Tag Archives: FDA

Former FDA adviser wants LASIK eye surgery banned | BGR

LASIK is one of the most popular kinds of eye procedures around. Once prohibitively expensive, laser eye surgery is now cheaper than ever, and patients often experience very little downtime afterward. Lots and lots of people love their results, but that doesn’t mean there aren’t complications, sometimes severe complications, in certain cases.

Now, a former adviser who worked with the Food and Drug Administration and voted to approve LASIK as a medical procedure, says that the FDA is ignoring data that suggests LASIK should be banned. As CBS News reports, Morris Waxler has regrets about his prior approval of LASIK, and wants the medical community to reevaluate the risks.

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The FDA Is Investigating a Possible Link Between E-cigarettes and Seizures | Live Science

The U.S. Food and Drug Administration (FDA) is investigating a possible link between e-cigarette use and seizures, the agency announced today (April 3).

The FDA said that, between 2010 and 2019, there were 35 reported cases of people who had seizures shortly after they used e-cigarettes. Most of these reports involved teenagers or young adults.

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What Makes the Newly Approved Drug for Depression So Different? | Live Science

On Tuesday (March 5), the U.S. Food and Drug Administration (FDA) approved a ketamine-like nasal spray for patients with depression who haven’t responded to other treatments.

But what makes this newly approved treatment so different?

The drug, called Spravato and made by Janssen Pharmaceuticals, contains the active ingredient esketamine. This substance has the same molecular formula as ketamine but a different chemical structure. (In other words, it contains the same type and number of elements but in a different configuration.) Ketamine is typically used as an anesthetic, but it’s also been used as an illicit party drug.

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Whole Foods gets warning letter from FDA | Money CNN

When it rains, it pours for Whole Foods. Literally, it seems.

The Food and Drug Administration sent a warning letter to Whole Foods co-CEOs John Mackey and Walter Robb about what the FDA called “serious violations” it found after inspecting a Whole Foods food preparation facility in Everett, MA, in February.

The FDA said in the letter — dated June 8 — that it found various items, including pesto pasta, mushroom quesadillas, egg salad and couscous, were in areas where “condensate” was leaking from ceiling joints, a doorway and condenser fan.

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US announces ban on e-cigarettes for under 18s | BBC News

The US government has unveiled new federal rules that include a ban on the sale of e-cigarettes to people aged under 18.

The Food and Drug Administration (FDA) will also require manufacturers to submit products to the agency for review.

Cigars, pipe tobacco and hookah tobacco are also subject to the new rules.

On Wednesday, California introduced new anti-smoking legislation that also regulates e-cigarettes.

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The Popular Over-The-Counter Cold Medicine That Science Says Doesn’t Work | Forbes

The market for over-the-counter cold medicines is worth $8 billion annually, with a hefty portion of that amount spent on drugs marketed as decongestants. But according to new research, the cash many of us will spend on non-prescription decongestants this cold and flu season won’t help us breathe any easier.

According to University of Florida researchers, the oral decongestant phenylephrine simply doesn’t work at the FDA-approved amount found in popular non-prescription brands, and it may not even work at much higher doses. Their conclusions were presented in an editorial in The Journal of Allergy and Clinical Immunology: In Practice, referencing a study in the same edition of the journal conducted by researchers from the Allergy & Asthma Medical Group & Research Center in San Diego.

The study of 539 adults lasted one week and failed to find a dose of phenylephrine within the 10 mg to 40 mg range that was more effective than a placebo in relieving nasal congestion. The approved Food and Drug Administration (FDA) dose is 10 mg every four hours for “temporary relief of nasal congestion.”

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Hampton Creek Throws Eggs at the FDA | Bloomberg Business

iamkfhxw2rjmAsk U.S. food regulators, and they’ll tell you that mayonnaise has to contain eggs, as it has for the past two centuries. But Josh Tetrick, the Silicon Valley entrepreneur hellbent on disrupting a host of food staples with his plant-based substitutes, gives a far different response: Who cares? “I think it is stupid we can’t call our product mayonnaise,” Tetrick says of his two-year-old Just Mayo eggless spread. “I think it’s ridiculous. We’re definitely not changing the name.”

That defiant stance seems to put Tetrick’s company, Hampton Creek, on a collision course with the Food and Drug Administration. The agency on Aug. 12 issued a warning letter listing a litany of rules broken by its Just Mayo and Just Mayo Sriracha products, including the use of “Mayo” in the name and the image of an egg on the label that may imply it meets the agency’s standard definition for mayonnaise—eggs and all. “This is one of the most blatant violations of the standard-of-identity rules that I’ve seen in a long time,” says Elizabeth Campbell, a former acting head of the FDA’s office of food labeling, who now works at EAS Consulting Group.

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5 Percent of “Gluten-Free” Foods Aren’t. New FDA Rules Start Aug. 5 | Businessweek

At last count, 28 percent of adults said they were gluten-free, or something close to it; the U.S. market for gluten-free foods has grown to more than $4 billion. And yet, as anyone who’s ever wondered whether there’s really gluten in oats can tell you, there hasn’t been an official definition of what, exactly, qualifies a food as gluten-free. Now there is one, courtesy of the Food and Drug Administration.

Starting on Aug. 5, packaged foods will be officially considered gluten-free if they contain fewer than 20 parts of the protein per million per kilogram, an amount that even people with celiac disease can tolerate—and the smallest quantity that can be reliably measured. With all the hype and its inevitable debunking, naturally I was suspicious of some gluten-free claims. But the FDA says 95 percent of food labeled gluten-free meets the criteria.

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Herbal supplements: What to know before you buy | MayoClinic.com

Echinacea to prevent colds. Ginkgo to improve memory. Flaxseed to lower cholesterol. The list of herbal remedies goes on and on.

Herbal supplements, sometimes called botanicals, aren’t new. Plants have been used for medicinal purposes for thousands of years. However, herbal supplements haven’t been subjected to the same scientific scrutiny and aren’t as strictly regulated as medications.

For example, makers of herbal supplements don’t have to get approval from the Food and Drug Administration FDA before putting their products on the market.Yet some herbal supplements — including products labeled as \”natural\” — have drug-like effects that can be dangerous. So its important to do your homework and investigate potential benefits and side effects of herbal supplements before you buy. And be sure to talk with your doctor, especially if you take medications, have chronic health problems, or are pregnant or breast-feeding.

Are herbal supplements safe?

Herbal supplements are regulated by the FDA, but not as drugs or as foods. They fall under a category called dietary supplements. The rules for dietary supplements are as follows:

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