FDA, pharmaceuticals - supplements industry

Steve Grube grube at ix.netcom.com
Fri Mar 30 22:54:09 PST 2001


This was published on Dr. Dean Edel's website HealthCentral.com. Sadly he doesn't provide a context for understanding how the biggest corporations and industry groups can work with regulatory bodies in co-oping a burgeoning industry. Also, the international body Codex is being used to set up "international stds" which will ensure soon that you can only obtain vitamin/mineral/herbal supplements from a drug store by prescription. -Steve Grube

Americans favor regulation of dietary supplements

March 28, 2001

NEW YORK (Reuters Health) - As the government gets set to issue new regulations for the dietary supplement industry, survey findings show that most Americans favor tighter quality control of the burgeoning market.

In response to growing concerns over the quality and safety of dietary supplements, which are largely unregulated in the US, the federal Food and Drug Administration (FDA) has developed manufacturing rules for the industry. The regulations have not yet been finalized.

The FDA and supplement manufacturers have been widely criticized for the lack of standards in manufacturing and marketing dietary supplements. But, according to a report in the March 26th issue of the Archives of Internal Medicine, little is known about how Americans view government regulation of popular supplements such as St. John's wort, ginseng and creatine.

Now an analysis of six national surveys on Americans' attitudes about dietary supplements shows that about 80% favor giving the FDA greater authority over manufacturers.

There also seems to be widespread confusion about the government's current role in overseeing the supplement industry, according to researchers led by Dr. Robert J. Blendon of the Harvard School of Public Health in Boston, Massachusetts.

One survey of about 2,000 people revealed that more than one-third believed the government currently regulated supplements and another 12% were unsure.

Since 1994, the year Congress passed the Dietary Supplement Health and Education Act (DSHEA), supplement sales have risen by nearly 80%, the authors note. DSHEA made manufacturers responsible for testing the safety of supplements before marketing them and for ensuring that the product contents match what is on the label. Manufacturers can also make certain claims about a product's health-promoting effects without FDA approval.

While the popularity of various over-the-counter herbs, amino acids and hormones continues, dietary supplements have garnered some bad publicity of late. For instance, independent analyses have revealed that the ingredient labels on many product brands may not match what is inside the container.

The surveys Blendon's team examined showed that half of Americans regularly use some type of supplement, including vitamins and minerals. About 18% regularly use botanicals such as echinacea and ginseng, amino acids such as creatine, or synthetic hormones, which include the purportedly muscle-building androstenedione. And these users believed whole-heartedly in the health benefits of supplements. In one survey, one-third said supplements would help them live longer. Overall, 85% of regular users said dietary supplements promote good health and well-being.

"However," Blendon and his colleagues report, "the growing enthusiasm for dietary supplements does not mean that there is not support for stronger regulation that would require FDA review of the safety of new dietary supplements prior to their sale and that would give the FDA ample authority to remove from the market those products shown to be unsafe."

But, the researchers note, many Americans also seem skeptical about scientists' motivations for scrutinizing supplements. They will likely want "clear evidence" of a safety hazard before favoring the removal of certain supplements from the market, the authors conclude.



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