deaths" over a six-year period. The investigation (including analyses of the products) is still ongoing and the FDA does not know yet if the deaths and illnesses were caused by the products. However a previous FDA investigation in 2010, following adverse effects reported then, found that these same products were improperly diluted and contained "unsafe levels of belladonna, also known as deadly nightshade" and that the reports of serious adverse events in children using this product were "consistent with belladonna toxicity". Instances of arsenic poisoning have occurred after use of arsenic-containing homeopathic preparations. Zicam Cold remedy Nasal Gel, which contains 2X (1:100) zinc gluconate, reportedly caused a small percentage of users to lose their sense of smell; 340 cases were settled out of court in 2006 for . In 2009, the FDA advised consumers to stop using three discontinued cold remedy Zicam products because it could cause permanent damage to users' sense of smell. Zicam was launched without a New Drug Application (NDA) under a provision in the FDA's Compliance Policy Guide called "Conditions under which homeopathic drugs may be marketed" (CPG 7132.15), but the FDA warned Matrixx Initiatives, its manufacturer, via a Warning Letter that this policy does not apply when there is a health risk to consumers. A 2000 review by homeopaths reported that homeopathic preparations are "unlikely to provoke severe adverse reactions". In 2012, a systematic review evaluating evidence of homeopathy's possible adverse effects concluded that "homeopathy has the potential to harm patients and consumers in both direct and indirect ways". One of the reviewers, Edzard Ernst, supplemented the article on his blog, writing: "I have said it often and I say it again: if used as an alternative to an effective cure, even the most 'harmless' treatment can become life-threatening." A 2016 systematic review and meta-analysis found that, in homeopathic clinical trials, adverse effects were reported among the patients who received homeopathy about as often as they were reported among patients who received placebo or conventional medicine. Lack of efficacy The lack of convincing scientific evidence supporting its efficacy and its use of preparations without active ingredients have led to characterizations as pseudoscience and quackery, or, in the words of a 1998 medical review, "placebo therapy at best and quackery at worst". The Russian Academy of Sciences considers homeopathy a "dangerous 'pseudoscience' that does not work", and "urges people to treat homeopathy 'on a par with