Posts Tagged ‘FDA’


Wednesday, September 12th, 2018

Apple Watch Series 4

Apple has introduced the Apple Watch Series 4. Fundamentally redesigned and re-engineered with a new edge-to-edge screen (30% larger) and sound (speaker is 50% louder), it purports to help users stay even more active, healthy, and connected than before.  Branding itself as a medical device, the FDA-cleared Series 4 monitors heart rhythm as it takes its user’s electrocardiogram (EKG).  This data can indicate whether one’s heart rhythm shows signs of atrial fibrillation or if sinus rhythms are normal.  The device is also able to recognize a fall and offer Emergency SOS, which calls 911 or notifies emergency contacts.

“The Apple Watch has become an intelligent guardian for your health,” Apple COO Jeff Williams said at Wednesday’s announcement.  “Consumers are now empowered to take more control of their own health information to make better informed decisions about their medical care and healthy living,” said FDA Commissioner Scott Gottlieb in a statement.  The Watch Series 4 is available for order on Friday, starting at $399 (for GPS) or $499 (for GPS + cellular service).


Wednesday, August 29th, 2018

image courtesy of Shutterstock

In March, Los Angeles Superior Court Judge Elihu Berle ruled that coffee sellers in the state of California must label their products with a cancer warning, due to the presence of acrylamide.  Acrylamide, a chemical only linked to cancer in animals when consumed in high doses, can form in many foods during high-temperature cooking, such as frying, roasting, and baking.  In coffee, acrylamide forms during the roasting of coffee beans.  Under Proposition 65, also known as the Safe Drinking Water and Toxic Enforcement Act of 1986, California requires products to contain cancer warnings if they will expose consumers to chemicals which state health authorities have identified as cancer-causing.

However, in a comprehensive report conducted by the World Health Organization’s International Agency for Research on Cancer, current science indicates that consuming coffee poses no significant risk of cancer.  Acrylamide in food forms from sugars and an amino acid that are naturally present in food. It doesn’t come from food packaging or the environment.  Based on this new report, the California agency that administers Proposition 65 has proposed a regulation to exempt coffee from a Proposition 65 cancer warning — and the FDA agrees.



Tuesday, August 28th, 2018

image courtesy of

The U.S. Food and Drug Administration today announced it has warned four more online networks, operating a total of 21 websites, illegally marketing potentially dangerous, unapproved, and misbranded versions of opioid medications, including tramadol. The warning letters issued by the FDA to each of the networks state that they must immediately stop illegally selling these products to American consumers.

“The illegal online sale of opioids represents a serious risk to Americans and is helping to fuel the opioid crisis. Cutting off this flow of illicit internet traffic in opioids is critical, and we’ll continue to pursue all means of enforcement to hinder online drug dealers and curb this dangerous practice,” said FDA Commissioner Scott Gottlieb, M.D. “Today’s effort builds on previous actions against the illegal online sale of opioids, for a total of 13 warning letters to more than 70 websites just this summer. The FDA remains resolute in our promise to continue cracking down on these networks to protect the public health. We have more operations underway, and additional actions planned. We are also working closely with legitimate Internet stakeholders, including leading social media sites, in these public health efforts.” (more…)