The story of the allegedly toxic (and potentially lethal) homeopathic teething products continues. The latest piece of the puzzle is the multiple violations an FDA investigation uncovered at Raritan Pharmaceuticals, one of the company's manufacturing facilities.
Homeopathic products look just like the medicines they are placed next to on the shelves. However, when it comes to how these products are made - they are vastly different.
This is being brought to center stage through an investigation by FDA into Raritan Pharmaceuticals. If that name sounds familiar, it's because they are one of the companies involved in the homeopathic teething products scandal that allegedly resulted in the illnesses and deaths of infants.
The inspections resulted in two warning letters sent to the company.
The first warning letter, sent on June 20 of this year, was to Raritan Pharmaceuticals. During an inspection of their facility in New Jersey in the fall of 2016, FDA found "significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals."
Because Raritan produced infant teething tablets during this time, this means that 1) the teething tablets were adulterated (there is something in there that shouldn't be in there) and 2) the teething tablets were misbranded (the labeling does not accurately reflect what is in the product).
Some of the specific violations were
- Violation #1 - Failure to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality.
This first one is particularly important because the teething tablets contain belladonna - a substance that is well known to be highly toxic. In addition, when FDA independently tested the teething tablets, they found variability in the products and a much higher amount of belladonna than indicated on the label. In drugs that are being given to infants and children under two, this is incredibly dangerous.
- Violation #2 - Does not have adequate written procedures for production and process controls designed to assure that the drug products you manufacture have the identity, strength, quality and/or purity they purport or are represented to possess.
In other words - the processes that they follow for drug production are not scientifically sound or data driven. Without a standard, any variations could not be detected.
- Violation #3 - Failure to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet its specifications, whether or not the batch has already been distributed.
So, even though a consumer made a serious complaint about the product - which was seizures - there were no results available from sending the samples to quality control (QC).
I don't know which of these violations makes my blood boil more. The fact that they didn't bother to test what they were selling. Or, even if they had wanted to test - their systems in place were so shoddy that they would not have given accurate information. Or, that a parent bought these tablets trying to help their baby, which resulted in seizures, and Raritan didn't even take their complaint seriously.
Lastly, FDA states that “Homeopathic Infant’s Teething Tablets” is a drug because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or because it is intended to affect the structure or any function of the body."
Some of Raritan's claims on these products are
• “Natural relief of pain & irritability from teething”
• “Temporarily relieves the symptoms of simple restlessness and wakeful irritability due to cutting teeth.”
• “Helps reduce gum redness and pain.”
If it is a drug, then false or misleading labeling can lead to it being misbranded. In the world of FDA, misbranding is a word to fear because it is a prohibited act to introduce or deliver for introduction into interstate commerce a misbranded drug.
So, another important piece of the puzzle in the homeopathic teething story is put into place. But, the story will continue. In fact, FDA also inspected the company that distributes the in-powder blends that Raritan uses. What FDA found there is even sketchier than what they uncovered at Raritan. Look for that story in a follow up article coming soon.