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FDA Sets Regulatory Framework for Regenerative Biological Therapies

It's a sign of the times when technology and innovation hit a point where the U.S. Food and Drug Administration must stop and write new rules to ensure consumer safety. That time, with respect to regenerative biological therapies, is now.

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Road to Regulation: Microneedling Devices Defined by FDA

Microneedling devices have, for some time, been without widely enforced regulation. As such, the U.S. Food and Drug Administration released a draft guidance on Sept. 15, 2017, defining when tools are considered esthetic vs. medical in nature, along with potential regulatory changes.

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Talc Results Are In: FDA Releases 6-part Report

The U.S. Food and Drug Administration released the findings from a year-long project to test talc-containing cosmetics for the presence of asbestos. Results showed 43 samples were negative while 9 were positive.

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FDA Sued Over Salon Products Containing Formaldehyde

The groups claim that the FDA has not sufficiently reacted to the concerns regarding the health risks that salon keratin hair products containing formaldehyde present.

FDA Releases Draft Guidance Toward Nanotech Regulation

The US Food and Drug Administration (FDA) has released a draft guidance outlining its view on how to identify whether regulated products contain nanomaterials or apply such technologies.

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What Dermatologists, FDA Say about Halloween Makeup

Spooky makeup fills novelty shops this time of year, but what did dermatologists and other experts have to say about safety and ingredients?

According to data from the Instituto de Comercio Exterior (ICEX), the American market is the market that imports the largest quantity of beauty products from Spain.

Mixer & Pack Receives FDA Registration Under MOCRA

Its facilities are now registered to operate in the United States.

FDA Issues Warning Letter for Injectable Tan Product

The US Food and Drug Administration (FDA) has issued a warning letter to Melanocorp Inc. concerning the sale and marketing of the product Melanotan II.

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FDA Talks Cannabis Next Steps, Announces Public Hearing

The new steps will include the creation of an eternal agency that will explore potential pathways for the lawful marketing of products with CBD.

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Antibacterial Soap? You Can Skip It, Says FDA

The FDA is issuing a final rule under which OTC consumer antiseptic wash products containing the majority of the antibacterial active ingredients—including triclosan and triclocarban—will no longer be able to be marketed.

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FDA Releases Color Additives Q4 Report

The U.S. Food and Drug Administration (FDA) has posted to its website the fourth quarter 2020 report on color additive certifications.

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FDA to Withdraw Temporary Hand Sanitizer Production Policies

"In recent months, the supply of alcohol-based hand sanitizer from traditional suppliers has increased and now, most ... are no longer having difficulty obtaining these products. Therefore, we have determined it’s appropriate to withdraw the temporary guidances..."

FDA Publishes its Draft Guidance for Cosmetic GMPs

The U.S. Food and Drug Administration (FDA) has published its Draft Guidance for Cosmetic Good Manufacturing Practices (GMPs), an update to its Cosmetic Good Manufacturing Guidelines/Inspection Checklist, mostly to include ISO 227 16:2007 as part of an effort to harmonize GMPs internationally.

FDA Warns Brazilian Blowout for Methylene Glycol Formulation

The US Food and Drug Administration (FDA) has sent a warning letter to Brazilian Blowout for its Açai Professional Smoothing Solution. The FDA finds the product to be misbranded by stating on its label that it does not contain formaldehyde and is adulterated by containing methylene glycol, a liquid form of formaldehyde.

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UPDATED: FDA Bans 24 Antiseptic Ingredients Including Triclosan

Along with triclosan, the FDA has banned 23 other ingredients used in health care antiseptics, finding their safety and efficacy insufficient.

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FDA Scrutinizes Food, Drink Packaging of Hand Sanitizers

Beer cans, children’s food pouches and water, juice and vodka bottles are among the types of consumable packaging being used for hand sanitizers and raising concerns with the U.S. Food and Drug Administration.

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FDA to Hold Public Meeting In Preparation of ICCR Meeting

Information gathered from the public meeting will help the FDA prepare for the International Cooperation on Cosmetics Regulation-12 (ICCR-12) meeting to be held July 10-12, 2018, in Tokyo, Japan.

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Methanol Content and How to Test for it: FDA Guidance

The U.S. Food and Drug Administration has outlined a policy for companies to test alcohol (ethanol) or isopropyl alcohol for hazardous methanol content prior to their use in hand sanitizer products.

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