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Massive Recall of Homeopathic Kids' Products Spotlights Dubious Health Claims

posted by martyb on Monday August 27 2018, @02:50PM   
from the Phineas-Taylor-Barnum's-Progeny dept.

MrPlow writes in with a submission via IRC for SoyCow1984:

When they're not potentially infectious, they have extraordinary health claims.

The maker of wide-ranging "water-based homeopathic medicines" has recalled 32 products marketed to children and infants due to microbial contamination, according to an announcement posted on the Food and Drug Administration's website this week.

The announcement does not provide any specifics about the contamination or potential risks. However, the North Carolina-based manufacturer behind the recall, King Bio, issued a similar announcement back in July. At that time, the company recalled three other products after an FDA inspection found batches contaminated with the bacteria Pseudomonas brenneri, Pseudomonas fluorescens, and Burkholderia multivorans.

Pseudomonas brenneri is a bacterium recently found in natural mineral waters, and its clinical significance is murky. However, Pseudomonas fluorescens is known to be an opportunistic pathogen, causing blood infections, and Burkholderia multivorans can cause infections in people with compromised immune systems and cystic fibrosis. It was also recently found to be a rare but emerging cause of meningitis.

[...] UPDATE 8/24/2018: King Bio updated its website to include a note about the recall. The company wrote that: "Within the past two weeks, microbial contamination was discovered in two children's products, but as an added measure of caution, we chose to recall all the children's products manufactured from August 2015 to August 2018." It added that no injuries or illnesses have been reported to date.

Source: https://arstechnica.com/science/2018/08/massive-recall-of-homeopathic-kids-products-spotlights-dubious-health-claims/

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Original Submission

• Re:This is the proper role of the FDA Re:This is the proper role of the FDA (Score: 0) by Anonymous Coward on Monday August 27 2018, @04:28PM (4 children)

  by Anonymous Coward on Monday August 27 2018, @04:28PM (#726976)

  Fine, use "banned" in your sense (anything the organization is not specifically told to do).

  Then they were originally "banned" from regulating the efficacy of all drugs, whether "homeopathic" or not.

  Parent

• Re:This is the proper role of the FDA Re:This is the proper role of the FDA (Score: 2, Informative) by Anonymous Coward on Monday August 27 2018, @04:59PM (3 children)

  by Anonymous Coward on Monday August 27 2018, @04:59PM (#726993)

  The FDA didn't have the authority to regulate pharmaceuticals at all until 1938, after the elixir sulfanilamide disaster. They didn't even have the authority to insist that pharmaceuticals have proper tests for efficacy and safety before marketing until 1962, after the thalidomide tragedy. And after 1994, they created a new class of substances called "supplements" that have more lax regulation. It's what these homeopathic remedies are under, which is why they don't need to meet the efficacy and safety standards of real drugs and the FDA is basically unable to ban them unless some contamination like this happens.

  Parent

  • Re:This is the proper role of the FDA Re:This is the proper role of the FDA (Score: 0) by Anonymous Coward on Monday August 27 2018, @06:06PM (2 children)

    by Anonymous Coward on Monday August 27 2018, @06:06PM (#727036)

    Yep, the FDA has suffered massive mission creep with simultaneously lack of appropriate funding increases along with people carving out their own political exceptions. It should be reverted back to 1938 or even earlier.

    Parent

    • Re:This is the proper role of the FDA Re:This is the proper role of the FDA (Score: 0) by Anonymous Coward on Tuesday August 28 2018, @02:43AM (1 child)

      by Anonymous Coward on Tuesday August 28 2018, @02:43AM (#727213)

      I'd roll it back to 1962 at most. Probably just before 1994, and that awful DSHEA law which created "dietary supplements". If we go before 1938, we go back to the era of medicine shows with an FDA that had absolutely no power whatsoever to regulate pharmaceuticals.

      Parent

      • Re:This is the proper role of the FDA (Score: 0) by Anonymous Coward on Tuesday August 28 2018, @10:50AM

        by Anonymous Coward on Tuesday August 28 2018, @10:50AM (#727291)

        Before 1938 is before NHST.

        Parent