My interest in dietary supplements goes way back—to when I was a kid barely into my double digits.
What I remember was secretly saving money to visit the drugstore and buy a supplement—a supplement promising me miraculous weight loss. My mom remembers it differently.
Apparently I first went to her with an ad I saw in some magazine. I’m sure I was seduced by the promising headline of miraculous weight loss. My mom however informed me not to pay attention to it—it was a rip off, a come on, it wouldn’t do anything for me. I didn’t believe her. What did she know?
I didn’t learn my lesson until decades later….with a much leaner wallet, but no leaner body. How much did I have to spend before I learned?
A few questions for you
If you take a dietary supplement do me a favor and grab your bottle. Take a look at it.
- Do you think it was approved by the FDA before you bought it?
- Was it required to be safe and effective before being sold?
Unlike food additives or drugs, supplements do NOT need to be proven safe and effective, nor do they need the Food and Drug Administration’s (FDA) approval before being sold.
Many believe that’s a good thing—limiting government’s involvement. I get that. Yet…
- How many resisted using a seat belt when it became law? (if you’re old enough to remember!)
- How many appreciate no smoking rules?
Since 1994 we’ve seen explosive growth of 475 percent ($8 billion to $46 billion)!
From 4,000 products to over 85,000.
Not one is required to be safe or effective. Not one.
What happened in 1994?
The Dietary Supplement Health and Education Act (DSHEA) was passed in 1994. I’ll explain in a moment, but first let me define what a dietary supplement is (according to DSHEA).
Dietary supplement defined
A product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients:
- Herbs or other botanicals
- Amino acids
- Concentrate, metabolite, constituent, extract or combination of above listed ingredients.
- Is intended to be taken by mouth, in forms such as tablet, capsule, powder, softgel, gelcap, bar, or liquid.
- Is labeled as being a dietary supplement.
Types of dietary supplements
- Micronutrients – vitamins & minerals
- Macronutrients – e.g., fatty acids (omega 3s – ALA, EPA, DHA), protein, amino acids
- Herbs (botanicals) – e.g., St. John’s wort, ginseng, ginkgo biloba
- Phytochemicals – e.g., lycopene, isoflavones, resveratrol
- Others – e.g., probiotics, glucosamine, melatonin, creatine, CLA, bee pollen
In other words if you take a multivitamin (regardless the form—pill, powder, liquid, chewable) it’s a dietary supplement. Other products you might have purchased:
- The probiotic promising amazing gut health.
- The herbal supplement you bought to improve your brain health.
- Most anything you purchased thinking it would increase metabolism, improve health, help weight loss, transform you into a lean, mean machine, etc.
- The fish oil*, vitamin D*, calcium, magnesium recommended by your physician.
- The keto supplement you recently purchased because you thought Shark Tank endorsed it.
- The products your nutritionist recommended (and might have sold you from her office) for menopause symptoms.
- The products a friend or family member is encouraging you to buy from the direct selling organization she is affiliated with.
*There is a form of fish oil (omega 3) and vitamin D available by prescription only. They are regulated like pharmaceuticals.
What is the Dietary Supplement Health and Education Act?
The bill that eventually became DSHEA was proposed by Senator Orrin Hatch of Utah in April 1993 and became law in October 1994. Its intention was to promote health of Americans by ensuring easier access to dietary supplements. It also shifted the burden of proof from the manufacturer to the FDA.
“Under (DSHEA’s) existing law, the FDA can take action to remove products from the market, but the agency must first establish that such products are adulterated (e.g., that the product is unsafe) or misbranded (e.g., that the labeling is false or misleading).” (fda.gov)
According to the 1994 law, a supplement is not required to:
- Have proof it works.
- Have proof ingredients listed on the bottle/package are there.
- Have proof ingredients are free of contamination.
- Provide warnings of potential side effects.
- Meet standards for potency or dosage.
Does that bother you? It does me.
- The net effect of DSHEA was a deregulation of the supplement industry. There are NO standards for potency or dosage and no requirements for providing warnings of potential side effects.
- Should a problem arise, the burden falls to the FDA to prove the supplement poses a “significant or unreasonable risk of illness or injury.” Only then will it be removed from the market.
- Although the law limits what can be said, many unsubstantiated claims are made ALL THE TIME by less-than-reputable manufacturers. It might be years before the FDA takes action.
- Although manufacturers are required to adhere to Current Good Manufacturing Practices (cGMP), compliance is questionable.
- Claims like diagnose, cure, treat, prevent a disease are not legally allowed for a supplement. The only rule is this statement: “This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.”
“Unlike drugs, supplements are not intended to treat, diagnose, prevent, or cure diseases. That means supplements should not make claims, such as ‘reduces pain’ or ‘treats heart disease. ‘Claims like these can only legitimately be made for drugs, not dietary supplements.” (fda.gov)
What to look for
There are seals of approval assuring product(s) do not contain contaminants and the ingredients listed on the label are in the product. The seals do not guarantee effectiveness. In other words, it may or may not ‘work.’
Organizations offering these programs include:
- ConsumerLab.com Approved Quality Product Seal
- NSF International Dietary Supplement Certification
- U.S. Pharmacopeia (USP) Dietary Supplement Verification Program
Their approaches are different and explained on each website.
A topic near and dear to me, this post about dietary supplements is one of several forthcoming. Since the 1990s and my days in grad school, I learned more than I ever imagined. It’s my mission to provide you unbiased relevant health and nutrition information so you can make educated decisions.
Please subscribe to my blog so you don’t miss my updates! I also speak on this topic to groups. Let me know if interested.
Remember, nothing takes the place of a nutrient-rich minimally processed plant-based diet.
- National Center for Complementary and Integrative Health
- National Institutes of Health – Office of Dietary Supplements
- Dietary Supplement Label Database
- LiverTox – livertox.nlm.nih.gov
Jennifer “Neily” Neily, MS, RDN, LD, FAND
Neily on Nutrition
Registered Dietitian Nutritionist
Wellcoach® Certified Health Coach
Fellow of the Academy of Nutrition and Dietetics
Photo credits: Neily on Nutrition, pixabay.com, ConsumerLab, U.S. Pharmacopeia
Website & blog: NeilyonNutrition.com