from the no-choking-hazzard-here,-either dept.
Ars Technica is reporting on a story where the CDC report that a Homeopathic “healing bracelet” caused lead poisoning in a infant girl
[...] during a routine health screening. Healthcare workers found that the baby was anemic and had a blood lead level of 41 micrograms per deciliter (μg/dL). While no level of lead is known to be safe, the CDC recommends health interventions when a child’s blood lead level reaches 5 μg/dL.
[...] The authorities subsequently homed in on the bracelet, a homemade “homeopathic magnetic hematite healing bracelet.” The baby’s parents said they bought it from an artisan at a local fair and gave it to the baby to wear and mouth to ease teething pain. Small spacer beads on the bracelet (shown) tested positive for lead at a level of 17,000 parts-per-million. The Consumer Product Commission in 2010 set the allowable limit of lead in products intended for children at 100 parts-per-million.
The authors of the report—Drs. Patricia Garcia and Jennifer Haile, lead treatment specialists at Connecticut Children’s Medical Center—noted that the bracelet had no warnings or branding. They added that they couldn’t get the fair’s vendor information and were unable to track down the bracelet’s maker.
Also at Live Science
The FDA is proposing a new, risk-based enforcement approach to homeopathic drug products (alternative medicine):
To protect consumers who choose to use homeopathic products, this proposed new approach would update the FDA's existing policy to better address situations where homeopathic treatments are being marketed for serious diseases and/or conditions but where the products have not been shown to offer clinical benefits. It also covers situations where products labeled as homeopathic contain potentially harmful ingredients or do not meet current good manufacturing practices.
Under the law, homeopathic drug products are subject to the same requirements related to approval, adulteration and misbranding as any other drug product. However, prescription and nonprescription drug products labeled as homeopathic have been manufactured and distributed without FDA approval under the agency's enforcement policies since 1988.
"In recent years, we've seen a large uptick in products labeled as homeopathic that are being marketed for a wide array of diseases and conditions, from the common cold to cancer. In many cases, people may be placing their trust and money in therapies that may bring little to no benefit in combating serious ailments, or worse – that may cause significant and even irreparable harm because the products are poorly manufactured, or contain active ingredients that aren't adequately tested or disclosed to patients," said FDA Commissioner Scott Gottlieb, M.D. "Our approach to regulating homeopathic drugs must evolve to reflect the current complexity of the market, by taking a more risk-based approach to enforcement. We respect that some individuals want to use alternative treatments, but the FDA has a responsibility to protect the public from products that may not deliver any benefit and have the potential to cause harm."
FDA draft guidance (8 pages).
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