Dangerous ‘all natural’ supplements 9/12
(This article is adapted from the September 2012 Consumer Reports magazine.)
More than half of American adults take vitamins, minerals, herbs, or other nutritional supplements. Many of those products are a waste of money, based on the evidence, and some are potentially harmful. Don’t assume they’re safe because they’re “all natural.” They may be neither.
Based on interviews with experts, published research, and Consumer Reports’ recent analysis of reports of serious adverse events submitted to the Food and Drug Administration, there are several so-called “all natural” pills that could be hazardous. Read and be warned.
‘Natural’ products to avoid
Vitamin pills can be synthetically, and legally, produced in a lab. Synthetic ingredients are even allowed in multivitamins that bear the Department of Agriculture’s “Organic” seal. But when it comes to “botanicals,” the FDA has said that synthetic copies of botanicals don’t qualify as dietary supplement ingredients at all.
“Vitamins can be synthetic because, by definition, a vitamin doesn’t have to come from nature,” says Daniel Fabricant, Ph.D., director of the FDA’s Division of Dietary Supplement Programs. “They just have to perform the biological activity of vitamins,” he added. However, a “botanical” is an ingredient that was alive at some point. In other words, botanicals and their extracts must come from actual living plants, not a test tube.
In April 2012, the agency sent warning letters to 10 manufacturers and distributors of products containing dimethylamylamine (DMAA), often touted as a natural stimulant. It said the ingredient lacked safety evidence and warned that synthetically produced DMAA was not a dietary ingredient at all. (The FDA said it is studying the companies’ responses.)
In June and again in August 2012, the agency warned about hidden drug ingredients that can cause serious and potentially fatal side effects found in Reumofan Plus and Reumofan Plus Premium, products marketed as "natural" dietary supplements for treating arthritis, muscle pain, or other conditions.
Consumers should not buy or start using these products. People who have been taking, or recently stopped taking, Reumofan Plus or Reumofan Plus Premium should immediately consult a health care professional, said the FDA.
Supplements are not risk-free
The FDA suspects most supplement problems never come to its attention, says Fabricant at the agency. But those that do are still useful because they can raise red flags about a developing problem. For instance, last year the agency noted seven reports of serious health problems regarding consumers who took Soladek vitamin solution, marketed by Indo Pharma of the Dominican Republic. When the FDA learned that tested samples contained vitamins A and D at concentrations many times the recommended daily allowances, it issued a consumer warning.
Why not simply order a problem product off the market? Current laws make that so difficult for the FDA that to date it has banned only one ingredient, ephedrine alkaloids. That effort dragged on for a decade, during which ephedra weight-loss products were implicated in thousands of adverse events, including deaths.
To see whether a supplement has been subject to warnings, alerts, or voluntary recalls, type the name of the supplement you’re interested in into the search box at www.fda.gov.
If you suspect you’re having a bad reaction to a supplement, tell your doctor. You can also report your problem to the FDA at 800-332-1088 or www.fda.gov/medwatch.
How to choose supplements
The FDA doesn’t require supplements to go through rigorous testing for safety and efficacy the way that drugs are tested. If you choose to take vitamins, botanicals, or other supplements, look for those with the “USP Verified” mark, which means they meet standards of quality, purity, and potency set by the nonprofit U.S. Pharmacopeia.
Check with your doctor before taking traditional herbs, and make sure you know what they are and where they come from. If your culture’s health practices are important to you, consider seeking out an integrative physician, such as Dr. Tieraona Low Dog, who combines conventional medical care with holistic and traditional methods. Bottom line: don’t assume ‘natural’ means safe, or even natural.
10 surprising dangers of vitamins and supplements. 9/12
Dangerous drugs found in 'natural' products, says FDA. 8/12
FDA recalls RegenArouse herbal pills for containing tadalafil. 2/12
Diet supplement Pycnogenol unproven in review for 7 chronic disorders. 2/12
Is it safe to buy herbs from botanicas? 2/12
Reumofan Products Pose Risk to Consumers. (FDA Consumer Update)