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When Dietary Supplements Are Used As Medicines

I was surprised to get this e-mail from a reader:

Surely, Dr. Hall, the public mania for nutritional supplements is baseless. All the alleged nutrients in supplements are contained in the food we eat. And what governmental agency has oversight responsibility regarding the production of these so-call nutritional supplements? Even if one believes that such pills have value, how can the consumer be assured that the product actually contains what the label signifies? I have yet to find a comment on this subject on your otherwise informative website.

My co-bloggers and I have addressed these issues repeatedly.Peter Lipson covered DSHEA (The Diet Supplement Health and Education Act) nicely. It’s all been said before, but perhaps it needs to be said again — and maybe by writing this post I can make it easier for new readers to find the information.

Food, Medicine, or Something In Between?

The FDA regulates foods and has been instrumental in improving the safety of our food supply. It regulates prescription and over-the-counter medications, requiring evidence of effectiveness and safety before marketing. Surveys have shown that most people falsely assume these protections extend to everything on the shelves including diet supplements, but they don’t.

Under the 1994 Diet Supplement Health and Education Act (DSHEA), a variety of products such as vitamins, minerals, herbs and botanicals, amino acids, enzymes, organ tissues, and hormones can evade the usual controls if they are sold as diet supplements. Under the DSHEA, the manufacturer doesn’t have to prove to the FDA that a product is safe and effective; it is up to the FDA to prove that it isn’t safe, and until recently there was no systematic method of reporting adverse effects (required reporting is still limited to serious effects like death).

So far the FDA has only managed to ban one substance, ephedra, and it took the death of a prominent sports figure and considerable skirmishing with the courts to accomplish that. Independent lab tests of diet supplements have found a high rate of contamination (with things like heavy metals and prescription drugs) and dosages wildly varying from the label. A striking example was Gary Null’s recent poisoning with vitamin D from one of his own products which contained 1,000 times the intended amount.

The FDA has issued rules on good manufacturing practices, but standardization is not required and it remains to be seen whether the new rules will effectively improve product quality. Read more »

*This blog post was originally published at Science-Based Medicine*

The Energy Drink

By Scott Gavura, BScPhm, MBA, RPh for Science-Based Medicine

My stimulant of choice is coffee. I started drinking it in first-year university, and never looked back. A tiny four-cup coffee maker became my reliable companion right through graduate school.

But since I stopped needing to drink a pot at a time, an entirely new category of products has appeared — the energy drink. Targeting students, athletes, and others seeking a mental or physical boost, energy drinks are now an enormous industry: From the first U.S. product sale in 1997, the market size was $4.8 billion by 2008, and continues to grow. (1)

My precious coffee effectively has a single therapeutic ingredient, caffeine. Its pharmacology is well documented, and the physiologic effects are understood. The safety data isn’t too shabby either: it’s probably not harmful and possibly is even beneficial. (I’m talking about oral consumption — no coffee enemas. Please.) In comparison, energy drinks are a bewildering category of products with an array of ingredients including caffeine, amino acids, vitamins, and other “natural” substances and assorted “nutraceuticals,” usually in a sugar-laden vehicle (though sugar-free versions exist). Given many products contain chemicals with pharmacologic effects, understanding the risks, signs of adverse events, and potential implications on drug therapy, are important.

So are energy drinks just candied caffeine delivery systems? Or are these syrupy supplements skirting drug regulations?

The Message

The ads are seductive. Who doesn’t want more energy? Who doesn’t want their mind and body “vitalized?” And don’t we have time-starved lifestyles? Initially envisioned for athletes, energy drinks are now marketed mainly towards teens and young adults, where uptake has been dramatic. Cross-promotion with extreme sporting events, and creating names like “Full Throttle,” “Rockstar,” and even  “Cocaine” burnish the “extreme” image. The market is now segmented further with products targeted at women, vegetarians, diabetics, celiacs, and more. However you identify yourself, there’s probably an energy drink developed with you in mind. Read more »

*This blog post was originally published at Science-Based Medicine*

Prenatal Vitamins: Are They Necessary, Sufficient, Safe?

What is in a prenatal vitamin? Why do most doctors recommend them? Is there any evidence taking them is worthwhile? I decided recently that I would read through the ingredients of these vitamins, often touted as “essential vitamins and nutrients, crucial for the healthy development of your baby.” Hmmm. Does that mean eating traces of polyvinyl alcohol every day is beneficial?

The fine print ingredients of such brands as “One A Day”, “Centrum Materna”, “Rite Aid” and even the prescription only “Prenate Elite” are a confusing mess of milligrams, international units, RDA’s, and chemicals. As the makers of Centrum explain, “It is very challenging to formulate vitamins and minerals without the use of non-medicinal ingredients which serve to keep the product stable and to prevent the various ingredients from interacting.” They also find fault in the limited number of suppliers of the active ingredients in prenatal vitamins, and therefore claim substances like gelatin are difficult to avoid.

Let’s take a tour of the prenatal vitamin ingredient zoo. Read more »

*This blog post was originally published at The Examining Room of Dr. Charles*

Nutritional Supplements: Do They Really Help Prevent Disease?

(Guest post submitted by MD Anderson Cancer Center)

Aisles in grocery stores and pharmacies are stacked with vitamins, minerals, herbs or other plants that you take in pill, capsule, tablet or liquid form. And, many of us buy these supplements and take them regularly, hoping to lower our chances of getting cancer and other diseases.

But do supplements really work wonders? Should you take them to help prevent cancer? Our experts say beware.

“Don’t be fooled by the label on the bottle,” says Sally Scroggs, health education manager at MD Anderson’s Cancer Prevention Center. “Researchers are still unsure about whether or not supplements actually prevent cancer.” Some studies have suggested that supplements may actually increase cancer risk by tilting the balance of nutrients in the body. Read more »

*This blog post was originally published at Health in 30*

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