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FDA inspection finds 'insanitary conditions' at Monat manufacturing facility

New Palestine mom says hair fell out in clumps
Posted at 9:42 PM, Sep 03, 2018
and last updated 2019-04-12 20:38:58-04

NEW PALESTINE, Ind. -- As consumer complaints about hair loss and scalp sores were piling up across the country, the Food and Drug Administration sent inspectors to the Florida facility where Monat products are made, and a federal report shows inspectors found "insanitary conditions."

A New Palestine mother told RTV6 in March the popular hair product left her hair falling out in clumps, and also caused damage to her children’s hair and scalps.

READ | New Palestine mom says product left hair falling out in clumps

“It was fine for a couple of months, and then all of a sudden hair starts falling out,” Deetz said. “I started noticing clumps coming out, and I would have to clean out my brush every day or two with all the hair loss I had.”

Monat claims its ingredients and products are safe. They point to new testing they paid for showing their products are "non-irritating, hypoallergenic and dermatologically safe for their intended use on all skin types."  

The products are advertised to promote hair stability and growth, but multiple lawsuits and about 300 adverse event report filed with the FDA from customers across the country claim they have experienced "significant hair loss or thinning and other complications such as itching, scalp irritation, sores and cystic acne after using Monat products."

Deetz has not filed a lawsuit, but said her children also experienced problems after using Monat’s junior line, which claims to be “gentle for children ages one to nine.”

“My daughter’s hair is breaking off,” Deetz said. “I found massive amounts of hair that were concerning in her crib. I’ve been massaging her scalp to try to wake up those dormant hair follicles, and I don’t see any new hair sprouting out.”

READ | New Palestine mom says product left hair falling out in clumps

In March, the FDA sent inspectors to B & R Products -- Monat's Miami-area manufacturing plant.

Several months later the FDA released this report which found Monat cosmetics being "prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth."

The report notes multiple products were at risk of cross-contamination due to open reactor lids and missing protective caps on hoses used to pump product.  

A reactor ready to process a new batch of hair care product still had old product residue even after being cleaned multiple times by facility staff.  

And "empty containers of Rejuvabeads were left uncovered and exposed in the filling line after employees finished their workday." 

In March, before the FDA's report was released, Monat Co-Founder Luis Urdaneta posted a Facebook live video about the inspection.

He said, "And the report that we have from them that they are leaving the office now is that everything is fine... It warranties that we are doing the things as things need to be done."  

An FDA legal expert we spoke to says the government report falls on the mild side of the enforcement spectrum and notes fairly common issues but does demonstrate some minor violations of the Federal Food, Drug and Cosmetic Act.

Monat says the FDA's report contains "Nothing of significant concern."  

A spokesperson claims it's like the manufacturing facility getting a grade of A or A-minus. But the FDA says it would never assign a grade.

The FDA does not approve cosmetic products or certify product safety or quality, but the agency did take samples of Monat products for further testing.  

So far, there is no evidence that contamination resulted from the conditions.  

All the lawsuits against Monat have been consolidated in a Florida court, and the legal action is ongoing.

The FDA urges consumers who have experienced problems with cosmetics to contact the agency using the MedWatch reporting system.

More information from Katie Olivier of Sunwest Communications, public relations for Monat:

"I’m sure you’re aware of theadditional product testing that MONAT proactively participated in and subsequently released at one of the world’s leading independent clinical testing labs, Kosmoscience Ciência & Tecnologia Cosmética Ltda, an ISO 17025-certified laboratory in Brazil that specializes in skin and hair care product testing. Kosmoscience has tested products for more than 2,000 companies including L’Oréal, Unilever, Proctor & Gamble, and Johnson & Johnson over the past 15 years.

"On March 14, 2018, the results of three, independent clinical tests were released and confirm MONAT hair products are effective and do not promote hair breakage or further hair damage. The lab tests evaluated whether MONAT products cause hair damage, weaken hair, or promote tangling, which are three common risk factors for increased hair loss and hair damage. The results showed no damage to the surface of the hair or the weakening of hair’s physical strength as a result of using MONAT. Additionally, the lab concluded that MONAT products made hair easier to comb. Furthermore, the studies concluded that double processed hair, as well as flat ironing, were the two primary contributors to hair damage and the MONAT products tested mitigated such damage."

Monat's line is sold mostly on social media through multi-level marketing.  

MONAT Combability Measurements Clinical Study

MONAT Damage Reduction Clinical Studies

MONAT Tensile Properties of Hair Fibers Clinical Studies

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