The FDA does regulate nutritional supplements (kinda).
The supplement industry has long been defined and regulated by the FDA under two statutes of federal legislation: the Food, Drug and Cosmetic Act, and the Dietary Supplement Health and Education Act (DSHEA).
Before you breathe a sigh of relief, you need to know there are important problems with how they regulate it:
- A team of 25 people in the FDA are responsible for managing an estimated 4,000+ supplement companies selling over 80,000 products in a $30 billion industry.
- “They only inspect a small number of facilities relative to the amount of supplements being sold,” said Laura MacCleery, director of regulatory affairs at the Center for Science in the Public Interest. “They find significant levels of problems in the few facilities they do inspect.”
- Data from the Government Accountability Office, for example, showed that between January and September of 2012, the agency inspected roughly 18 percent of known manufacturers at the time.
- Of those inspected, 70% of supplement firms were cited for violating regulations intended to ensure products are safe and contain the ingredients that are listed on the labels.
- The FDA isn't responsible for proving any product is safe, pure, effective, or even meets label claims before you buy it.
- Here's a "fun" example to bring this into perspective: the government requires barbers and hair dressers to be licensed and thus approves their ability to cut your hair before you give them money, right? In the world of supplements, anyone can manufacture, test, and/or sell supplements without a licence or without any qualifying credentials whatsoever.
Because of loose and unenforced regulations...
You can (and likely do) purchase products that are counterfeit, laden with heavy metals, tainted with pesticides and toxic mold, or processed with toxic chemicals with no consequence until enough people get sick and report it.
Get ready. You're not going to like this. The unpleasant truth is that supplement companies of all sizes sell us what we would never buy if we knew what was really inside the capsule.
How common is this, you ask?
Obscenely common. For example, in one study of 12 companies tested:
- Most (59%) of the products tested contained DNA from plant species not listed on the labels.
- One-third also contained contaminants and or fillers not listed on the label and some of the contaminants found pose serious health risks to consumers.
- Product substitution (counterfeit herbs) appeared in 30/44 of the products tested.
- 3 of the 12 companies sold products for which no ingredients could be recognized by testing.
- Leaving only 2 of the 12 companies tested selling authentic products without substitutions, contaminants, or fillers.
You cannot rely on government regulators to keep supplement companies honest or their products pure.
The vast majority of supplemental vitamins, for example, are artificial.
If you take a multivitamin of any kind, go grab it now and read the Supplement Facts label. Odds are, yours may look something like this:
Do you see chemical sounding names in parenthesis next to the words "vitamin"? Look for words like "ascorbic acid" and "pyridoxine hydrochloride." Those are artificial vitamins created in a factory, made from and processed with toxic chemicals.
An honest label would read like this...
If that label had the actual ingredients for what the vitamins are made of, it would read like this:
Ingredients: coal tar derivatives, hydrochloric acid, acetonitrole with ammonia, 3-cyanopyridine, condensed isobutyraldehyde with formaldehyde, petroleum ester, phytin hydrolyzed with calcium hydroxide and sulfuric acid, acetylene, formaldehyde, cobalt reacted with cyanide, GMO corn dextrose processed with GMO bacteria and acetone (etc.)...
The truth is, even though they're labeled "vitamins," they're actually closer to pharmaceutical drugs than they are to nutrients.
The evidence is clear: artificial "vitamins" are actually known to harm your health and have in fact never been clinically demonstrated to improve your health. In fact to the contrary, artificial vitamins can increase your chances of developing prostate cancer, cardiovascular disease and cancer in women, heart-disease and death, and even elevate the risk of autism in yet-to-be-born children...
“If it's a plant, eat it. If it was made in a plant (factory), don't.” - Michael Pollan
What about Fish Oil?
Fish oil comes from fish, so it's natural, right? Well, most fish oil is refined and stabilized in order for it to sit outside of refrigeration for years without going rancid. How do they preserve it? The majority of fish oil products are heavily processed, boiled, and treated with industrial solvents, transforming them into semi-synthetic oils: a man-made combination of GMO corn ethanol and EPA/DHA. It's a process called "molecular distillation" and though it cleanses the oil of heavy metals and PCBs, these highly processed fish oils can negatively affect your health. However, eating contaminant-free oily fish is well researched to affect your health positively.
Even though fish oil is typically a heavily processed industrial food, fish oil supplements continually fail to pass important markers for rancidity. One study showed, of 32 fish oils tested, 83% failed acceptable oxidation scores. Rancid oil means poor cellular health in your body.
What about Herbs?
Like EPA and DHA in fish oil, herbs are often 'extracted' using industrial solvents in order to produce concentrated supplements. Think of an extract like brewing tea - the healthy compounds are extracted from the plant into the water and the tea leaves are thrown away. The same is done with commercial herbal extracts, except replace the water with toxic industrial solvents. These extraction chemicals damage livers, kidneys, nervous systems, and cause cancer. Chemical extractions are cheaper and more powerful than natural ones, which is why most companies do it.
For example, one test done on Milk Thistle extract found these 30 hidden toxic chemicals: 1) 2-Methylbutane 2) Pentane 3) 2,2-Dimethylbutane 4) Acetone 5) 2,3-Dimethylbutane 6) 2-Methylpentane 7) Cyclopentane 8) 3-Methylpentane 9) Hexane 10) 2,2-Dimethylpentane 11) 2,4-Dimethylpentane 12) Ethylcyclobutane 13) 2,2,3-Trimethylbutane 14) 2,4-Dimethyl-1-pentane 15) 3,3-Dimethylpentane 16) 1-Methylcyclopentane 17) 2-Methylhexane 18) Cyclohexane 19) 2,3-Dimethylpentane 20) 3-Methylhexane 21) 1,1-Dimethylcyclopentane 22) 3-Ethylpentane and Benzene coelution 23) 5-Methyl-1-heptene 24) cis-1,3-Dimethylcyclopentane 25) trans-1,3-Dimethylcyclopentane 26) Heptane 27) 2-Methyl-2-hexene 28) Methylcyclohexane 29) Toluene 30) 4-Methyl-3pentane-2-one
The FDA doesn't require any supplement firms to test for residual solvents, which means most brands don't test for them, which leaves you exposed to serious risks.
You cannot assume supplements are natural or toxin-free just because you buy them in a health food store, aisle or site.
How common a problem is counterfeit, adulterated, and contaminated products?
A team of researchers set out to test 30 commonly used herbal products for the presence of mold. They identified mold in 90% of the samples, and in 70% of the samples the mold levels exceeded acceptable levels. Harmful molds were identified in around 43% of the samples, reports Medical News Today.
“There is a major problem in the global herb and dietary supplements industry in which there appears to be a persistent availability of adulterated herbs, herbal extracts, essential oils, and other plant-derived dietary ingredients,” said American Botanical Council's Founder and Executive Director Mark Blumenthal.
"Federal inspections of companies that make dietary supplements reveal serious and widespread manufacturing problems in a multi-billion dollar industry that sells products consumed by half of all Americans," reports The Chicago Tribune.
Nearly all of the herbal dietary supplements tested in a Congressional investigation contained trace amounts of lead and other contaminants. 16 of the 40 supplements tested contained pesticide residues that appeared to exceed legal limits, reported The New York Times.
"In fact, an estimated 70-90% of Dietary Supplement Manufacturers do not test," reports New Chapter's Science & Innovation Team.
Herbal products and botanical ingredients in general are highly suspect.
These 20 herbs are on The American Botanical Council's "known or suspected adulterated botanicals" list: Cranberry, Black Cohosh, Echinacea, Goldenseal, Saw Palmetto, Aloe, Ginkgo, Pomegranate, Bilberry, Skullcap, Grapefruit Seed Extract, Ginseng, Ashwagandha, Arnica, Maca, Tea Tree, Grapeseed Extract, Chaste Tree Berry, Valerian Root, and St. John's Wort.
The propensity for adulteration of ginkgo, for example, is “extremely high”—as high as 60 percent to 70 percent of products on shelves, according to Roy Upton, Executive Director of the American Herbal Pharmacopoeia.
With saw palmetto [...] there’s up to 60 percent or 70 percent potential for adulteration, says Roy Upton.
A study at Rutgers University tested 21 commercial grapeseed extract products for identity. Of those 21, NINE products contained peanut skin extract, not grapeseed extract.
Of 37 commercial St. Johns Wort supplements tested, four in ten contained synthetic dyes and/or counterfeit herbs.
Over 1000 supplements have been found to contain prescription or experimental drugs - Consumer Reports
You can safely assume most supplements are not safe.
From food or not from food?
Because many supplement companies falsely market their products as "food-based" rather than spend the extra money to actually make them food-based, shopping for natural supplements can be very confusing.
Imagine you are at the store to buy a vitamin. You pull the product shown below off the shelf and read the label. Would you say the vitamins in this product are from food or are they artificially sourced?
If you answered "from food," guess again.
Now see what a multivitamin supplement facts panel that sources its nutrients from food looks like:
A supplement can claim to be natural or raw or whole food when it isn't.
Let's return to that store shelf and this time you are after some calcium. You read the container to learn more. Do the words lead you to believe the calcium comes from food?
Is this calcium actually food-based? No. This calcium is mined industrially from rock (limestone) and synthetically combined with chemicals. Frustrating, right?
Calcium carbonate is just chalk - like the kind used on chalkboards. Calcium Amino Acid Chelate is that same chalk calcium synthetically combined with a synthetic amino acid and isn't found anywhere in nature. Calcium Citrate-Malate is the same, but with added citric & malic acids.
Misleading advertising is a game to marketers but is a danger to those of us who care about our health.
Bonus fact: chalk-based calcium formulas like this one are known to cause heart disease.
Health food store clerks, for example, are trained by the very industry that has a lot to hide from you.
With an estimated 70-90% of dietary supplement manufacturers not properly testing their products, you need an informed gatekeeper to help you navigate the perils of a lightly regulated supplements industry. We often look to health food store personnel, internet health gurus, and health care professionals to help us make informed supplement decisions, but if their information comes from the companies deceiving us, how can we trust their recommendations?
Health food store personnel don't have to hold any degrees or certifications to recommend supplement regimens, and the majority of their product expertise comes from sales-focused, brand-sponsored trainings. This creates a commercial bias that puts your health at risk.
Major vitamin retailers and grocery stores do not require Certificates of Analysis (test results that are only way to prove a product is safe) in order to sell products to you, which makes you vulnerable to the problems explored in this presentation.
If you shop online for your supplements, you are even less protected.
Certificates of Analysis are the closest thing to a legitimate answer to the question: What's inside the bottle? The gold-standard certificates are third-party tests by an independent lab, removed from the commercial bias of the supplement distributor.
Chiropractors, acupuncturists, and naturopaths often recommend supplements.
They typically work with a "professional line" of products that can typically only be purchased in their office or from their website. But are these products superior in quality to those found in supplement stores?
With very few exceptions, professional brands use the same suppliers of raw materials as the rest of the supplements industry. Besides formulation differences, the only real difference is that their products are marketed to appear exclusive.
Independent tests run on professional lines indicate they have the same problems with contamination and adulteration. One study shows that all 28 samples of 90% curcumin turmeric extract products tested contained unfathomable levels of a dangerous carcinogen, 1-2 dichloroethane, including all professional grade products. Some were contaminated at levels 172,800% over legal limits, yet were available for purchase.
When a practitioner offers a single line of products, their objectivity is compromised and they have a conflict of interest. If you depend on products your practitioner recommends, ask to see a set of Certificates of Analysis.