an industry, we need Natural News to step back from the brink and return to the hardcore reporting on which they built their well-deserved reputation.
In conclusion, you can judge for yourself, but I believe that despite its costs and deficiencies–and they are large and many–being cGMP compliant is important. If you’re ever in a position where “compromise is not an option” when it comes to the supplements you take, would you want anything less–could you afford to settle for anything less?
On April 16th, Natural News announced that they were taking our advice and had begun initiating the process to achieve ISO 17025 accreditation for their Natural News Forensic Food Lab.13http://www.naturalnews.com/044744_rice_protein_heavy_metals_petition_organic_superfoods.html This is good news, and they should be applauded for moving in that direction. It may turn out to be a more difficult process than they imagine, however. The standards are quite rigorous–but that’s why the results from accredited labs can be relied upon. Nevertheless, once they achieve that accreditation, test results coming out of the Forensic Food Lab can be viewed as authoritative. Until then, however, they should be viewed with a high degree of skepticism.
Then, on April 18th, Natural News acknowledged that the facts as stated above were correct and that the One World Whey that they had been endorsing, personally guaranteeing, and selling indeed contained only 5 g of protein per scoop as stated above.14 http://www.naturalnews.com/043617_one_world_whey_clean_protein_heavy_metals_lab_tests.html They also announced that sales of the current production of One World Whey had been halted. Of course, we now wait to see the announcement that the Natural News Marketplace has become cGMP compliant, as this would have rendered the entire article unnecessary and, in fact, the entire situation impossible.
References [ + ]
|1.||↑||“Dietary Supplement Current Good Manufacturing Practices (CGMPs) and Interim Final Rule (IFR) Facts.” June 22, 2007 FDA. Accessed 29 Mar 2014. http://www.fda.gov/Food/GuidanceRegulation/CGMP/ucm110858.htm#fr|
|9.||↑||Thompson M1, Owen L, Wilkinson K, Wood R, Damant A. “A comparison of the Kjeldahl and Dumas methods for the determination of protein in foods, using data from a proficiency testing scheme.” Analyst. 2002 Dec;127(12):1666-8. http://www.ncbi.nlm.nih.gov/pubmed/12537377|
|12.||↑||Mike Adams. “Vegan protein heavy metals results republished by Natural News in new, improved charts.” February 08, 2014. Natural News (Accessed 8 April 2014.) http://www.naturalnews.com/043838_rice_protein_heavy_metals_data_charts.html|