A few months ago, some of us attended a workshop on hormonal treatments and Endometriosis. It was presented by Dr. Sally Rafie of The Pharmacist’s Clinic. We’ve all heard the term, “Big Pharma,” and the lobbyists, money, and the-big-push that comes with pharmaceuticals and their respective manufacturers. But at this workshop, I learned of the term “Big Supp.” And went “oooooooooooooooooooh” – never once had I thought of the machine that drives the supplement industry. Nor the regulations that they are, or aren’t, forced to adhere to.
Someone recommends I take something? I may do some precursory research, but nothing in depth. And I generally will try it…I am always wary of the snake oils, though – the “specifically-marketed-to-relief (fill in the blank)” pills, oils, tinctures, shakes, etc.
So, today, I delve into the dietary supplement industry. What are the driving forces behind the industry. What regulations, if any, exist to ensure the safety of the consumer? Is there a great big corporate pyramid with some dark and sinister Villain perched on top? Or is it all just clean-livin’ hippies out to help the world? Let’s find out!
“Dietary Supplements” according to the Federal Trade Commission are: vitamins and minerals, amino acids, enzymes, herbs, animal extracts, and probiotics. The FTC put out an infographic about dietary supplements, which you can view by clicking here.
According to some sources, the supplement industry rakes in $30-120 billion a year in the US alone. Nutraceuticals World states that the supplement industry creates 754,000 jobs and pays out $38 in salaries/wages. And that the dietary supplement industry constantly fights the FDA’s regulations and policy change.
The US Food & Drug Administration does not regulate the supplement industry like they regulate the pharmaceutical industry. Supplement manufacturers do not need to seek FDA approval or prove to the FDA that their products contain the ingredients they say it does, nor do they have to pass safety or efficacy tests. They can simply put their product on the market. Sometimes, this leads to contaminated or unsafe products. They’re supposed to report to the FDA any adverse events (people complaining of harmful side effects, etc.). There will be times where consumer tests may red-flag supplements and the FDA steps in, finding violations.
Dietary supplements are a political hot-bed, too. There’s an ongoing history of political contributions, supposedly in an effort to win political favor over policy changes. In the past, democrats have been seeking to have the supplement industry regulated like prescription drugs; however, there has been strong opposition from supplement manufacturers. In 2015, over $3,000,000 was raised in lobbying efforts.
In 1994, the Dietery Supplement Health Education Act came into effect. In short, dietary supplements fall under the “food” category, rather than the “medicine” category. This means manufacturers must report all ingredients/allergens on a label, that the ingredients are safe for consumption, and that the amount of content claimed is at least as much as the amount identified on the label (it can be more). It also means that the products aren’t held to the same standards as pharmaceuticals: safety and efficacy do not need to be proven to the FDA, nor does it need to pass an approval process.
Not only is it an under-regulated industry (regarding health claims and consumer safety), but some supplements may have negative interactions with other medications (such as antibiotics, birth control, or blood pressure medication). Reportedly each year 23,000 people end up in the Emergency Room because of a supplement they took, and adverse reactions. I cannot stress enough to please talk to your physician before beginning a supplement.
In 1995, the FDA created the Office of Dietary Supplement Programs. The ODS is tasked with promoting the scientific study of dietary supplements. They are presently working on publishing their strategic plan for 2015-2020. The ODS’s mission statement is, “to strengthen knowledge and understanding of dietary supplements by evaluating scientific information, stimulating and supporting research, disseminating research results, and educating the public to foster an enhanced quality of life and health for the U.S. population.”
In 2006, the Dietary Supplement and Nonprescription Drug Consumer Protection Act came into existence. Manufacturers must report any adverse events/reports to the FDA. The FDA also encourages consumers to report any adverse events they may have while using dietary supplements.
In 2007, the Current Good Manufacturing Practices took place – invoking standards in an effort to ensure quality throughout the manufacturing, processing, labeling, and storing of supplements. It took full effect in June 2010.
From 2008-2012, the FDA found that nearly half of the 450 manufacturers inspected violated manufacturing rules. It could have been as simple as using the wrong phrasing on a bottle (making a claim to treat/cure a condition), having unclean manufacturing/storage facilities, or even using incorrect/undisclosed ingredients.
In 2008, over 200 people were treated for toxicity due to Total Body Formula’s supplements – it turned out that the products had 200 times the labeled dosage of selenium, as well as heightened levels of chromium, which can lead to toxicity poisoning. Many people reported symptoms of hair loss, fingernail discoloration, muscle and joint pain, gastrointestinal issues, and many missed work because of their symptoms. A lawsuit was filed in 2008, and completed in 2012; however, the settlement terms were confidential. Total Body Formula supplements were manufactured by TexAmerican Food Blending (Arkansas) and Wright Enrichment (Louisiana). According to TBF’s attorney, Rod Cate, “They have nothing to do with the manufacturing process. [Total Body] relies upon the manufacturers to do it correctly.” Where were the checks and balances? Oh, that’s right : they don’t exist for the supplement industry.
In 2009, the FDA filed a complaint against Quality Formulation Laboratories, Inc.; American Sports Nutrition, Inc.; and Sports Nutrition International, LLC, for manufacturing and storing products in “filthy conditions,” which may allow allergens to enter the products. An inspection found live (and dead) rats in the facility (including a dead rat cut in half on the blending platform), rodent urine & feces, and holes gnawed through product packaging. The companies were also including milk ingredients in their products, but failed to disclose such on their labels – which could be a major allergen problem for some folks. Finally, it was discovered that equipment was not cleaned between batches, allowing for contamination. In 2010, the US District Court shut down the three businesses for their violations; however, the owners of the three businesses were continuing to operate in 2011. They were found guilty of contempt and were each sent to Federal Prison.
In 2011, the FDA filed an injunction against ATF Fitness Products and Manufacturing ATF Dedicated Excellence, aka MADE, (both companies owned by the same man) for substituting ingredients and failing to update the labels on their products. Additionally, they failed to report to the FDA adverse reactions/events, including one consumer suffering a heart attack. ATF exclusively purchased their products from MADE. Some of the products they manufactured and distributed were: Sci-Fit and Nature’s Science. In 2012, they were permanently shut down. ATF Fitness Products filed for bankrupcy in 2012, MADE filed for bankruptcy in 2013, and Mr. Vercellotti, the individual owner of both companies, filed for bankruptcy in 2013.
In February 2015, the New York Attorney General’s office accused Walmart, Target, CVS, and GNC of selling fraudulent/dangerous supplements. The majority of the products tested from these retailers did not contain the ingredients identified on the label. Many also contained a majority of fillers such as powdered rice, houseplants, beans, peas, and asparagus. For example, a ginkgo biloba supplement purchased at Walmart claimed to be gluten- and wheat-free, but ended up just containing powdered radish, houseplant, and wheat. Ginseng pills purchased at Walgreens were made of only garlic and rice; it contained no ginseng. Many retailers stated they were going to pull the items from their shelves. Others stood by the integrity of the manufacturing and testing of the supplements. GNC agreed to now use DNA barcode testing to “authenticate plants used in supplements and adopt new testing standards to prevent contamination. The agreement also imposed reforms to improve transparency for consumers and to promote consumer safety.”
Then in September 2015, the New York Attorney General’s office was at it again. This time they found that 13 manufacturers of “devil’s claw” supplements were using the wrong plant altogether! Some of the manufacturers included The Kroger Co. (with Vitacost.com – where I buy my supplements…crap), Now Foods, Nutraceutical International, and Nature’s Way. Nature’s Way responded to the A.G.’s office, stating they would refund anyone who purchased their product during a certain period of time, and to employ better verification processes.
In November 2016, the FDA announced that Raritan Pharmaceuticals, Inc., had voluntarily recalled some of their homeopathic products because they might contain more Belladdona, a potentially fatal poison, than labeled or intended. These products included baby teething tablets and a liquid ear relief treatment.
Also in November 2016, the Consumer Labs tested various potassium supplements and found one brand had arsenic present! A daily serving of the potassium tablets was found to contain higher levels of arsenic than allowed by the EPA in a full liter of drinking water. Think it was the cheapest available supplement? Nope! Of all the products tested for arsenic, the potentially-toxic “winner” was the most expensive! Unfortunately, the brand name was not made available without having a paid membership with Consumer Lab.
On December 1, 2016, the FDA announced that Ultimate Body-Tox was recalling their Ultimate Body Tox PRO tablets since it contained an undeclared ingredient: sibutramine. Sibutramine was declared unsafe in the US in 2010 and removed from the consumer market. It has been known to cause an increase in pulse rate and blood pressure, which may be a risk factor for those with heart problems. Not only did their dietary supplement contain an known unsafe ingredient, but the manufacturers failed to identify the ingredient on the label!
This year, India has enacted new regulations that supplements can no longer be sold as medicinal and must feature a “health supplement” label and an advisory warning that it is not intended for medicinal use. Furthermore, the ingredients cannot exceed daily allowances mandated by the Indian Council of Medical Research. Supplements are also restricted by age : only people over 5-years-old may be given supplements. These regulations are scheduled to take full effect January 2018.
New Zealand’s government is presently working on clarifying the labels used on natural health products (NHPs), as well as limiting ingredients and dosages.
How can you be sure that the supplements you’re taking are a) what they claim to be and b) safe? Frontline put together a great list of five steps you can take to look a little deeper into your supplements. Read their article here. These tips also include checking the FDA’s webpage for adverse effects/reactions to the supplement(s).
There are companies out there that independently test and vouch for dietary supplements. ConsumerLab conducts independent tests and publishes results about many different products, including dietary supplements. Unfortunately, you must be a member to review the results of those tests. NSF International is another company that conducts independent tests. US Pharmacopeial Convention is a non-profit organization that tests the integrity of dietary supplements. For a list of USP-approved supplements, click here. These companies offer a “seal of approval” that you can find on the packaging of supplements. Be advised, though, that manufacturers pay these independent testers to review their products and receive that seal showing the product contains what it says it contains – it does not mean the product is safe for consumption, or that it will do what it claims. Plus there’s always the chance for biased results when someone is paying for a service…
AND, do your own personal research. I was told to take flax seed oil as a great Omega-3 fatty acid to help combat the inflammation of Endometriosis. And, without research anything, I did. I was excited to try this new thing that may help with my pain. Did I have adverse reactions? None that I could feel…but I did learn much later that flax seed contains phytoestrogens which may boost my estrogen levels and adversely influence my Endometriosis. Whelp. So I moved on to krill oil…but now I want to research ALL of the supplements I’m taking, one by one.
Also, don’t be afraid to ask your physician their opinion on products. I told my gastroenterologist that I was taking digestive enzymes and probiotics daily. He asked if they made me feel any better – and I let him know that I wasn’t any better or any worse. So he suggested I stop taking them, stating that my body creates enough digestive enzymes and probiotics on their own. So, I tried the test : stop them for a few weeks, see how I feel. If no better or no worse, might as well save me the $30 a month that I was throwing into those supplements. And do you know what? I still feel great, having stopped them nearly a year ago.
I also asked my gynecologist his thoughts on resveratrol for adhesion prevention. He believes there isn’t enough science to back the claims AND stated the dosages required would be incredibly high. He encouraged me to save my money, maintain a healthy diet, exercise, and keep positive thoughts. The decision was totally mine; however, and I chose to save my money. Does this mean I’ll never buy a new supplement ever again? Hell no. I’m presently looking into an enzyme that helps a fellow EndoSister immensely – I’m just going into this with a more informed outlook…
All that being said, though, if the supplements you are taking make you feel better, continue what you are doing! That truly is what’s important. But…do your homework and research! Talk to your physician. And check for consumer complaints…
I had no idea the dietary supplement industry was so under-regulated. I knew they weren’t held to the same approval standards, but didn’t realize it was such a free-for-all. Do I believe Big Supp exists? I sure do… But I shall become the informed consumer, damn it!
I hope you do, too.
*Updated December 1, 2016*
Chicago Tribune – (Article; June 2012) Dietary Supplements: Manufacturing Troubles Widespread, FDA Inspections Show
CNN – (Article; Nov. 2016) Homeopathic Kids’ Products Recalled Due to Belladonna
Consumer Lab – (Press Release; Nov. 2016) ConsumerLab.com Finds Arsenic in Testing of Potassium Supplements
Consumer Lab – (Press Release; Nov. 2016) Seller of Mineral, Joint Supplements and More Warned for Manufacturing Violations, Drug Claims
Council for Responsible Nutrition – Dietary Supplement and Food Regulations Compared
CourtDrive – ATF Fitness Products, Inc.
Federal Trade Commission – Dietary Supplements
Forbes – (Article; Dec. 2011) Prison for Sellers of Dietary Products Contaminated by Rodents and Milk
Frontline – (Article; Jan. 2016) Five Questions to Ask When Considering Health Supplements
HealthWyze – (Blog; March 2010) Evaluating the Evaluators from Consumer Lab
India Today – (Article; Nov. 2016) FSSAI Sets Rules to Check Health Supplement Mis-Labeling
Inforuptcy.com – MADE
Mad in America – (Article; Nov. 2016) Have you Ever Wondered Why Labels on Suppelements are So Vague?
National Institutes of Health Office of Dietary Supplements – Dietary Supplements: What You Need to Know
National Institutes of Health Office of Dietary Supplements – Mission, Origin, and Mandate
Natural Products Insider – (Blog; 2011) FDA Slams AFT for cGMP Violations
New York Attorney General – (Press Release; Sept. 2015) A.G. Schneiderman Issues Cease-and-Desist Letters to 13 Makers of Devil’s Claw Supplements Marketed to Arthritis Sufferers
New York Times – (Article; Feb. 2015) New York Attorney General Targets Supplements at Major Retailers
New York Times – (Article; Nov. 2016) Which Supplements, if Any, May be Worth Your Money
NSF – Dietary Supplement Safety
Nutraceuticals World – (Article; June 2016) Supplement Industry Contributes $122 Billion to US Economy
OpenSecrets – Nutritional & Dietary Supplements lobbying information
Pharmavite – (.pdf handout; 2015) How Dietary Supplements are Regulated
Pittman Dutton & Hellums – Total Body Formula no RX for Health, Sickens 197
Plainsight – (Court docket) In Re: Total Body Formula Products Liability Litigation MDL 1985
Regulatory Affairs Professionals Society – (Article; Dec. 2015) FDA Unveils New Office of Dietary Supplement Programs
ScienceBlogs – (Blog; July 2012) Dietary Supplements: Scary Substances Manufactured Under Scary Conditions
Seminole Voice – (Article; Nov. 2016) Not All Supplements are What They Claim to Be
STAT – (Blog; Nov. 2015) Experts Debate: Do We Need Tougher Regulation of Dietary Supplements?
Trib Live – (Article; May 2012) Federal Agents Mum on Raid at Closed Oakmont Factory
US Food & Drug Administration – Dietary Supplements Guidance Documents & Regulatory Information
US Food & Drug Administration – (Press Release; Nov. 2011) FDA Takes Enforcement Action Against Pennsylvania Dietary Supplement Maker
US Food & Drug Administration – (Press Release; July 2009) FDA Takes Enforcement Action Against Three New Jersey Dietary Supplement and Protein Powder Manufacturers
US Food & Drug Administration – (Press Release; March 2008) FDA Warns Consumers About “Total Body Formula” and “Total Body Mega Formula” Distributor Recalls Dietary Supplement Products After Reports of Adverse Reactions
US Food & Drug Administration – (Database) For Consumers: Dietary Supplements
US Food & Drug Administration – (Article) How to Spot Health Fraud (interestingly enough, it’s under the “Bioterrorism and Drug Preparedness” category)
US Food & Drug Administration – (Press Release; Nov. 2016) Raritan Pharmaceuticals Inc. Issues a Voluntary Nationwide Recall of Products Containing Belladonna Extract Due to the Possibility of the Presence of Belladonna Alkaloids
US Food & Drug Administration – (Press Release; Dec. 2016) Ultimate Body Tox PRO: Recall – Undeclared Drug Ingredient
Vanguard – (Article; Nov. 2016) WARNING! Your Dietary Supplements May Not be Living Up to Their Claims
~ Again, I am a layman. I do not hold any college degrees, nor mastery of knowledge. Please take what I say with a grain of salt. If curious, do your own research Validate my writings. Or challenge them. And ALWAYS feel free to consult with your physician. Always. Yours ~ Lisa