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FDA inspection finds 'insanitary conditions' at Monat manufacturing facility

Posted at 5:24 PM, Aug 20, 2018
and last updated 2018-11-21 16:56:22-05

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

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."  

But 11 lawsuits and about 300 adverse event reports filed with the FDA say otherwise.

"I literally had almost a baseball-size of hair in my hand," said Dana Sohovich of San Diego. "It's devastating."

"She's lost three fourths of it. Her hair is breaking off," Indianapolis resident Jessica Deetz said about her young daughter. "I found massive amounts of hair -- that were concerning -- in her crib."

"It was supposed to strengthen your hair. It was an expensive product and I thought it would help my hair," said Phoenix resident Heather Fox. "But instead, I'm devastated."

We introduced you to all three of those women and their concerns back in March. They're among a long list of consumers who say Monat products ruined their hair.

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

The products are advertised to promote hair stability and growth but multiple lawsuits across the country claim customers have experienced "Significant hair loss or thinning and other complications such as itching, scalp irritation, sores and cystic acne after using Monat products."

"I cannot sell something that does this to women, men, children. It was extremely hard to deal with," said Las Vegan Erin Ostby, who used to sell Monat as one of its market partners.  

She stopped after losing her own hair.

"My dad used to always say I was like Samson from the Bible -- I got my power from my hair," said Ostby. "So it was really upsetting and I couldn't do that to someone else."

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 work day." 

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 insanitary 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 the additional 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 hair or 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 Combability Measurements Clinical Study

MONAT Damage Reduction Clinical Studies

MONAT Tensile Properties of Hair Fibers Clinical Studies

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