FDA Issues Warning to Homeopathic Manufacturers For Violations

May 29, 19 FDA Issues Warning to Homeopathic Manufacturers For Violations

Despite the fact that the United States is the number one consumer of prescription drugs in the world, that doesn’t mean every American is keen on Western medicine. In fact, there are countless consumers who would rather embrace more holistic approaches to treatment. But what many people don’t realize is that homeopathic remedies come with their risks, too. The U.S. Food and Drug Administration just issued a warning to five different homeopathic manufacturers due to serious violations of good manufacturing practices, illustrating that just because a solution may be natural doesn’t necessarily mean it’s safe.

Nearly 8.5% of the entire U.S. workforce is in manufacturing, a sector that includes 12.75 million manufacturing jobs. While these companies may be good employers, they aren’t necessarily looking out for the best interests of the American public. The FDA issued warning letters to five different companies, four of which work together to produce and package Puriton Eye Relief Drops. Kadesh Inc., U.S. Continental Marketing, Inc., Fill It Pack It, Inc., and Bershtel Enterprises LLC — which together do business as WePackItAll, create and distribute this homeopathic-labeled product. When the eye drops were tested by the FDA, they were revealed to be non-sterile, which could pose the risk of eye infections to consumers. The product also contains a high pH level, which could cause eye injuries like corneal scarring, glaucoma, and loss of vision. Although one of the four companies issued a voluntarily recall in 2018 due to non-sterile production conditions at the manufacturing facility, an additional letter sent by the FDA outlines the current failure of the companies to have a system in place to ensure adequate design, control, and monitoring of the manufacturing process.

According to the FDA, “These unapproved drugs may cause significant and even irreparable harm if they are poorly manufactured, which can lead to contamination, or may contain active ingredients that are not adequately tested or disclosed to patients.”

The FDA also issued a written warning to Newton Laboratories, a company that manufactures products that are meant to treat specific conditions in infants and children. The warning letter contained concerns about manufacturing practices, misbranding violations, and unapproved new animal drug violations. Even scarier, the products are reportedly created from ingredients that could be incredibly harmful to the intended consumer.

“Some of the company’s products labeled as homeopathic…are manufactured from ingredients such as nux vomica, belladonna, aconitum napellus, and gelsemium sempervirents that pose potentially toxic effects,” explained the FDA. “For example, nux vomica contains strychnine, which is a highly toxic, well-studied poison that is used to kill rodents. Producing such a product without proper manufacturing controls may lead to super-potent drugs, which could be a potential poisoning risk for consumers.”

It’s essential for consumers to know that products bearing the “homeopathic” label have not been evaluated or approved by the FDA for use. As such, they may not meet industry standards for quality, effectiveness, and safety. And if these products are manufactured improperly, contamination and/or injury can result for the end consumer. Back in 2017, the FDA proposed a new risk-based enforcement approach to ensure that the agency can prioritize enforcement and regulatory actions concerning products categorized as homeopathic. Health care providers and consumers are encouraged to make a report to the MedWatch Adverse Event Reporting Program concerning any homeopathic products that show signs of quality issues or that have led to any health problems.

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