Homeopathic drugs regularly slip through FDA process
PHILADELPHIA, PA — King Bio Inc. issued the second significant voluntary recall since late July of their homeopathic drugs on Wednesday. This time, it recalled 32 children’s medicines due to possible microbial contamination that could cause life-threatening infections. The market for homeopathic drugs has ballooned over the past decade into a $3 billion industry that is exposing more and more people to health risks associated with the spread of untested products.
On July 20, King Bio issued a nationwide recall after a routine Food and Drug Administration (FDA) inspection found dangerous microbial contaminants in three products, including baby teething liquids. These recalls follow a January FDA letter to King Bio warning it that all claims about its products health benefits must be supported by scientific evidence. As a result, the Federal Trade Commission has strongly urged King Bio to review its health-related claims.
Safety concerns over homeopathic drugs extend beyond King Bio as over the past several years, the FDA has issued recalls to several companies for a variety of health products from zinc-containing intranasal medicine to asthma drugs with toxic ingredients.
“This latest recall is another reminder that our lax regulation of homeopathic medicine has put our children and our families at risk. We need better mechanisms for ensuring that these products are adequately tested before they hit our store shelves, instead of after,” said Tano Toussaint, Consumer Watchdog Associate for U.S. PIRG.
Since 1988, the FDA has allowed homeopathy companies to distribute and manufacture products without going through the same approval, branding, and purity tests as other drugs. Scott Gottleib, the commissioner of the FDA, said “products labeled as homeopathic have not been reviewed by the #FDA for safety and effectiveness.” In December of 2017, the FDA strengthened its enforcement of homeopathics, saying it would take a “risk-based approach” to regulation and pull products deemed unsafe off the market, whether they have been approved or not. However, the FDA admits that some homeopathic products may slip through the cracks. Beyond that, the agency lacks a consistent enforcement mechanism for recalling unsafe products.
With its updated policy, the FDA has put King Bio and the homeopathic drug industry under heightened scrutiny. However, given how ubiquitous and dangerous these products can be, the FDA needs to step up and increase enforcement and standards for homeopathic medicines.