The U.S. Food and Drug Administration (FDA) sent a strongly worded warning letter that rebuked Raritan Pharmaceuticals earlier this month for making homeopathic teething products with inconsistent levels of a potentially toxic ingredient.
In the warning letter to the president of the New Jersey-based pharmaceutical company, the FDA pointed to significant violations of good manufacturing practices during an inspection from September 29 to October 20 last year.
According to the warning letter sent June 20, the FDA found the manufacturing facility failed to test samples of each component to ensure they fall within the specifications for purity, strength and quality.
“You manufacture Infants’ Teething Tablets from ingredients that pose potential toxic effects,” the FDA wrote in the letter. “Specifically, this drug product contains belladonna and is marketed for vulnerable patient populations, including infants and children under two years of age.”
A sample from the facility detected a variable amount of belladonna, putting patients at risk.
Belladonna, sometimes known as deadly nightshade, is a plant that has been used in homeopathic remedies for hundreds of years. However, the substance can be lethal in larger doses, especially in young children.
On Sept. 30, 2016, the FDA sent a warning to consumers that homeopathic teething tablets and gels could pose a risk to infants and children. The agency recommended that parents stop using products sold by CVS, Hyland’s and other brands.
“Teething can be managed without prescription or over-the-counter remedies,” Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said at the time. “We recommend parents and caregivers not give homeopathic teething tablets and gels to children and seek advice from their health care professional for safe alternatives.”
The FDA said any child experiencing seizures, difficulty breathing, lethargy, constipation, agitation or other symptoms should seek medical care immediately.
Raritan Also Cited For Misbranding Violations
Although homeopathic products are usually separated from drugs, the FDA clarified that the teething tablets are considered drugs because they are intended to diagnose, cure, mitigate, treat or prevent disease.
Some of the marketing for Raritan Pharmaceuticals’ teething products said they were a natural relief of pain and temporarily relieves symptoms of simple restlessness.
“Homeopathic drugs are subject to the same regulatory requirements as other drugs; nothing in the [Federal Food, Drug and Cosmetic Act] exempts homeopathic drugs from any of the requirements related to adulteration, labeling, misbranding, or approval,” the FDA wrote.
The agency said that since the actual ingredients were inconsistent with what was on the labeling, the products were misbranded.
Teething Products Recalled After Inconsistent Belladonna Levels
Raritan Pharmaceuticals initiated a recall of certain teething tablet products shortly after the FDA’s laboratory results indicated that belladonna levels were more than stated on the label.
According to the voluntary recall, three products were affected: CVS Homeopathic Infants’ Teething Tablet, Kids Relief Homeopathic Ear Relief Oral Liquid and CVS Homeopathic Kids’ Ear Relief Liquid. Consumers were encouraged to stop using the products “due to the potential for variation in the content of belladonna extract in the products.”
Although products made by Hyland’s were mentioned in the FDA’s warning last year, the company did not recall its products. Hyland’s stood by its products, calling them safe.
After another warning in October, Hyland’s stopped selling the tablets in the United States but did not issue a recall to warn the public or remove the last products from the shelves.
It wasn’t until a strongly worded letter was issued by the FDA in April requesting an immediate recall of all Hyland’s Baby Teething Tablets and Hyland’s Baby Nighttime Teething Tablets did the company finally relent.
Even after the recall, Hyland’s continued to support its product.
“It is important for you to know that all manufactured and sold teething medicines met the Company’s safety limit tests and all tested product has been well within an established safety threshold,” Hyland’s wrote on its site. “With this recall, Hyland’s is adhering to what its regulating agency has formally requested.”
FDA May Take Action Against Raritan If Violations Not Corrected
In its June 20 letter, the FDA indicated that it could take action against Raritan Pharmaceuticals if the violations laid out in the letter are not corrected in a timely matter.
“Failure to promptly correct these violations may result in legal action without further notice including, without limitation, seizure and injunction,” the FDA wrote. “Unresolved violations in this warning letter may also prevent other Federal agencies from awarding contracts.”
The agency could also withhold approval of pending drug applications made at the facility and re-inspect to ensure completion of corrective actions.
Raritan Pharmaceuticals has to write a response to the FDA within 15 working days to document the changes made to correct the violations and stop them from happening again.