Supplement quality is a constant challenge here in the United States, for many reasons. One of the main challenges is that the FDA, the government agency responsible for ensuring safety and efficacy of supplements, is heavily employed by individuals with significant ties to commercial supplement interests. Another challenge is that funding for the FDA is limited enough that reliable, consistent enforcement of existing laws is laughable, at best. There is simply not enough manpower to enforce current laws on the books, so it takes significant consumer harm and backlash to get investigations underway.
Despite this, the New York Attorney General conducted an investigation in 2014 and 2015 on common supplements one can purchase over the counter. The degree of label misrepresentation was astonishing and, quite frankly, morally reprehensible.
In the graphic above, you can see that most of the supplements tested had no traces of DNA matching the labeled material being tested. There is some argument that the method used (DNA barcoding) may be inaccurate as an extracted, dissolved, crushed or otherwise altered plant may have altered DNA that was not detected as it was compared to whole plant DNA. Even if this were so and it accounted for the Attorney General’s findings, it does not excuse the fact that GMP standards (the standard by which supplement companies are supposed to adhere to) were not met in over 50% of the 450 companies inspected by the FDA. Note that the FDA does not even have enough resources to inspect all operating facilities in the USA.
The GMP stands for ‘Good Manufacturing Practices’. This is the absolute basic level of quality a manufacturer is expected to adhere to – maintaining sanitary facilities, preventing cross contamination, documenting of procedures, the ability to trace batches and systems to recall products if necessary, etc. The GMP has no enforcement of quality of the product or the raw materials in the product. Over 50% of tested facilities had violations ranging from no written formula available for their product and no concerns for cross contamination of major allergens to products contaminated with rat feces. So yes, you supplement may literally be full of shit.
Basically in the GMP we have a set standard that is unenforceable and so it can’t even assure us that what is on the label is in the label. Investigations consistently show that there are major problems with the supplements most Americans have access to. Consumer Labs reports 1 in 4 products has a major problem – from significant deviation of the amount in the product vs what is listed on the bottle, to rancid oils and products that won’t break down in the body – the ‘expensive urine’ you’ve been warned about.
What on earth do you do?!?!
Well, according to the graphic above, it would seem best not to get generic supplements available from big box stores.
Beyond the FDA are some consumer watchdog groups that are our best bet for quality assurance – many of these were created before the GMP standards came into play, but remain a higher quality than what the FDA can assure us right now:
ConsumerLabs.com is a for profit company. A supplement company can pay them to have their product tested for quality and carry the Consumer Lab seal of approval. If that product fails to meet criteria it will not be listed on the website. However, if Consumer Lab purchases the supplement from a store and the supplement fails they will post results on their website. So it’s a ‘give us money and you can choose to post results or not’ situation, unless they purchase the product from a store, much like you would, and test it themselves.
A Consumer Labs seal of approval will assure that:
- contains the key ingredients listed on the label in the declared potency and amounts; it does not contain harmful levels of specified contaminants using stringent limits, for example, California Proposition 65.
- Product disintegrates or dissolves per USP standards (75% or more dissolves in less than 60 minutes time)
- The product contains the tested ingredients listed on the label in the declared amounts and of high quality; any health claims must comply with FDA regulations.
USP – United States Pharmacopeia. This third party non-profit tests ingredients, finished products and conducts facility audits. Learn more about the USP here.
A USP certification assures that:
- The product contains the ingredients listed on the label in the declared potency and amounts; it does not contain harmful levels of specified contaminants; and it has been manufactured according to FDA current GMPs and USP GMPs.
- Absence of ingredients with known safety risk; appropriate allergen labeling; meets acceptable levels of specified contaminants, based on toxicologic concerns; testing per California Proposition 65 for labeling purposes.
- Product disintegrates or dissolves per USP standards.
- Product label has an accurate list of ingredients in the stated amounts. All claims of fact, either stated or implied, must be supported by data, consistent with USP program requirements. Any health claims must be within FDA regulations.
- Label claim review to certify that what’s on the label is in the bottle
- Contaminant review to ensure the product contains no undeclared ingredients or unacceptable levels of contaminants, including >200 athletic banned substances for Certified for Sport products; it has been manufactured according to FDA’s current GMPs.
- All claims of fact made for the product, either stated or implied, must be accurate, consistent with NSF program requirements, and meaningful in terms of the benefits offered.
Therapeutic Goods Administration of Australia – considered the most stringent and vigorous of certifying bodies, the TGA requires the same amount of testing for supplements as done for pharmaceutical drugs, as Australia does not distinguish between supplements or drugs. Down under, your multivitamin is considered ‘complimentary medicine’. Very few companies in the USA are certified through TGA. This is considered the gold standard worldwide.
Make sure that the company you use has the final product being tested to ensure that what is on the label is in the label, that contaminants are absent. You can contact them directly and ask them what they are doing for quality assurance and ask for proof if you do not see it on their website or you can check out Consumer Labs.
Thorne Research is a company that has transparent, clear quality assurance that they openly share with their customers. Many companies will not have their quality assurance clearly listed on the website, nor will they even have a number to call to get information! Pharmaceutical grade supplements that are available from practitioners will often meet these higher standards, share them openly, and remain consistent in testing to assure quality. This is precisely why licensed professionals use them; a quality standard is essential to producing reliable results for patients. You can read Thorne’s Quality Assurance here. (Note – I do not financially benefit from recommending Thorne. I simply like them, trust them, and use them myself, along with other pharmaceutical grade companies.)
Knight, Peter, ND. (2016). Whole Foods Nutrition and Supplementation: Week 10: Lecture 2: Quality Issues in the Dietary Supplement Industry [class notes].
O’Connor, Anahad. New York Attorney General Targets Supplements at Major Retailers. New York Times, FEBRUARY 3, 2015. Accessed online 27 September 2016
THE EDITORIAL BOARD. Conflicts of Interest at the F.D.A. New York Times, APRIL 13, 2015. Accessed online 27 September 2016.
Unknown. (2016). Quality Certification Programs for Dietary Supplements. JOURNAL OF THE ACADEMY OF NUTRITION AND DIETETICS. Volume 116 Number 9