Online Product Marketplace Cited for Non-Compliant Products
Companies are responsible for the products they distribute
FDA issued a warning letter to an online marketplace that sells international products, including Korean skincare and miscellaneous household items, for distributing motion sickness patches that contained undisclosed drug ingredients. This is an interesting letter which shows that companies are responsible for the products they distribute. Let’s see what we can learn.
Undisclosed drugs in product: FDA tested the product and found it to contain “diphenhydramine, diphenhydramine N-oxide, and diclofenac” that were not listed on the label, which is very concerning. It also appears similar products are sold on marketplaces like Amazon, so expect to see more warning letters to other platforms selling these products. If you are an online distributor, now is the time to ensure all products you distribute are compliant and untainted.
Fulfillment = responsibility. In this letter FDA states that the products were fulfilled by the company, rather than the items being drop-shipped by vendors. In my view, this “handling” aspect is significant because it defines the company’s level of responsibility for the products. This raises the question of whether marketplace platforms that don’t physically touch the products face a lower risk of scrutiny from distributors. FDA has a history of citing marketplaces for the products they handle, as I wrote about in this 2023 Amazon-related post.
From warning letter. “Each of the products discussed in the warning letter was “fulfilled” by IBSPOT; your product listings for each of these products stated, “Fulfilled by IBSPOT.”
Disease claims: FDA also cited disease claims on the product labels.
From warning letter. “Relieve the vomiting, nausea, dizziness, anorexia, and other sickness symptoms caused by taking cars, ships, planes, trains, and other means of transport.”
Read the full warning letter here.
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