The FDA does not approve cosmetics, and that includes hair care products.
It's a fact borne out in federal law.
But that hasn't stopped some women who sell Monat from making posts claiming the multi-level marketed hair care products are FDA-approved.
The claims come as the company tries to rebound from a rash of criticism nationwide.
"I literally had almost a baseball size of hair in my hand," said San Diego resident Dana Sohovich. "It's devastating."
Indianapolis-area Licensed Cosmetologist Jessica Deetz spent nearly $300 on a package of Monat products. She said, "It was fine for a couple of months and then all of a sudden hair starts falling out. I started noticing clumps coming out."
She said her kids were having problems after using Monat's junior line.
Regarding her daughter, she says, "She's lost 3/4 of it. Her hair is breaking off. I found massive amounts of hair-- that were concerning--in her crib."
And she says her son, A.J., developed patches of hair loss and painful sores on his scalp.
Though Monat claims to have hundreds of thousands of happy customers and has commissioned clinical tests to prove their products are safe and effective, families across the country are part of a growing group who claim to have had adverse reactions to Monat products.
"It was supposed to strengthen your hair. It was an expensive product and I thought it would help my hair. But instead, I'm devastated," said Phoenix resident Heather Fox.
Customer claims that Monat products can cause balding, scalp sores and hair loss are contained in five class action lawsuits and nearly 200 adverse event reports filed with the FDA over the last six months.
After our investigation aired, Monat Co-Founder Luis Urdaneta posted on Facebook live about the FDA inspecting its facilities in Miami.
Through a translator, Urdaneta said, "They have checked everything: processes, active ingredients, quality of the product, and the report that we have this morning from them that they are leaving the office now, is that everything is fine."
Urdaneta goes on to say, "It warranties that we are doing the things as things need to be done and governmental entities certifying us--certified what we are as a company--and clean, honest in everything we do."
From that, a flurry of posts from market partners claiming Monat products are FDA-approved and the company's own claim--which they posted and subsequently changed--that their facilities "Passed FDA inspections."
While the FDA doesn't approve cosmetics, it can take action if cosmetics are found to be defective.
Regarding Monat, the FDA sent this statement:
"The FDA cannot confirm third-party reports about Monat, Inc. or its products. FDA generally does not comment on open inspections or ongoing investigations. If a cosmetic product appears to be causing a problem, FDA must determine the cause of the problem before taking any potential enforcement action.
Since late August 2017, the FDA has received and is assessing 199 adverse event reports related to Monat hair products. We urge consumers who have experienced problems with cosmetics to contact us. We provide phone numbers for consumer complaint coordinators for each state, and have a web-based reporting form that consumers can either complete online or print out and mail.
The FDA does not have legal authority to require that companies share consumer complaints with us. We rely on open source information, medical providers, and consumers themselves for information about potential problems with cosmetics.
The FDA does not approve cosmetics, nor does it have legal authority to require companies submit cosmetic products for approval. Additionally, companies are not legally required to provide safety data to the FDA for product formulations."
MONAT also issued a statement:
"Monat announced that the FDA conducted a thorough audit of its facilities, manufacturing processes, formulas, labeling and packaging materials, finished and unfinished products, and certain manufacturing records for 6 days over the period of March 12 through March 20.
At the conclusion of the inspection, the FDA representatives informed the company that they found no violations or other matters of significant concern. The FDA added that they saw no 'red flags' on any ingredient Monat uses.
The FDA representatives left a list of 5 minor observations, none relating to formulas or product ingredients. FDA representatives also took samples of finished products and raw materials to be analyzed by the agency. Monat was told that the results of those tests would be available in approximately six weeks.
All Monat formulations use ingredients that the FDA and European Commission in the European Union consider 'safe for their intended cosmetic purpose.'
All Monat formulations are clinically safety-tested by independent labs to ensure that they do not promote irritation and in those tests, no Monat formulation has ever shown any potential to cause irritation.
Click here to see Monat's website which the company created to respond to claims of adverse reactions.
Monat is not BBB accredited.
The BBB recently posted this alert on its website : "In January 2018, BBB received several hundred customer reviews within a 3-day period regarding Monat Global, many of which appeared to be filed by sales affiliates of the business. BBB does not accept reviews from employees or sales affiliates of a business.
BBB has removed all reviews for this business and will not be taking positive or negative customer reviews at this time, due to BBB's inability to confirm the authenticity of all reviews being submitted."