By Richard Harkness
The Cincinnati Enquirer

Question: You have pointed out that herbal supplements are loosely regulated, resulting in quality-control problems. Why doesn't the Food and Drug Administration regulate them?

Answer: The short answer is that FDA's hands are tied: it can't regulate dietary supplements in the same way it regulates prescription and over-the-counter drugs.

As herbal and other dietary supplements became more popular and exaggerated claims climbed the scale, there were demands that these products, like drugs, be proven safe and effective. In an effort to sidestep such restrictions, some consumer groups and supplement manufacturers joined hands to lobby for the passage of DSHEA (the Dietary Supplement Health & Education Act). This legislation, passed in 1994, threw a protective umbrella over products containing ingredients such as herbs, vitamins, minerals and amino acids by classifying them as "dietary supplements" instead of drugs.

DSHEA accepted some token regulation, primarily related to product labeling, as a compromise to escape the much stiffer regulations required for drugs.

The offshoot is that supplement manufacturers, unhampered by the burden of proving the safety and efficacy of their products, could channel their resources into marketing and promotion.

That started the boom in these products that continues today.

As to safety and efficacy of dietary supplements, at least there are authoritative books and Web sites that offer such information based on available research, though the amount and quality of evidence is skimpy.

However, there has been little help for the consumer on a pressing problem that presents real health dangers: lack of enforced quality-control standards in the manufacturing of dietary supplements. It's mainly left up to manufacturers to police themselves. Translation: If you think what is printed on product labels must be factual, you may be in for sticker shock in some cases.

As I reported recently, a popular supplement for prostate cancer was taken off the market because it contained the prescription blood thinner warfarin, and a brand of the herb nettle was recalled due to lead contamination. Other examples: One study revealed that 20 percent of ginseng products tested contained no ginseng at all; Oriental herbal remedies used for arthritis were found to be laced with steroid drugs; the heart drug digitalis was detected in samples of raw material labeled "plantain." The list goes on.

Such disclosures tend to give an undeserved black eye to those supplement manufacturers who practice good quality control.

As I said in a recent column, the best solution seems to be independent, third-party content testing and certification of dietary supplements such as that offered by organizations such as USP, NSF, NNFA and ConsumerLab.com.

Most reputable companies favor having their products independently certified. That validates their quality-control efforts and sets them apart from the competition.

Certification is a trend that is gaining momentum. It should help consumers identify trustworthy dietary supplements that contain what the label promises without unsafe contaminants.

E-mail rharkn@aol.com