Microformulation Cosmetic Consulting

07/24/2024

The beauty industry thrives on innovation, constantly evolving to meet the diverse needs and desires of consumers worldwide. Two staples that have seen signific

06/27/2024

The US Food and Drug Administration issued a Warning Letter to Sani-Care Salon Products, Inc., Cartersville, GA. FDA cited several violations, including:

• Failure by the quality control unit to exercise its responsibility to ensure drug products manufactured are in compliance with Current Good Manufacturing Practices (CGMP), and meet established specifications for identity, strength, quality and purity (21 CFR 211.22).

• Failure to have for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release. FDA said Sani-Care also failed to conduct, for each batch of drug product, appropriate laboratory testing, as necessary, required to be free of objectionable microorganisms (21 CFR 211.165(a) and 211.165(b)).

• Failure to conduct at least one test to verify the identity of each component of a drug product. FDA said Sani-Care also failed to validate and establish the reliability of its component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and 211.84(d)(2)).

FDA issues warning letter to US manufacturer of hand sanitizer.

05/15/2024

"In today's scholarly publishing world, researchers are contending with increasing pressures to publish, creating a susceptibility to unethical manipulation through paper mills, peer review rings, and other forms of fraud. This whitepaper outlines the disruptions Hindawi faced and dives into the ongoing efforts to investigate and rectify the scholarly record. Plus, it offers potential solutions for publishers and academic organizations to collaboratively improve journal security and mitigate manipulation for a more secure future in scholarly communication."

https://www.wiley.com/en-us/network/publishing/research-publishing/open-access/hindawi-publication-manipulation-whitepaper

04/11/2024

https://www.nsf.org/knowledge-library/regulatory-impact-modernization-cosmetics-act

NSF's legislative expert outlines the impact of the Modernization of Cosmetics Regulatory Act, or MoCRA, including the FDA's new authorities.

03/27/2024

Decoding the Chemistry: Antiperspirants vs. Deodorants – Formulation Insights

In the realm of personal care products, few items are as ubiquitous and essential as antiperspirants and deodorants. While they both tackle body odor, their mec

03/27/2024

FDA Sends Warning Letters To Six Makers of Topical Pain Relief Products

The agency issues consumer warnings, citing issues including higher concentrations of lidocaine than allowed in OTC products.
https://www.happi.com/contents/view_breaking-news/2024-03-27/fda-sends-warning-letters-to-six-makers-of-topical-pain-relief-products?_hsmi=300065783

03/27/2024

Is your product an over-the-counter drug product
(OTC) or a cosmetic?

🔍 Are you unsure if your product falls under over-the-counter (OTC) drug regulations or cosmetics guidelines?

⚖️ The classification of your product is crucial, and it depends on the ingredients and claims you make.

💄 Lip balms are a prime example – they can serve as cosmetics for beautifying lips or as OTC drugs for skin protection, based on their formulation and stated benefits.

🔬 How do you determine if your product is an OTC drug? It's about meeting the criteria set by regulatory bodies like the FDA and the European Commission.

📝 OTC drugs require specific therapeutic claims and active ingredients within regulated concentration ranges. They undergo rigorous testing and must comply with Good Manufacturing Practices (GMP).

💡 Did you know? OTC products can contain the same active ingredients as prescription drugs but at lower concentrations, suitable for consumer use without a prescription.

🌐 Marketing OTC drugs involves adherence to OTC monographs or drug approval processes, ensuring compliance with all regulatory conditions.

🛠️ Manufacturing OTC products demands adherence to stringent quality guidelines, including rapid microbial detection methods, and thorough documentation of workflows and procedures.

👉 It's vital for manufacturers to understand the regulatory requirements for their products and implement quality manufacturing processes to ensure consumer safety.

🚀 Don't risk compliance issues! Stay informed, adopt GMP standards, and prioritize quality manufacturing to keep your products safe and compliant.

03/21/2024

A formulator’s guide to working with colourants

There is considerable art, as well as science, in developing products that meet consumer demand for attractive and functional cosmetics. Here, Kelly Dobos of the University of Cincinnati, USA sets out the principles of working with three classes of colourants - dyes, pigments and pearlescent effect....

03/18/2024

"Beauty dupe culture is a fixture of the marketplace and a favorite topic for influencers and journalists. They’re also the bane of many brands’ existence.

But are they such a bad thing?"

NielsenIQ's Tara James Taylor argued in her briefing that not only are dupes a major force in the U.S. market, brands that are most duped are typically doing very well.

03/13/2024

The personal care industry is experiencing a transformative shift as brands respond to the growing demand for sustainable and eco-friendly solutions. One of the

03/13/2024

Artificial intelligence (AI) can be defined as the theory and development of computer programs that can do tasks and solve problems that usually require human intelligence. These include visual perception, speech recognition, decision-making and word translation.

Artificial intelligence is increasingly finding utility in beauty for recommending and personalizing products, R&D and even market predictions. This article highlights select examples of how it is advancing cosmetics and personal care products and R&D.

03/13/2024

NPA Says FDA Needs to Focus on the Basics FDA FY 2025 Budget Once Again Includes Mandatory Product Listing.

Year after year, the FDA’s budget proposal includes mandatory product listing. Congress has routinely shut down this proposal, another example of the FDA being distracted from doing the basics.