FDA Slams Homelab Inspections Reveal Adulterated Teething Products

Aug 20, 2017
Paul M. da Costa

Manufacturers of any products subject themselves to product liability for what they produce and subsequently sell to the public.  Particularly when baby products are at issue, manufacturers need to take extra precautions to ensure that they are safe for infant consumption.  The Food and Drug Administration (“FDA”) is responsible for ensuring the public’s safety by sanctioning companies that are negligent in their manufacturing processes.  The following example highlights not only the FDA’s regulatory power, but the dangers posed by companies who do not maintain safe and acceptable standards in the manufacturing of their products.  

Homeolab USA is currently under fire by the FDA for significant violations and poor quality control discovered during a recent inspection.  Specifically, the Canadian-based homeopathic pharmaceutical manufacturer’s infant teething products contain the lethal poison belladonna.  The agency made clear, however, that Homeolab is merely a private label distributor with no manufacturing capabilities, but that it has an agreement to function as its contract manufacturer.        

The FDA’s website specifically outlined a list of violations in the company’s manufacturing quality and process defects, and labeled the resulting products “adulterated.”  Among the defects, the FDA asserts the company failed to test the quality of its ingredients and does not have manufacturing processes to ensure consistent ingredient levels.  The FDA warns that such finished drug products are especially dangerous for infants, as they are more susceptible to the toxic effects of belladonna.  

The FDA’s revelations culminated after years of investigating reports of babies having seizures, losing consciousness, or even dying in some cases as a result of consuming these products.  The Administration’s first signs of danger came last September as it issued warnings for consumers to stay clear of the homeopathic teething gels. 

Unfortunately, Homeolab is not the only culprit in the industry.  Hyland has also been targeted by the FDA for the same manufacturing defects, and the company ultimately ceased production and distribution in the US in April.  Raritan Pharmaceuticals similarly recalled three of its teething products after a warning by the Administration.  Homeolab, however, makes the powdered ingredients for Raritan, and now suffers the consequences from the public outcry and inevitable lawsuits coming their way. 

To make matters worse, the agency also noted that the company obstructed an inspector from documenting photographs of excess material stuck to the sides of a piece of manufacturing equipment.    

The dangers posed by these products, as highlighted by the FDA, caused retail and pharmacy juggernaut, CVS, to remove Homeolab’s products from its shelves.  Other companies are quickly moving in the same direction.

If you believe your child has been exposed to dangerous toxins as a result of using teething products, please contact Paul M. da Costa, Esq. at Sarno da Costa D’Aniello Maceri LLCCall us today at 973-274-5200.