Politics and Regulation
Sen. Dick Durbin (D-IL) plans to introduce legislation to regulate dietary supplements more strictly. Seems the Senate has been unable to do much of anything. Maybe they can agree on some supplement bashing? Food and drug attorney Justin Prochnow (Greenberg Traurig, Denver) comments on the issue: Once again, Senator Durbin has taken a run at […]
Another black eye for the so-called “ethical pharmaceutical” business. In what is being called “the biggest research fraud in medical history,” a member of Pfizer’s “speaker bureau” has pled guilty to fabricating dozens of drug studies. Dr. Scott Reuben, working on a $75,000 grant from Pfizer produced a research study on their drug Celebrex. Naturally, […]
Prince Charles says “herbal medicine must be regulated.” As a long time proponent of alternative medicines, we wonder if this is a new position for him, or a response to EU regulation.
Green tea is the fourth most commonly used dietary supplement in the United States. After the publication of adverse event case reports involving green tea products and potential liver toxicity, the US Pharmacopeia reviewed safety information for green tea products. 216 case reports on green tea products were analyzed including 34 reports concerning liver damage. […]
the health minister of the South American nation of Guyana is becoming concerned about the “growing power and influence of alternative medical practitioners” and is seeking to rein in some of the “more exaggerated claims.” The Guyana Association of Alternative Medicine shares some of those concerns, and official medical institutions have they “uneasy coexistence with […]
from the U.S. cGMPs for Dietary Supplements by James Prochnow The CGMPs for dietary supplements do not apply to dietary ingredient manufacturers, labelers, packers and those who hold dietary ingredients unless and only if a dietary ingredient is sold in bulk and then repackaged and, without further processing, is sold as a single component dietary […]
Final Rule on Dietary Supplement cGMP Released from AHPA (June 22, 2007) — The U.S. Food and Drug Administration (FDA) has posted its final rule on current good manufacturing practice (cGMP) for dietary supplements at its website and will soon publish the rule in the Federal Register. The agency has simultaneously posted a related interim […]
Industry experts are proclaiming victory in getting a law passed that requires dietary supplement (and OTC drug) manufacturers to report all serious “adverse events” to their products to the FDA. With the obvious bias in the media against supplements, each reported (but not proven) “reaction” will likely be used to hammer dietary supplements.
The “Organic Consumer’s Association” comes on like a champion of ethics in organics, but really, aren’t these pretty extreme positions? OCA has joined the shrill, pharma-sponsored attacks on dietary supplements.
