Consumer products hang in the balance as FDA & cosmetics industry feud - The Washington Post

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Follow the link below to view a list of personal care products that are involved . . .

Consumer products hang in the balance as FDA and cosmetics industry feud - The Washington Post:

"Negotiations between the cosmetics industry and the Food and Drug Administration have collapsed. The goal was to revise regulations that date to 1938 and ensure the safety of various personal care products that cost Americans roughly $60 billion a year."

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FDA issues draft guidance on nanotechnology

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Updated June 25, 2023:

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GUIDANCE DOCUMENT - Drug Products, Including Biological Products, that Contain Nanomaterials - Guidance for Industry - APRIL 2022 - FDA.gov

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Two draft guidance documents that address the use of nanotechnology by the food and cosmetics industries were issued today by the U.S. Food and Drug Administration.

Nanotechnology is an evolving technology that allows scientists to create, explore, and manipulate materials on a scale measured in nanometers – particles so small that they can not be seen with a regular microscope. The technology has a broad range of potential applications, such as the packaging of food or altering the look and feel of cosmetics.

Press Announcements - FDA issues draft guidance on nanotechnology:


The two draft guidance documents are: “Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients that are Color Additives” and “Guidance for Industry: Safety of Nanomaterials in Cosmetic Products.”

The food draft guidance describes the factors manufacturers should consider when determining whether changes in manufacturing processes, including those involving nanotechnology, create a significant change that may:

• affect the identity of the food substance;
• affect the safety of the use of the food substance;
• affect the regulatory status of the use of the food substance; or
• warrant a regulatory submission to FDA.

The cosmetic product draft guidance discusses the FDA’s current thinking on the safety assessment of nanomaterials when used in cosmetic products. Key points include:

• The legal requirements for cosmetics manufactured using nanomaterials are the same as those for any other cosmetics. While cosmetics are not subject to premarket approval, companies and individuals who market cosmetics are legally responsible for the safety of their products and they must be properly labeled.
• To conduct safety assessments for cosmetic products containing nanomaterials, standard safety tests may need to be modified or new methods developed.

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FDA Compliance & Enforcement - Inspection of Cosmetics: An Overview

FDA Compliance and Enforcement; Inspection of Cosmetics: An Overview:

"Section 704 of the Federal Food, Drug, and Cosmetic Act (FD and C Act) authorizes FDA to conduct inspections of cosmetic firms at reasonable times, in a reasonable manner, and without prior notice in order to assure compliance with the applicable laws and regulations, to determine whether cosmetics are safe and properly labeled, and to identify possible health risks and other violations of the law.

A number of factors affect how FDA determines that an inspection of a cosmetic establishment may be warranted. These factors may include--but are not limited to--the type of products, the significance of consumer or trade complaints received, the company's compliance history, FDA surveillance and compliance initiatives, and agency resources.

Some things to know about inspections: . . . "

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Follow the link above to read the full FDA article.

Although there are no good manufacturing practice (GMP) regulations for cosmetics, the FDA offers a Good Manufacturing Practice Guidelines (Inspection Checklist). Failure to adhere to GMP may result in an adulterated or misbranded product.

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FDA on Tattoos and Permanent Makeup

Updated November 18, 2024

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FDA Webinar on Tattoos and Permanent Makeup (PDF):  'via Blog this'

The FDA hosted a webinar on tattoos and permanent makeup. Bhakti Petigara Harp, Ph.D., of the Office of Cosmetics and Colors, Division of Color Certification and Technology in FDA's Center for Food Safety and Applied Nutrition, provided an overview of the composition of tattoo and permanent makeup inks and the pigments used in them, as well as their regulatory status. Dr. Petigara Harp talked about problems that have occurred with the use of these inks, such as allergic reactions, infections, and scarring, and addressed FDA's response to these occurrences. She also discussed misrepresentation of these inks and pigments as "FDA approved." 

Background:
FDA considers the inks used in intradermal tattoos, including permanent makeup, to be cosmetics and considers the pigments used in the inks to be color additives requiring premarket approval under the Federal Food, Drug, and Cosmetic Act. However, because of other public health priorities and a previous lack of evidence of safety concerns, FDA traditionally has not exercised its regulatory authority over tattoo inks or the pigments used in them. The actual practice of tattooing is regulated by local jurisdictions. In addition, concerns raised by the scientific community regarding the pigments used in these inks have prompted FDA to investigate the safe use of tattoo inks. FDA continues to evaluate the extent and severity of adverse events associated with tattooing and is conducting research on inks. As new information is assessed, the agency will consider whether additional actions are necessary to protect public health.
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Additional Resources:
Tattoos & Permanent Makeup: Fact Sheet - FDA.gov

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