Posted 10 September 2019 | By
The letter for Enprani, which follows a five-day inspection last March, shows how the company released multiple over-the-counter (OTC) drugs products to the US without testing the active ingredient for identity and strength.
The firm’s quality unit also “lacks adequate oversight for the manufacture” of certain OTC drugs, the names of which are redacted in the letter. Enprani was placed on import alert on 15 July.
FDA further noted labeling concerns and said the company had failed to fulfill its registration and listing obligations.
Similarly, FDA found that Hangzhou Badi Daily Use Chemical Company, which was placed on import alert on 30 July, released multiple OTC drugs to the US market without providing any data to show that identity and potency testing had been performed for the active ingredient.
The Chinese company, which said it ceased production of drugs for US distribution, also manufactures drugs containing glycerin, so the company’s failure to analyze each lot of glycerin “to determine whether diethylene glycol (DEG) or ethylene glycol (EG) is present puts patient at risk,” the letter says.
In addition, Hangzhou did not conduct process performance qualification studies, nor did it have a “rigorous ongoing program for monitoring process control to ensure stable manufacturing operations and consistent drug quality.”
The three warning letters sent by FTC target CBD products that claim to treat or cure serious diseases and health conditions.
One of the companies even goes so far as to claim that CBD has been “clinically proven” to treat cancer, Alzheimer’s disease, multiple sclerosis, fibromyalgia, cigarette addiction and colitis, and the company states it has participated in “thousands of hours of research” with Harvard researchers, FTC said.
Another company’s website promotes its CBD gummies as highly effective at treating “the root cause of most major degenerative diseases, including arthritis, heart disease, fibromyalgia, cancer, asthma, and a wide spectrum of autoimmune disorders,” FTC added.
FTC and FDA in March sent joint warning letters to three CBD marketers. And FDA in July sent a warning letter to another CBD marketer making unsubstantiated claims, although this “whack-a-mole” approach may prove to be a difficult way to regulate the CBD industry considering how many of these marketers operate in the US.