The ink had barely dried on our last issue (#64) when one of our unfortunate predictions apparently came true. We received calls from several long-established suppliers of saw palmetto (SP) concerned that the market was being inundated with cheap “SP” oil from Asia. One analysis from a leading supplier suggests that whatever is being offered is palm oil, or some type of fatty oil mixed with palm oil.
In this column we discussed that recent hurricanes had adversely affected the SP crop in Florida and prices had already tripled. Such conditions are ripe grounds for cheap imitations and that seems to be what’s happening. What’s really weird is that SP does not grow in Asia, so there’s no way for Asian extractors to make SP extract unless they had previously purchased large quantities of SP berries from Florida last year or previously, an unlikely scenario. The only place in the world where SP can be harvested is the Southeastern United States. Notice to manufacturers of herbs and dietary supplements: Beware of cheap SP oil being offered from Asia. It’s probably not what it claims to be, and if you try to pass it off on the market, the increased vigilance in many sectors of today’s market suggests that you’re very likely to get caught!
The big news during the past quarter is that in November FDA issued some new guidance documents for the further regulation of dietary supplements—ten years after the passage of DSHEA in October 1994. Such increased regulation is a welcome sign, long overdue, and further evidence that FDA has not fully enforced DSHEA. We have previously stated, as have many others, that what’s needed to remedy the ills and abuses in the dietary supplement industry is full enforcement of existing laws. FDA’s recent publication of new regulatory guidance supports this position. If there are further problems that need to be remedied, then new legislation can be considered.
In December President Bush nominated former Utah governor and EPA Director Mike Leavitt to succeed Tommy Thompson as Secretary of Health and Human Services. Understandably, the herb and dietary supplement manufacturers in Utah are almost dancing in the streets. Leavitt comes from a state with a strong concentration of dietary supplement manufacturers, and he reportedly likes supplements and understands many of the industry’s issues. Having already been through the confirmation process for EPA Director, predictably, he’ll sail through Senate confirmation hearings, particularly with a strong ally in Senator Orrin Hatch, and will probably be instrumental in choosing a new Commissioner for FDA.
In December JAMA published an article showing that 14 (20 percent) of the 70 Ayurvedic herb products purchased from ethnic Indian stores in the Boston area contained excessively high levels of heavy metals (arsenic, lead, mercury). Although this is not defensible, we pointed out in interviews with media, including a short segment on CNN and in the Los Angeles Times, that the offending products were not typical of Ayurvedic herbal preparations sold in natural food stores; they were imported directly from India and circumvented the normal distribution systems for most herbal products. These products were not dietary supplements; they were adulterated and misbranded drugs and are illegal under current federal regulations. Interestingly, another analysis published in November in another journal found no excessive levels of metals in eight different herbs from seven U.S. manufacturers.
There was some good news in the media these past few months. On November 5, ABC News primetime news magazine 20/20 focused on herbs that can improve sexual performance. The segment was part of a larger theme of the show, exposing myths about sex. ABC’s resident physician Dr. Timothy Johnson interviewed herbal author Chris Kilham about his new book Hot Plants and the eponymous line of products from Enzymatic Therapy. The entire segment’s message was that herbs can and do have properties that can be useful in promoting sexual activity. (We were interviewed by phone three times to provide background information for the segment.) A few weeks earlier on “Flipside” on CNNfn, Chris responded to a question regarding the efficacy of the herbs with what may become one of the classic lines of all time: “There’s no such thing as a placebo erection.”
Even though critics have dismissed herbs’ “aphrodisiac” effects, there is increasing scientific evidence supporting the use of botanical preparations to enhance sexual performance. A recent clinical trial on Korean red ginseng demonstrated its nitric oxide-producing effect and efficacy in erectile dysfunction. Several clinical trials on ginkgo leaf standardized extract showed positive results in ameliorating sexual dysfunction caused by some SSRI antidepressant drugs in men and women.
On Sunday, November 21, the CBS news program 60 Minutes aired a segment on hoodia (Hoodia gordonii), the increasingly popular succulent plant in the milkweed family (Asclepiadaceae ) from Namibia in southwestern Africa, now being touted for its ability to suppress appetite. Hoodia was in the news a few years ago, apparently prematurely, when the pharmaceutical giant Pfizer was planning to introduce a new diet drug made from the plant. Pfizer has abandoned its research into hoodia but the ensuing publicity, and now the 60 Minutes coverage, has caused a surge in interest in this new botanical, which to our knowledge, has never been sold previously in the United States. As with any new herb experiencing rapid market demand, we urge manufacturers to ensure that they are obtaining properly identified material and that it is being sustainably harvested.