It's been an even more interesting week than usual in terms of FDA regulations. This week's roundup includes the FDA possibly saying "adios" to antibacterial soap, a warning about painful, long-lasting erections caused by ADD/ADHD medications, and a last-minute backtracking on food production rules promulgated pursuant to the Food Safety Modernization Act.
One of those three topics sounds far more miserable than the other two, eh?
Antibiotics Attacked, Again
Hand soap, you say? Why yes. The FDA has given manufacturers one year to prove that including the controversial chemical triclosan, which is regulated by the FDA as a pesticide, but is included in soap as an antibacterial agent.
According to The New York Times, the FDA's concerns are that the soap may not actually work (some studies show that it takes hours for triclosan to damage bacteria) and that the chemical may disrupt normal development of the reproductive system and metabolism by throwing off hormone levels, including thyroid levels, and cells ability to respond to estrogen and testosterone (the effect has been seen in studies on animals).
What's covered by the proposed rule? Antimicrobial soaps for consumers, but not for medical professionals, and not hand sanitizers (yet).
Stop Taking This Medication if You Have an Erection Lasting Longer Than Four Hours
We've all heard the disclaimers on the plethora of erectile dysfunction drugs that pepper late night television, but the FDA is now warning that the painful side effect of priapism, a long-lasting and painful erection that often has to be drained medically and can cause permanent damage, could result from taking ADHD drugs.
The drugs at issue contain methylphenidate, an ingredient found in Ritalin, Concerta, and Strattera, with the latter showing the highest frequency, according to NBC News.
Before you flush your ADHD pills, however, here is a stat to note: there were only 15 known cases tied to methylphenidate between 1997 and 2012, and there seems to be a link between starting, stopping, increasing, or otherwise changing dosage.
Modernization Can Wait
Fresh off the press, the FDA announced earlier today that they will delay the enactment of food safety regulations, proposed in January, that would've required farmers to take precautions against contamination, such as making sure workers' hands are washed, irrigation water is clean, and that animals are kept out of crop fields.
The FDA submitted the proposals to notice-and-comment procedures, and well, they were noticed and commented upon. Farmers, far and wide, criticized the proposals, and in a blog post this morning, FDA Deputy Commissioner for Foods and Veterinary Medicine Michael R. Taylor stated that revised language will be published in the Federal Register for public comment by early summer.
What are your thoughts about the last-minute backtracking on food safety. How about priapism, or the war on antibiotics? Join the discussion on Facebook at FindLaw for Legal Professionals.
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- This Week in FDA Regulations: 40 States Ask for E-Cig Rules (FindLaw's In House Blog)
- Corporate Counsel Center (FindLaw)