Learning targets: Children, risky words, intranasal, ingredient benefits

Warning Letter Wednesday is a cautionary tale for companies new to the space that are looking to market products.

This company looks like a groovy crystal shop that started making topical products and products delivered to the eyes and nose.

So what can we learn?

Of course, there are high risks words referenced in the warning letter, Notably, the use of viruses, cancer, and so many more!

Products delivered through the nose (intranasal) or as an eye drop are drugs and have a justifiable higher level of scrutiny.

Products marketed for use by children are high-risk.

This warning letter is a good teaching tool. Copying and pasting a product’s “therapeutic uses” from a textbook or website is a great way to get into trouble. This appears to be the case here.

From warning letter: Colloidal silver is used to treat infections due to yeast; bacteria (tuberculosis, Lyme disease, bubonic plague, pneumonia, leprosy, gonorrhea, syphilis, scarlet fever, stomach ulcers, cholera); parasites (ringworm, malaria); and viruses (HIV/AIDS, pneumonia, herpes, shingles, warts).

Asa comments: I understand these are obvious high-risk claims, but in some ways, this could have happened to any entrepreneur that doesn’t understand the rules of marketing products. I have seen this happen several times with practitioners, herbalists, and even doctors that “cross the line” into marketing claims by using common therapeutic language such as anti-inflammatory and even “clears heat and resolves toxins.” We talk about this here. 

From warning letter: “…. to heal skin irritations and scarring.”

Asa comments: Interestingly, there are a couple of references to helping skin irritations and scarring. I do not consider these to be high risk. They are likely a “pig pile” or a common secondary claim in warning letters. What are your thoughts on the risk level here?

Read the warning letter here.

In closing, I think the FDA would have left this company alone if there were not talking about viruses, selling products that go into the nose and eyes, are marketed as safe for children, and had just too many disease words to be avoided.

I started a LinkedIn group just for warning letter discussion. Join here.