The FDA may take a more hands-on approach to regulating homeopathic medicine
It does not go through the same approval process as over-the-counter drugs
Some studies suggest homeopathic medicine is no more effective than placebos
By some estimates, about a third of Americans use some form of alternative medicine, including homeopathic remedies because they find Western medicine inadequate.
Creams such as Arnicare for pain relief or liquids such as Sidda Flower Essences for male virility are part of a $2.9 billion business that has seen “explosive growth,” according to the FDA. These drugs do not go through the same level of scrutiny as over-the-counter and prescription drugs.
But now your over-the-counter homeopathic remedies might soon face stricter scrutiny from the federal government.
Products such as the homeopathic cold remedies Coldese and Zicam, among others, came under fire Monday from experts who testified at a Food and Drug Administration hearing Monday.
The two-day “listening session,” as the FDA calls it, is an opportunity for experts and members of the public to help the FDA decide how it should regulate these products. Critics say the agency is not doing enough.
An analysis of hundreds of published studies from the National Health and Medical Research Council in Australia found that homeopathic medicine was no more effective than a placebo. There is no evidence that they actually work, the council claimed, and yet it is a multibillion dollar business.
Homeopathy is a medical philosophy that essentially believes your body is the best weapon to fight disease. Homeopathic medicine is based on the idea that “like cures like,” meaning if something causes a symptom in your body, if you take a diluted form, it will boost your body’s ability to fight it. Typically these remedies include a plant or a mineral in a tiny amount.
People who represent the industry, such as Mark Land, a member of the American Association of Homeopathic Pharmacists, argue that the current FDA system is a good one and that the products available today are of high quality and label standards are enough.
Critics argued otherwise.
Dr. Adriane Fugh-Berman testified that most people don’t entirely know what homeopathy is and “may assume that these products are dietary supplements or are conventional drugs” since they are often sold on the same shelves as traditional drugs.
This practice is “innately misleading,” said Fugh-Berman, an associate professor in the department of pharmacology and physiology at Georgetown. Most consumers, she said, don’t know that the FDA doesn’t “routinely review these products for identity, purity, potency, quality or stability prior to marketing.”
While many people believe the drugs are safe in large part because they are highly diluted, products such as Cold-Eeze, if taken according to the recommendations on the label, would be 10 times the recommended dietary allowance (RDA) of zinc for adult females and eight times the recommendation for males, according to Fugh-Berman.
Too much zinc can have toxic effects. More than 130 people using another homeopathic medicine with zinc, Zicam, reported to the FDA that they lost their sense of smell. The FDA issued a warning to consumers about it in 2009.
There is a misconception that all homeopathic products are “natural” according to the FDA “and therefore safe. Unfortunately, FDA has become aware of significant safety issues associated with homeopathic products in recent years,” according to an email from the agency.
In 2014, the FDA warned consumers about Pleo Homeopathic drug products having penicillin or derivatives of penicillin.
Another expert asking for stricter standards with homeopathic medicine, Janine Jagger with the Familial Mediterranean Fever Foundation, said that there should be stricter label standards that better explained what was actually in the homeopathic product. She believed there was a “deceptive illusion of treatment” when people chose these homeopathic options over pharmaceuticals that have been proven to work.
A mother and editor of an alternative medicine magazine and website, Peggy O’Mara, testified that homeopathic medicine has helped her family over the years.
As a writer and editor of health publications, she said she has seen a growing interest in this kind of medicine, and she believes it is is well-placed. She believes people have more trust that consumers do their research before purchasing the product, as she does.
She wishes doctors were better versed in this kind of medicine and believes others want “safe, effective and easily accessible” products that are “nontoxic” alternatives to help people feel better.
The public hearing will continue Tuesday. The FDA could make decisions about these labeling and regulation standards some time this year.