FDA Call for Public Comments on Revised Draft Guidance for FDA Staff and Industry Entitled "Drug Products Labeled as Homeopathic"
The following is an excerpt of
Cause & Effect No. 142, November 6, 2019. (
Cause & Effect is the biweekly newsletter of the Center for Inquiry community.)
Call to Experts: Tell the FDA to Get Tougher on Homeopathy
The Food and Drug Administration (FDA) is calling for public comments by January 23, 2020 on its final version of new enforcement guidance for homeopathic “drug” manufacturers, replacing Compliance Policy Guidance (CPG) 400.400, which the agency last updated in March 1995. This new guidance espouses a “risk-based approach” to regulatory enforcement, which, while sounding sensible, comes at a time when we are seeing an across-the-board decline in FDA enforcement actions.
Homeopathic manufacturers may well interpret the “risk-based approach” as carte blanche to sell any product and make any health claim as long as they avoid only the most severe violations, such as claiming to cure terminal diseases or deliberately selling products with lethal quantities of toxic (i.e., “active”) ingredients. (And of course, homeopathy is premised on the dilution of said ingredients into virtual non-existence.)
The new guidance also completely omits the requirement for manufacturers to translate ingredient names from Latin to English. The previous guidance required manufacturers to do so no later than June 11, 1990, and went almost entirely ignored.
Homeopathy does not and
cannot work, and the FDA should be placing
more scrutiny on these products, not less. This is an opportunity to make your voice heard!
If you are a scientist, doctor, health care professional, or if you possess other relevant expertise, we highly encourage you to submit a public comment to the FDA.
We would also love to hear about your comment. Please consider sending us a brief email at
opp@centerforinquiry.org to let us know that you chimed in with the FDA.
Torn From Today's Headlines
By Scott Snell
The National Archives Commemorates Project Blue Book
On November 20, the National Archives issued a press release about a new display in the East Rotunda Gallery of its museum in Washington: "To mark the 50th anniversary of the end of Project Blue Book, the National Archives will display records from the Air Force's unidentified flying objects (UFOs) investigations. The documents display opens on December 5, 2019, and runs through January 8, 2020."
See also:
DCist, the Washington news blog operated by WAMU, the NPR station at American University, took the opportunity to write about the new exhibit and the radar UFOs reported over the Washington area in the summer of 1952:
One would hope that an NPR station-operated news blog would have high standards for accuracy, but the article falls short in a few places. Describing the 1952 radar incidents as occurring "...just five years after the now-legendary incident in Roswell, New Mexico," readers might assume that the Roswell incident was always a famous case, though actually it quickly fell into obscurity and was ignored by UFOlogists from 1947 until 1980.
The article also distorts what the CIA did after the radar incidents: "A few months [later, the CIA] was ready to explain what had happened. In January 1953, the agency sponsored a panel to announce their findings. The official explanation? Temperature inversions..."
The CIA did convene a panel of scientists (the "Robertson Panel") to review, not investigate, a number of UFO cases, including the Washington radar case. But the panel and its work were classified...no announcement/"official explanation" was issued.
Not the CIA, but instead the CAA (Civil Aeronautics Administration, forerunner of today's Federal Aviation Administration) investigated the Washington radar case. Its report supported the temperature-inversion explanation offered by the Air Force soon after the incidents.
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Nick Little is Vice President, General Counsel, and Legal Director of the Center for Inquiry. As CFI's attorney, he supervises the Center's litigation, both in the area of separation of church and state and the protection of the rights of non-believers, where he has brought multiple suits to require states to permit secular wedding celebrants, and in the area of skepticism, where he has filed CFI's groundbreaking consumer protection suit against CVS stores for their deceptive marketing of homeopathy. Educated at Oxford University, the University of Warwick, and Vanderbilt University Law School, Nick seeks to keep CFI involved in cutting edge litigation to further its mission of a secular society based on reason, science, and humanist values. 