The feds have told a company associated with alternative health guru Dr. Andrew Weil that it has crossed the line by selling an unapproved product for warding off the swine flu.
The FDA questions the evidence behind the herbal remedy astragalus as a cure-all for H1N1.
In a stern warning letter, the Food and Drug Administration and Federal Trade Commission told Weil Lifestyle LLC to stop marketing a dietary supplement called "Immune Support Formula" as a product that could "diagnose, mitigate, prevent, treat or cure the H1N1 Flu Virus in people."
The regulators pointed to a bunch of health claims on the Web they say are unsupported. Take a look, they said, at a page on the site Dr.Weil.com titled, "The Swine Flu- H1N1," and subtitled, "Swine Flu and You." The original page appears to have been taken down, but you can see an screengrab of the pagehere.
Our email and calls to Weil Lifestyle LLC for comment weren't returned immediately.
What bugged the regulators? For starters, the following advice attributed to Dr. Weil:
"[D]uring the flu season, I suggest taking a daily antioxidant, multivitamin-mineral supplement, as well as astragalus, a well-known immune-boosting herb that can help ward off colds and flu. You might also consider. .. the Weil Immune Support Formula[,] which contains both astragalus and immune-supportive polypore mushrooms ...."
The regulators go on to call out several other statements on the Web site about studies and scientific evidence to back the antiviral and immune-boosting power of the herb astragalus, an ingredient in Immune Support Formula.
The NIH's National Center for Complementary and Alternative Medicine says, "The evidence for using astragalus for any health condition is limited." Data from small and preliminary studies suggest the herb may help the immune system fight infections, the NCCAM says, and researchers funded by the center are studying astragalus's effects on the immune system.
On "Larry King Live" last month, Weil recommended some "interesting strategies" to combat swine flu, including taking capsules of astragalus, which he called "perfectly safe."
King quipped that for a Harvard-educated doctor, Weil has some ideas that sound pretty "far-out." Weil responded, "Well, I don't think they should anymore." The FDA may have the last word on that.
Update: Weil issued a statement saying, "The content that was called into question in the warning was primarily educational, including appropriate strategies to avoid getting the flu this season." Nevertheless, Weil added, "I directed the website team to remove the FDA/FTC-referenced content for review, and they have done so."