What I wish everyone knew about supplements

 

(this article was originally written by me for Police One but bears repeating)

I wanted to turn away, but I couldn’t stop looking. Right before me on the TV at Best Buy was a commercial for a “natural weight loss” supplement.  The unrealistically flawless actors laughed as they popped a pill and played grab-ass. The parting shot was a herd of toned legs and butts running down the beach.  Photos of colorful fruits and vegetables appeared to promote the naturalness of this product.  I kept shaking my head as it slipped into the “buy it now or you’ll die” phase.  Next to me, also glued to the TV, was a modest, fleshy woman in her 40’s.  She had a wide grin as her eyes held the screen.  I wanted to say “do you believe this crap?” but it was pretty clear she did.  She grabbed her phone and began to search for (what I assumed) the website.

As healthy skeptic, I looked it up too. For $49.99 plus shipping, she was on her way to a 30-day supply of….a big disappointment. It contained basic ingredients you could get during breakfast: caffeine, B-Vitamins, green tea extract. But in proprietary amounts. Kale and Alfalfa was also somehow stuffed inside. The most risky thing was that this was a new product with some ingredients “sustainably sourced from their natural region overseas”.   

You may be thinking “so obvious” but there’s more reasons to raise a brow.  Reasons that impact your supplements too. 

Supplements are regulated under food, not drugs.

In 1994, the Dietary Supplement Health and Education Act of 1994 (DSHEA) was created. It regulates supplements under a specific food category, not as a drug.  What this means is that, unlike the drug manufacturer that has to prove his drug is safe prior to hitting the market, a supplement can be sold without any premarket documentation. The only caveat being if there is a ‘New Dietary Ingredient’ (NDI), an ingredient that hasn’t been marketed in the USA prior to 1994. 

The FDA has on their website in bold the following statement: “FDA is not authorized to review dietary supplement products for safety and effectiveness before they are marketed.” 

Now the manufacturer does have to be in compliance with ‘Good Manufacturing Practices’ (cGMP) regulations.  This covers stuff like quality control, record keeping and testing of the incoming, in-process and final products.  But the FDA bears the burden of proof that a company is in non-compliance with the cGMP’s through audits.

You may believe that every single supplement is tested to confirm that the label matches what’s inside and nothing else. This isn’t always the case. 

From the FDA:

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.

I almost forgot. Add this to their to-do list: regulating and monitoring imports. Talk about overload. Need a scary bed-time story? Check out the FDA ‘Import Refusal Report’.  This represents a small slice of what crosses our borders (and is actually caught by the FDA).

Bottom line: Lots of supplements. Not enough workers to get to them all.
 

How well is this system working?

There are over 85,000 supplements on the market today.  Americans spend $30 billion dollar a year on them. 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 because of supplements taken for weight loss, performance enhancement and sexual dysfunction. 

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 things you just don’t want in your supplement like pharmaceutical drugs, dietary ingredients not listed and contaminants.  

Read more about it here: https://www.naturalproductsinsider.com/news/2013/05/fda-gmp-inspectors-cite-70-of-dietary-supplement.aspx

Some of the compliance issues you want to know about: 

  • Product identity - My not have the ingredient you purchased in it. Or it may contain an ingredient you didn’t want at all.
  • Quantity of ingredients - It has your ingredient but in higher or lower amounts.
  • Ingredient safety - does it have toxins in it?
  • Adulteration - there may be a banned ingredient or pharmaceutical drug in it.

Why you need to know what’s inside.

I know you don’t want heavy metals, poop or pharmaceutical drugs in your supplement (product identity/adulteration).  But what about more (or less) of an ingredient you paid for? Before you think “more is better!”, know this: some vitamins are toxic in high amounts.  And some herbs have dangerous interactions with medications.  

Want examples? St. John’s Wort can speed up the metabolism of prescription drugs like anti-depressants and birth control (uh oh).  Too much Vitamin A can cause headaches, fatigue or nausea.  Take a blood thinner? Vitamin K can interfere because it helps with blood clotting.  Having surgery? Avoid Omega-3, turmeric, garlic and Vitamins E & C (to name a few).

Free drug-interaction checker here


So how do I find a quality product?

There are a few ways to find a quality product:

  • cGMP 
  • Independent/3rd party certification 
  • Reputable companies that test every batch.

Shopping for supplements on the internet is like buying a taco from an unknown street vendor. You never know what you’re going to get. And it may not end well. Listen to your gut and stick with legit products. 

cGMP and 3rd Party Verification

Although the FDA does not have an official seal or stamp or a list of companies that passed inspection, they do have a searchable ‘warning letter’ database: 

https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm

Natural Products Insider in an independent company that offers a third-party NPA-GMP certification to companies that meet a high level of compliance to the NPA-GMP Standard as verified through comprehensive third-party inspections of facilities and GMP-related documentation.  They have an updated list here:

http://www.npainfo.org/NPA/EducationCertification/GMP_Certification/GMPCertifiedCompanies.aspx

NSF is another independent company with third-party certification that lists companies in compliance with cGMP’s: http://info.nsf.org/Certified/GMP/Listings.asp

NSF for Sport has a searchable list for sport supplements that are third-party cGMP certified (they have a free app too):  http://www.nsfsport.com

USP Dietary Supplement Verification Program offers third-party GMP testing with a searchable UPS verified database: http://www.quality-supplements.org/verified-products/verified-products-listings or 

http://www.usp.org/verification-services


Reputable companies

Some companies do “skip batch testing”. They test random batches for quality control and verification.  This is a start but still risky. Who wants to buy the untested batch?

Look for companies that test every batch. You should find this information on their website.  Look up your supplement’s website and read about how they conform to cGMP.  Some reputable retail lines are: Now Foods, Herb Pharm, Jarrow, New Chapter, Nature’s Way and Carlson’s.

Emerson Ecologics and Natural Partners are online companies that sell professional and retail supplements. Want to be a cheater? Save some time and browse their products to find reputable brands.


Want to save even more time (and money)?

Sign up for a Wellevate or FullScript account under my resources tab. High-quality clinical-grade supplements that I offer readers of my blog at patient pricing (cheaper than Amazon).


More Free Resources

Operation Supplement Safety.  If you’re a workout or health freak, this is your rabbit hole. There is a TON of free information here. Initially created because a high number of our servicemen were taking dangerous or off-brand supplements. But has become so much more. Need apps? They have them too: https://www.opss.org 

Natural Medicine Database. Be one of the brainy kids with this user-friendly resource normally used by professionals. 

http://naturaldatabaseconsumer.therapeuticresearch.com/

FDA’s list of frauds and scams.  A collection of nightmares. https://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/MedicationHealthFraud/default.htm

FDA’s main supplement site. https://www.fda.gov/Food/DietarySupplements/default.htm

And as always, talk to your healthcare practitioner before taking any supplements. 

This cannot be understated

 

References

https://ods.od.nih.gov/About/DSHEA_Wording.aspx

https://www.fda.gov/Food/DietarySupplements/ProductsIngredients/default.htm

http://www.npainfo.org/NPA/Advocacy/FederalGMPsforDietarySupplements.aspx

https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm238182.htm

https://www.fda.gov/Food/DietarySupplements/UsingDietarySupplements/default.htm

https://ods.od.nih.gov/HealthInformation/DS_WhatYouNeedToKnow.aspx

http://www.gao.gov/assets/660/653113.pdf

Center for Food Safety and Applied Nutrition. (2014, January). Constituent Updates - FDA Initiates New Online Reporting Method for Dietary Supplement Adverse Events to Facilitate Reporting. Retrieved from https://www.fda.gov/food/newsevents/constituentupdates/ucm381317.htm

https://www.fda.gov/food/newsevents/constituentupdates/ucm381317.htm

http://lpi.oregonstate.edu/mic/vitamins/vitamin-K#coagulation

http://lpi.oregonstate.edu/mic/vitamins/vitamin-A#toxicity

Americans Spend $30 Billion a Year Out-of-Pocket on Complementary Health Approaches. (2016, August 02). Retrieved from https://nccih.nih.gov/research/results/spotlight/americans-spend-billions

https://www.naturalproductsinsider.com/news/2013/05/fda-gmp-inspectors-cite-70-of-dietary-supplement.aspx

https://www.facs.org/education/patient-education/patient-resources/prepare/medications

https://www.fda.gov/ICECI/enforcementactions/warningletters/default.htm

https://www.accessdata.fda.gov/scripts/importrefusals/

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.