ICYMI: Dietary Supplement Users - Caveat Emptor

Editor’s note: Here’s an article originally published March 5 on Westport Patch by Star Patcher Roy Fuchs about Florence Ricciuti’s recent talk before the Y’s Men of Westport-Weston about alternative medicine. We’re republishing it here in case you missed it:

By Roy Fuchs (Star Patcher)

“Read the label, know the interactions, tell your physician” was a takeaway from the talk Florence Riccuiti, Ph.D, made to Y’s Men about the pros and cons of alternative medicines last week.

Ricciuti is a geneticist and public health expert who has had a long career managing clinical trials for Bristol-Meyers Squibb.

We all have a pretty good idea what dietary supplements are, many of us use them, but what do we really know about them? Riccuiti filled us in.

Alternative medicines, she said, include natural treatments—“anything that might come from a natural source, vitamins and minerals, probiotics, bacterias found in yogurt;” and manipulative treatments including acupuncture, yoga, meditation, and similar treatments that are often “effective in reducing pain.”

Leaving the manipulative treatments aside, Riccuiti described two types of dietary supplements: Alternative medications, those used in place of a conventional medicine, and complementary, those used along with conventional medications.

Supplements differ substantially from prescription drugs. The FDA regulates prescription drugs, while the $32 billion dietary supplement industry has no similar oversight agency or requirement.

“Prescription drugs must go through pre-clinical trials and testing in humans to show they are safe and effective.” When the trials are completed and drugs go into production, the FDA requires quality control at every step—with out of specification products destroyed immediately.

The FDA also requires that product labels provide consumers all the important information, especially what the drug is meant to do and what its adverse side effects are.

With supplements, “You don’t know what you’re getting - it’s up to the manufacturer to determine quality, safety and effectiveness.” Supplement labels tell users what the ingredients are, and what the product does, but “there can be no claim to diagnose, treat, cure or prevent any disease, nor are there guarantees of safety and effectiveness.”

This places the burden of learning about interactions with prescription drugs on the consumer, and makes it essential that they tell their physician about every supplement they use. Ricciuti noted, for example, that St. John’s Wort, a supplement taken for depression, may interact with warfarin (Coumadin, et al) and with statins (Lipitor, et al). Even supplements such as cinnamon, garlic and even licorice can have interactions with warfarin drugs.

Yet there is a way for supplement producers to give customers some assurance. US Pharmacopeia registers drug ingredients and certifies all dietary supplements whose ingredients meet its standards. This permits the manufacturer to place the USP mark on the product’s label, and tell users the named ingredients are used. But it still does not address the effectiveness and safety issues. And the USP leaves the task of enforcing its standards to the FDA and other government agencies.

One well publicized consequence of this lack of regulation is now being addressed by the New York Attorney General’s office. It recently found that samples of four of five major house branded supplements sold by Wal-Mart, Walgreen’s, GNC and Target largely contained fillers in place of the herbs listed on their labels. All the products were recalled.

How widely used are supplements? Ricciuti cited a National Health Information Survey for which 85,000 people were polled randomly about how they treat various health conditions. One-third said they take complementary medicines, 17 percent take multi-vitamins or multi-minerals.

The failure of the supplement industry to self-police has lead Senators Richard Blumenthal (D-CT) and Dick Durbin (D-IL) to introduce the Dietary Supplement Labeling Act of 2014, which would require registration of products and force manufacturers to follow procedures similar to that used by prescription drug makers. She opined that is a “dead issue even though it concerns safety” in our current congress.

Ricciuti listed a few of websites dispensing information—“sites you can trust.” One is the National Center for Complementary and Integrative Health. Others include the FDA (fda.gov), a site for senior health (nihseniorhealth.gov,), and an NIH site for dietary supplements (myds.nih.gov).

She closed with “Natural does not always mean safe… read the label find out what’s in it; tell your physician if you’re taking a supplement; and take advantage of information on reliable sources.”

Photo by Larry Untermeyer