Your buddy is taking a new workout supplement that he just raves about. Or there was a mega-sale on vitamins/herbs at your grocery store. Maybe you saw an ad about a “natural” product that brings back your sexual energy like you were 18 again. I mean, the ad had some sexy women in it so it must work, right? Who hasn’t been hypnotized by clever marketing and visions of the perfect “after”? But before you work more OT to buy that 30-day supply you’re going to want to read this.
There are over 85,000 supplements on the market today. Between 2004-2013, there were over 23,000 Emergency Room visits because of dietary supplements alone (*and this data was taken from only 63 Emergency Departments). The top three reasons for adults were supplements taken for weight loss, performance enhancement and sexual dysfunction.
Supplements are regulated as food, not drugs, under the FDA.
Unlike drug companies that have to prove the safety of a product before it’s sold, supplement companies don’t need any pre-market documentation before they sell (unless it’s a new dietary ingredient). They basically agree to follow Good Manufacturing Practices (cGMP) which regulates the processing plant, the cleanliness, quality control, record keeping, consumer complaints and (the biggie) that the product meets label claims. So with a handshake promising to abide by cGMP, they are in business. No pre-check of those supplements they are going to sell to you and your family.
The FDA does random audits on supplement companies. And consumers can report any adverse effects they had directly to their website. But according to the FDA website: “In that FDA has limited resources to analyze the composition of food products, including dietary supplements, it focuses these resources first on public health emergencies and products that may have caused injury or illness. Enforcement priorities then go to products thought to be unsafe or fraudulent or in violation of the law.”
The FDA also bears the burden of proof that a supplement is unsafe or adultered. So, if there are a lot of self-reported adverse effects on their website, the product may be pulled but then the FDA has to prove it’s bad stuff. So unless your supplement has been audited by the FDA (and it could be awhile before this happens), it remains on the market.
How well is this system working?
According to Natural Product Insiders (industry regulator), between 2010 and 2012 the FDA performed 626 inspections. Of these, 444 resulted in non-compliance violations. That’s almost 70% of supplement companies. The biggest compliance issues were failure to test appropriately, failure to keep adequate records and presence of things you just don’t want like pharmaceutical drugs, dietary ingredients not listed and contaminants.
Some compliance issues you may want to know about:
- Product identity – It may not contain the ingredient you purchased. Plus, it may contain an ingredient you didn’t want at all.
- Quantity of ingredients – It may have have your ingredient but in higher or lower amounts (may lead to nutrient toxicity).
- Ingredient safety – does it have toxins in it?
- Adulteration – there may be a banned ingredient or pharmaceutical drug in it.
Why is this bad? Besides the obvious, if your supplement has something in it that is NOT listed on the label, it may interact with another drug or supplement you’re taking. Which could be seriously harmful.
Here is a free drug-interaction check site to assist you.
Made in the USA (?)
Another concern is buying raw materials from overseas. Although imported materials may be “certified” for quality, this doesn’t really mean much in the USA. One example was an overseas supplier that used a diesel generator to dry their herbs. The result was unwanted lead in the finished product. The FDA does random audits on imports too, but can’t check them all. In a world where most everything is imported, be concerned. And it’s very easy for anyone to slap a “Made in the USA” label on their product. Unless the product is audited, you’ll never know where they got their raw materials from.
Would you eat a “shit sandwich”?
I’m guessing NO. But poop is natural. But “natural” doesn’t mean safe. Even natural herbs that have been used safely for thousands of years can be deadly if taken in high amounts. Does anyone remember E’ola drops? They were made with Ephedra, a stimulant. People were throwing back E’ola like it was tequila which resulted in serious health issues and deaths. Ephedra was finally banned for sale in the USA in 2004.
Which companies can you trust?
Some companies do “skip batch testing”, which means only certain batches of supplements are tested for quality, but not all of them. It’s a start but has it’s risks. An example being a preemie infant who was given children probiotics in the hospital. The probiotic was from a (decent) company that only did batch testing. Unfortunately the batch used was not tested and contaminated with mold. This caused a serious infection which led to the infant’s death.
So look for companies that test every single batch in-house. Emerson Ecologics in an online store that has a rigorous assessment process to ensure that the products on their site meet and exceed the FDA cGMP practices. It’s a good place to search for brands.
Just to be clear, the FDA does not have a stamp or seal that says “GMP verified/certified”. In fact, they don’t even have a list of companies that have passed GMP inspections. But they do have a list of ones that were issued warning letters.
There are 3rd party, independent companies that perform their own GMP verification on supplements. Some of these companies are USP (US Pharmacopeia), Consumer Lab, NSF (NSF International) or Natural Products Association.
Remember, these independent seals only verify the contents, not the safety or claims.
NSF for Sport has a free site to check if your sport supplement has passed their quality check.
The US Military created a kick-ass, 100% free site where you can check for supplement safety. Created because our servicemen were getting ill or dying from off-brand, questionable supplements. If you’re a gym-rat, this is your rabbit hole.
If you’re out shopping, here a list of high-quality retail brands to look for:
Nordic Naturals (fatty acids)
Barleans(Fatty Acids)
Nature’s Way
Enzymatic Therapy
Jarrow
Megafood
New Chapter
Pioneer
Gaia herbs
Herb Pharm
Now
Carlson’s
Garden of Life
Renew Life
And lastly, if you purchase from your practitioner, it’s most likely from a professional line with extremely high quality standards.
Free credible sites to do your research
http://www.nsfsport.com (see if your workout supplement is legit)
http://www.npainfo.org/NPA/EducationCertification/GMP_Certification/GMPCertifiedCompanies.aspx (companies that passed 3rd party certification)
http://www.quality-supplements.org/verified-products/verified-products-listings (companies that passed 3rd party certification)
https://www.fda.gov/ICECI/enforcementactions/warningletters/default.htm
References
https://www.health.harvard.edu/staying-healthy/ephedra-ban
https://nccih.nih.gov/health/ephedra
https://www.fda.gov/Food/DietarySupplements/default.htm
https://www.fda.gov/food/guidanceregulation/cgmp/
https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm153239.htm
https://www.accessdata.fda.gov/scripts/importrefusals/
https://emergency.cdc.gov/han/han00373.asp
https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm466588.htm#1
Geller AI, Shehab N, Weidle NJ, et al. Emergency Department Visits for Adverse Events Related to Dietary Supplements. N Engl J Med. 2015;373(16):1531-40.
