Drugs and Cosmetics

Proposed FDA Regulation Reopens Courthouse Doors to Consumers After the Mensing Decision

Richard Schulte, Esq. at www.legaldayton.com This week the FDA made game changing moves dealing with American health and drug manufacturer liability. Their hope, is that fair game will be established between brand name and generic manufacturers—and that means equal liability. FDA’s movement for parity stems from the contentious ruling of Pliva v Mensing, 131 2 Ch 2357 (2011). The Mensing ruling was a big win for generic drug makers, who make up about 80% of the pharmaceutical market. It states that generic drug manufacturers cannot be sued for failing to warn consumers of dangerous side effects, as long as their …

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Dietary Supplement Linked to 29 Cases of Liver Damage in Six Months

The dietary supplement OxyELITE Pro has been pulled from shelves nationwide after 29 cases of liver failure. All of the cases occurred within a sixth month period in the state of Hawaii. The pause in distribution comes shortly after the Health Department of Hawaii requested voluntary removal of the supplement and urged Hawaiians to cease using it. Strong evidence linking OxyELITE Pro to the cases of liver damage—including one death last week, the loss of a 48 year-old mother of 7—is difficult to ignore. At least 24 of the 29 patients treated had taken the supplement. No other supplement has …

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New Study Reveals Antipsychotics Linked to Diabetes in Children

Tad Thomas, Esq. A new study suggests that children prescribed antipsychotics are three times more likely to develop type II diabetes than children taking other psychotropic medicines (such as antidepressants or anti-anxiety drugs). It is not the just discovery of the diabetic link that makes this study so significant, but the magnitude of its risk. Doctors acknowledge that side effects of the antipsychotics include weight gain and insulin resistance, but their connection to rapid development of type II diabetes is concerning news. According to CNN Health, doctors usually think of diabetes as a condition developed over the long run, but …

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The “Cosmoceutical” Problem

Elise Sanguinetti, Esq. The FDA is responding to an increase in cosmetics that claim to slow and even reverse the fate of aging. A quick Google will bring up articles about misbranding, exaggerated advertising, and forums about products that don’t really work. All of these issues are true and part of the broader FDA address, but not exactly where the FDA steps in. What the FDA is actually dealing with is line between what is sold as a cosmetic, but claimed as a drug. This mislabeling is what unfairly affects consumers. While neither law nor the FDA recognizes “cosmoceutical” as …

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