30, August 2018
The FDA has warned consumers to stop using human and animal drug products manufactured by Asheville, NC-based King Bio Inc. immediately. This follows the agency’s detection of high levels of microbial contamination at King Bio’s manufacturing facility. King Bio Inc. manufacturers homeopathic products for a number of ailments including colds, chickenpox, learning deficiencies, appetite loss, warts and indigestion, in addition to a variety of pet products.
The FDA’s conviction is that medicines that are manufactured in such conditions could adversely affect the safety of people who take them, especially children, pregnant women, and people with a compromised immune system. When consumers and pets consume these contaminated products, they could become vulnerable to risk of serious infection that could require urgent medical attention. In the case of immunocompromised people, infection caused by contaminated products could even become life-threatening.
The FDA sees its action as part of its effort to crack down on companies that market homeopathic products with unproven and unscientific effectiveness claims for any ailment from colds to cancers. Many homeopathic drugs not only fail to deliver on the claims they make; those that are manufactured in contaminated conditions also end up causing problems to its users, more so children, pregnant women and those with low immunity.
It is to counter these negative fallouts that the FDA has cracked the whip on companies that it has discovered to be involved in these malpractices. On its part, King Bio has agreed to voluntarily recall all of its aqueous-based products for human and animal use as a precautionary measure, even though it is yet to receive a case of any report of illness of injuries resulting from the use of its products.
Homeopathic drugs are derived from plants, animals, minerals, chemicals or human sources. The FDA does not regulate or approve homeopathic drugs, but when it comes to approval, adulteration and misbranding, homeopathic drugs are subject to the same rules that other drugs are. It does not prescribe standards and procedures for such drugs. Most homeopathic manufacturers brand these products as safe alternatives to allopathic drugs and market them offline and online.
Because of the lack of scientific standards into this system of medicine, the FDA started taking a new, more aggressive line on homeopathic drugs. Considering the potential for risk among vulnerable groups that consume these medicines, the FDA proposed a novel, risk-based enforcement plan for homeopathic drugs in its approach towards any drug that is labeled as homeopathic. It updated its policy in December 2017, by which it seeks to protect consumers who use homeopathic medicines. The purpose of this update is to better address issues of homeopathic treatments making claims for curing ailments but not doing so. It covers products that lack clinical efficiency, make unproven medicinal benefits, contain potentially harmful ingredients or fail to meet cGMP guidelines.
King Bio has been under the scanner from January 2018, when the FDA and Federal Trade Commission (FTC) issued a joint Warning Letter to the company for making the false claim of marketing a drug that illegally claimed to prevent, cure or treat opioid addiction.