The Food and Drug Administration decided Monday that it will put some new barriers to protect the American people from homeopathic drugs. Some of them are manufactured with dangerous ingredients that can harm the health of the consumers, thus worrying officials who want the products go under stricter enforcement stances.
This kind of alternative and controversial medicine was created in the eighteen century on the idea that small amounts of disease symptoms could cure those same symptoms. However, although scientists have performed further studies on the drugs, they have not proven anything or informed that these claimed-benefits are entirely accurate. In fact, some of them have shown that the products don’t work at all and that they can even negatively affect people.
The U.S. law forces homeopathic products to go under the same approval rules as the other common drugs. However, since the FDA adopted a policy in 1988, it has turned an eye blind and used “enforcement discretions” to let the medicine be manufactured without any further walls.
Since that year, the market has grown into a $3 billion industry, FDA officials agreed.
Not blind-eyed anymore
Just like dietary supplements, the FDA does not review the products before they are marketed. But unlike these supplements, homeopathic products are not made specifically to treat diseases.
The new laws will toughen the process for a lot of homeopathic products, especially those doses made for children and the elders, the ones administrated in vaccines, and those destined to treat the hardest and most delicate illnesses – like cancer and heart disease, or alcohol and opioid addictions.
Despite the proposal that seeks to regulate homeopathic products, tens of low-risk drugs will stay in the market, while others will not be insisted on going through the standard drug-approval process because the agency considers it impractical.
Also, Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said in a statement that these new rules would establish how drugs are going to be considered of high or low risk.
“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 Commissioner Dr. Scott Gottlieb said in a statement.
For the good of the people
These newly enforced laws, detailed in a draft guidance that the public will be able to see in about 90 days, come more than a year after health officials linked the deaths of ten children and other 400 injuries to homeopathic teething tablets and gels – marketed by Hyland’s Homeopathic.
According to a spokesperson, FDA experts by then were able to perform an analysis that lighted the causes of the deaths. It said that the drugs contained “elevated and inconsistent levels” of a toxic substance named “belladonna.”
Also called nightshade, belladonna is a poisonous herb that has been used in homeopathic drugs.
In 2009, the FDA demanded Zicam to stop producing a drug whose principal component was zinc gluconate. This was because 100 people reported having lost their sense of smell after consuming the drug.
On one side of the coin, based in Mount Laurel, N.J., the National Center for Homeopathy is not happy with the FDA’s decision. This organization wrote on its page that this kind of medicine is “a safe, gentle, and natural system of healing” that works with the human body to “relieve symptoms, restore itself” and improve the overall health.
On the other side, people who consume the homeopathic drugs believe that these enforcements might be great for the community. In the end, they only seek to secure the products and avoid tragical events like the one that occurred in April 2016.
The lack of evidence makes it a “placebo”
A biomedical engineer at Johns Hopkins University called Steven Salzberg has lately criticized the Homeopathy industry and the lack of actions from the FDA. According to him, and reported by the Washington Post, it’s “terrific” that the health agency is showing itself harder than before. However, he adverted that he expects the manufacturers to “hit back hard with lots of spurious claims in an effort to confuse consumers and to protect their profits.”
Salzberg also said that the packaging of the products always assured that homeopathy could cure “all sort of conditions” – like pain, colds, asthma, indigestion, arthritis, and more. However, there is no evidence supporting this fact. According to him, this medicine is “silly from a scientific point of view,” he believes it’s more a “religious belief than a scientific belief.”
Similar to this announcement, Britain’s National Health System informed in July that it would forbid doctors from prescribing homeopathic drugs. According to the system’s chief executive, Simon Stevens, this medicine is the “best placebo and a misuse of scarce NHS funds.”
Source: Food and Drug Administration