FDA to crack down on “potentially harmful, unproven homeopathic drugs”
Most homeopathic drugs will be left alone
Earlier this week, the FDA announced a coming crackdown on “potentially harmful, unproven homeopathic drugs”.
Homeopathic drugs are holistic and said to stimulate the body’s power to heal itself by focusing on the entire picture of health and not only the ailment needing treatment. Some swear by homeopathy, even if there’s little science to back it up.
Unlike agency crackdowns of administrations past, the FDA’s recent announcement aims to protect consumers from snake oil salesman promising untested relief from serious medical issues.
“In recent years, we’ve seen a large uptick in products labeled as homeopathic that are being marketed for a wide array of diseases and conditions, from the common cold to cancer. In many cases, people may be placing their trust and money in therapies that may bring little to no benefit in combating serious ailments, or worse – that may cause significant and even irreparable harm because the products are poorly manufactured, or contain active ingredients that aren’t adequately tested or disclosed to patients,” said FDA Commissioner Scott Gottlieb, M.D. “Our approach to regulating homeopathic drugs must evolve to reflect the current complexity of the market, by taking a more risk-based approach to enforcement. 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.”
Unlike other drug manufacturers, products labeled ‘homeopathic’ “have been manufactured and distributed without FDA approval under the agency’s enforcement policies since 1988,” according to the FDA.
Most homeopathic products will be left alone — those claiming to help with routine health issues like the common cold, acne, allergies, those types of ailments. But products targeting vulnerable populations will be subject to FDA scrutiny:
The FDA’s proposed approach prioritizes enforcement and regulatory actions involving unapproved drug products labeled as homeopathic that have the greatest potential to cause risk to patients. Under this approach, many homeopathic products will likely fall outside the risk-based categories described in the new draft guidance and will remain available to consumers. The FDA intends to focus its enforcement authorities on the following kinds of products:
- products with reported safety concerns;
- products that contain or claim to contain ingredients associated with potentially significant safety concerns;
- products for routes of administration other than oral and topical;
- products intended to be used for the prevention or treatment of serious and/or life-threatening diseases and conditions;
- products for vulnerable populations; and
- products that do not meet standards of quality, strength or purity as required under the law.
Examples of products that may be subject to the enforcement priorities in the draft guidance are infant and children’s products labeled to contain ingredients associated with potentially significant safety concerns, such as belladonna and nux vomica; and products marketed for serious conditions, such as cancer and heart disease.
Homeopathy was a small, niche market for more than 100 years, but in the last decade, the homeopathic drug market has exploded to a nearly $3 billion industry.
“During this time, the FDA has seen a corresponding increase in safety concerns, including serious adverse events, associated with drug products labeled as homeopathic. In addition, the agency has also found an increasing number of poorly manufactured products that contain potentially dangerous amounts of active ingredients that can create additional risks,” says the FDA.
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“Herbal remedies are still drugs. And, drugs all have side effects.” BUT if they’re truly homeopathic then they’ve been diluted to the point where a retail-size bottle might not contain even one molecule of the remedy.
The supplements and homeopathic remedy business is a medicine show; nonetheless, Congress has chosen to give FDA scant if any authority to regulate it.
If FDA wants some sort of “safe and effective” requirement for these products, along with the authority to do something (anything) other than whine if these are not met, then it really needs enabling legislation. Without that, it will surely get its toes stubbed.
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