Last year, Hyland’s Homeopathic and CVS Pharmacy were targeted in lawsuits over a product intended to relieve teething pain in infants and young children. The product, which contained an extract from the belladonna (deadly nightshade) plant, causes seizures, respiratory distress and urinary difficulties; 400 children were affected, 10 of whom died.
This week, the FDA announced that it will be stepping up enforcement efforts against companies that market homeopathic remedies. The focus will be on cases in which such products are promoted as treatments for serious diseases, but have not been scientifically proven to have any benefits, and may even contain potentially toxic ingredients.
Homeopathic medicine was first developed during the late 18th Century by a German physician named Samuel Hahnemann (1755-1841). While considered to be “cutting-edge” medicine in its time, many of its underlying principles have since been disproven by scientific discoveries made over the past 200 years.
Nonetheless, homeopathy continues to have practitioners and adherents. There are a few related reasons for this. First of all, there is decreasing trust in the pharmaceutical industry, which has in recent years come out with numerous products with dangerous and even fatal side effects – and there is a common perception that simply because something is “natural” or “organic,” it is somehow “safe”.
Another reason is Big Pharma’s psychopathic greed. In recent years, pharmaceutical companies have engaged in egregious price gouging, raising the costs of life-saving medications by astronomical amounts. Homeopathic remedies, on the other hand, tend to be inexpensive and do not require a prescription. Over the past ten years, homeopathy has grown into a $3 billion-a-year industry.
What people do not always realize is that pharmaceutical products often contain the same plant extracts as so-called “natural” or homeopathic remedies. The difference is that a “natural” remedy generally uses the whole plant, which contains many different compounds. With a prescription drug, a single compound is isolated and concentrated. Nonetheless, even though such compounds contained in homeopathic remedies are highly diluted, they can still have the same side effects and interactions.
Under current law, homeopathic remedies are treated like dietary supplements in that they do not undergo FDA review for safety and efficacy. However, manufacturers can market them as remedies for specific disorders, provided there is a disclaimer on the label.
In addition to Hyland’s teething product, a number of other homeopathic products have been pulled from the market because of harmful side effects, including three cold remedies from Zicam which contained zinc gluconate and caused 100 people to lose their ability to smell. There are also digestive remedies containing a substance known as nux vomica, which is derived from strychnine, a deadly poison.
In a statement, FDA Commissioner Dr. Scott Gottlieb said, “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.”
Under the new policy, most products determined to be low-risk will remain on the market; however, the FDA will be scrutinizing products claiming to treat serious conditions such as cancer, or are administered in unusual ways, such as being placed in the ear. The FDA is currently accepting comments on its proposal for the next ninety days; consumers can also submit reports at the FDA website.