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What You Probably Don’t Know About How Supplements are Regulated


One of the most common reasons you’ll hear for avoiding dietary supplements is that they are not “regulated by the Food and Drug Administration.”

Some people have this perception that supplements and natural health products are a complete sham. They think it is all witch doctors and snake oil salesmen peddling miracle cures without any scientific evidence.

But that is simply not the truth…

While there are certainly scam artists working in the black market of the supplement industry, and while it’s true that nutritional supplements don’t undergo the exact same scrutiny as pharmaceutical drugs, the supplement industry actually is regulated by the FDA. The biggest difference is that supplements do not need to be FDA approved.

However – as you’ll see if you keep reading – that may not mean a whole awful lot when it comes to your safety…

How the FDA Regulates Dietary Supplements

So if the FDA is involved with regulating supplements – where did the confusion come from?

In 1994, President Bill Clinton signed legislation into law known as Dietary Supplement Health and Education Act (DSHEA). This law classified supplements – including things like vitamins, herbs, minerals, probiotics and enzymes as foods rather than drugs.

The U.S. Government defines a dietary supplement this way in the DSHEA:

“A dietary supplement is a product taken by mouth that contains a ‘dietary ingredient’ intended to supplement the diet. The ‘dietary ingredients’ in these products may include: vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites. Dietary supplements can also be extracts or concentrates, and may be found in many forms such as tablets, capsules, softgels, gelcaps, liquids, or powders.”

Under this law, a supplement manufacturer would still need to acquire FDA approval if a product it markets contains what qualifies as a “new dietary ingredient.” That basically means any ingredient that was not sold or marketed in the U.S. before 1994.

Another aspect of DSHEA is that it transferred the primary responsibility for determining safety and efficacy (validity of claims made about the product) to the firm or manufacturer of the supplement.

That’s what makes most people unsure about taking supplements, which is somewhat understandable. It does seem to open the door for making false and misleading claims about how a product will affect an individual’s health.

But the FDA continues to keep a watchful eye on the supplement industry.

It’s not the Wild West that some people make it out to be. There are still hoops supplement manufacturers need to go through before bringing a product to market – many of them defined within DSHEA.

Here are just some of the examples:

  1. Dietary Supplements must be made under current GMP guidelines (Good Manufacturing Practices)
  2. Supplement manufacturers must register every facility with the FDA
  3. All ingredients must be safe for consumption
  4. Labeling (including product descriptions) may not claim to mitigate, cure, prevent, diagnose, or treat any disease.
  5. Disclosure of key allergens is required
  6. Labeling must include contact information for reporting adverse events
  7. False or misleading claims are prohibited

Plus, in 2007, the FDA published a comprehensive list of guidelines for supplement makers that are intended to ensure the identity, purity, quality, strength and composition of products offered.

Besides the FDA, another organization that plays a role in the supplement industry is the United States Pharmacopeia. If a natural health product carries the USP mark – that means the organization has tested and verified the manufacturing process, ingredients and potency of the supplement.

The Food and Drug Administration may also analyze the contents of dietary supplements. However, the agency says that because of limited resources…

“…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 remaining funds are used for routine monitoring of products pulled from store shelves or collected during inspections of manufacturing firms. The agency does not analyze dietary supplements before they are sold to consumers.”

To find out more about how the FDA regulates dietary supplements you can visit the FDA website.

What Does FDA Approved Really Mean?

The FDA certainly does have a lot of work to do – and it’s a crucial job. It must protect consumers like us from getting ripped off  by drug makers – and even more importantly – from things that could be potentially harmful.

It is true that pharmaceuticals and over-the-counter medications may be subject to more oversight than dietary supplements.  However, it’s also important to realize that just because a drug wins FDA approval – that does not necessarily mean it will be 100% safe.

Let’s look back at just a few tragic examples of FDA-approved drugs gone wrong…

1. Vioxx

You’ve probably heard about this fiasco – since it was the one of the most controversial scandals in the FDA’s history.

The FDA approved Vioxx in 1999 as an anti-inflammatory drug intended for conditions like arthritis and migraines.

It was pulled from the shelves after a mountain of evidence indicated Vioxx was causing serious heart problems. A subsequent FDA study found that Vioxx could be blamed for 27,000 heart attacks and cardiac deaths.

The sad thing is that Vioxx was on the market for more than five years and was prescribed to more than 20-million people before the right decision was made.

2. Meridia

Also known as sibutramine, Meridia was marketed as a prescription weight loss drug and appetite suppressant from 1997 through 2010.

The FDA recalled Meridia after multiple studies and reports linked it to cardiovascular problems. One of those studies published in the New England Journal of Medicine suggested the drug increased the risk of stroke, heart attack, cardiac arrest or cardiac death by 16%.

The drug was also pulled after concerns about its minimal efficacy (AKA it didn’t work that well). Of course, this all came about after Meridia became FDA-approved.

3. Zocor

Many FDA-approved cholesterol drugs have been linked to startling, negative side effects. That includes Zocor or simvastatin – which  is intended to prevent heart disease.

While described as rare, side effects from Zocor included joint pain and muscle degeneration including a serious condition known as rhabdomyolysis – which can lead to kidney failure.

All of that prompted the FDA to issue warnings for those taking high doses of simvastatin.

Now some would say that the recalls and warnings issued by the FDA against potentially harmful  medications is evidence the agency really is doing its job and that the system works. But you still have to question why these issues weren’t noticed sooner – especially if traditional drugs endure so much more scrutiny than dietary supplements.

Drug Deaths vs. Supplement Deaths

Notable natural health expert Dr. Joseph Mercola pointed out in a 2012 article that fatalities from drugs far outweigh those believed to be caused by vitamins and supplements.

Mercola cites information from the U.S. National Poison Data System – which found that in 2010 not a single death could be blamed on someone taking a dietary supplement. That’s with more than half the U.S. population taking supplements regularly – amounting to more than 60-billion doses per year.

Mercola calls that a pretty amazing safety record.

But in contrast – Mercola says traditional drugs typically cause more than 125,000 deaths per year. And that’s when these medications are being properly prescribed and used as directed. (Read more on Mercola.com)

What it All Means for Natural Healthy Concepts and You

One of my responsibilities here at Natural Healthy Concepts is writing product descriptions you see on the website.

Very often, the descriptions we get from manufacturers are written for healthcare practitioners and not consumers or end users. That means there’s a lot of industry jargon or scientific language, which can be hard to understand or irrelevant to people like you.

What I and others at NHC try to do is re-write those descriptions so they make sense. We want you to be able to understand the uses and potential benefits of products – as well as warn you about taking something you shouldn’t.

But in our writing (because of FDA rules)  we cannot ever say that a supplement can prevent a health issue – even if it’s true! This creates a bit of a conundrum since much of natural health and nutrition is based around concepts of preventative medicine. The goal is usually to keep you healthy – or address the cause of the problem rather than the symptom.

In many cases, we cannot even mention the name of the condition that a supplement may improve. If a product is formulated to help with arthritis – we can only say it “may relieve joint pain” or that it “supports healthy joints.” That’s as close as we can get to suggesting it is something for people struggling with arthritis.

Even when an ingredient has been clinically proven to do what it claims – if it is classified as a dietary supplement – we still cannot make that claim. For instance, it is widely accepted that melatonin is something that can help people who have difficulty sleeping. But those of us who offer supplements to the public can’t even make the claim that it can treat jet lag.

Supplement manufacturers who make claims the FDA considers to be too strong often receive warning letters and large fines.

At least from my perspective – saying that the FDA does nothing to regulate supplements is pretty far-fetched. And in my personal opinion, some of these restrictions only add to the confusion – as well as possible risks. How can consumers decide what supplements to take if it is unclear what each product is intended to help?

The Bottom Line

At Natural Healthy Concepts – we believe that you should have the right to make your own decisions about your health. That’s why our motto is “Your health is the best investment you’ll ever make.”

We also believe that you should be able to find supplement manufacturers and natural health stores that you can trust.

This is why Natural Healthy Concepts offers many brands which can only be purchased through a licensed healthcare practitioner. We are able to bring these brands to our customers because we are owned and operated by certified nutritionist, Theresa Groskopp.

We also strive to educate consumers like you through this blog, informative articles on our site, our newsletter and even our product descriptions.

Even so – it is important to discuss supplements you choose to take with your doctor and other healthcare professionals with which you consult.

It’s true that you could get swindled by someone offering supplements – especially if you’re trying to get them on the cheap or from the black market. That’s a good reason not to shop for supplements on places like Amazon.com. Some of these suppliers are up to no good, and that’s a big part of what has lead to mistrust in the natural health industry.

Unfortunately – greed and deception are part of both the worlds of traditional drugs and natural health. Both sides have lobbyists in Washington, D.C. trying to get things to swing in their favor. In both cases, there are people serving the “Almighty Dollar” when they should be serving you.

But there are good guys out there too! At Natural Healthy Concepts – we promise you can trust us to be one of them.