Tag Archives: food and drug administration

GAO: FDA designation doesn’t ensure safety

Ammonium Hydroxide and Phosphoric Acid, both GRAS. Photo by Benny BNut via Flickr.

On his blog Cold Truth (and on AOL News), Andrew Schneider brought our attention to the GAO’s recent investigation into the well-known FDA loophole created by the “generally regarded as safe” or GRAS designation.

The GRAS designation is meant to spare manufacturers lengthy and expensive testing that might otherwise slow the flow of new products to market. It’s conferred, Schneider writes, as long as a “scientific panel selected by the manufacturer can rule that no harm will result from the intended use of an additive.”

Schneider’s version of the highlights of the GAO report:

  • The FDA generally doesn’t know about most of these determinations of “generally regarded as safe,” or GRAS, because companies are not required to inform the agency.
  • The FDA has not taken steps that could help ensure the safety of additives listed as GRAS.
  • Food products may contain numerous ingredients, including GRAS substances, making it difficult, if not impossible, for public health authorities to attribute a food safety problem to a specific GRAS additive.
  • The FDA does not systematically reconsider the safety of GRAS substances as new information or new methods for evaluating safety become available.

The GAO said nanomaterials and imported additives were of particular concern.

(Hat tip to OMB Watch in general and Matthew Madia in particular)

Propofol abuse a concern in medical profession

Alicia Mundy of The Wall Street Journal reports that abuse of the common anesthetic propofol has become a problem the medical profession, where the drug is plentiful and easy to access. The powerful, fast-acting drug enters the bloodstream quickly and makes the user unconscious.

Mundy does note that “The number of people with a propofol problem is small, and there is little data tracking addictions or death.”

The FDA is considering whether to classify propofol as a controlled substance, which professionals say might be problematic because the sedative, which is suspected to have contributed to Michael Jackson’s death, needs to be readily available during emergencies. If it were to become a controlled substance, hospitals would have to “track inventory, account for all vials, list users, and lock it up with narcotics.”

Mundy cites another concern: “Tighter regulation might impede doctors and nurses from seeking help for addiction, because abusing a DEA-controlled drug is more likely to cost them their licenses and lead to criminal charges.”

Hensley: New FDA chief looks to be tough

According to NPR Health Blog’s Scott Hensley, newly confirmed FDA Commissioner Margaret Hamburg sounds like she means business.hamburg-speech

Hamburg vowed to speed things up around FDA headquarters, calling the agency’s processing times for some routine tasks “unacceptable.” She also proposed a new system of publishing “close-out letters” on the FDA Web site when companies resolve a problem about which they had been formally warned by the FDA, presumably in the hopes that violators with clean up their act faster with the added motivation of a publicized clean bill of health.

AHCJ speaker writes about physiology of eating

The New York Times‘s Tara Parker-Pope reviewed former FDA chief Dr. David Kessler’s new book, The End of Overeating: Taking Control of the Insatiable American Appetite. In it, Kessler seems to paint Americans as victims of a carefully calibrated gustatory assault, explaining that the food industry has perfected the art of creating food that “taps into our brain circuitry and stimulates our desire for more.” Though he did not write a diet book, Parker-Pope says, Kessler does try to help folks enter “food rehab,” where they can use their new awareness of food science to “take back control of our eating habits.”

Kessler will be a spotlight speaker at AHCJ’s Aging in the 21st Century Workshop, set for Oct. 16 and 17 in Miami. Tapping into the expertise and understanding of human psychology and physiology he showed in his book, Kessler will discuss nutrition and aging at the workshop.

Wrestling with the FDA recall e-mail avalanche

NPR’s April Fulton recently blogged about a phenomenon familiar to anyone with a subscription to the FDA’s recall e-mail list, or their RSS feed, or their Twitter account: a late rush of random recall messages that would require a prohibitive amount of time to sort and research. fda-recallsFor example, in a two-minute span on June 15, @FDArecalls on Twitter buzzed with messages about multivitamin labels, fish, organic chocolate peanuts, white peppers and soy sprouts. Fulton also notes that many of the notices come out late in the day.

She proposes some sort of flagging or rating system to make it easier to figure out which stories are big deals and which aren’t. She may be on to something. The FDA could make these releases more accessible and useful for journalists and consumers. At the very least, it should be possible to explain the location and magnitude of the public health danger in a way that could be understood at a glance.

What other tips or tricks help you figure out which recalls are relevant to your readers? Do you have suggestions as to how the FDA could makes its releases more accessible or useful? Let us know.