Success Marked By Market Leadership, Intellectual Property and Extreme-Quality Standards for Ingredients and Manufacturing
SANTA CLARITA, CALIF., May 1, 2023 — CC Wellness — a recognized leader in FDA 510(k) pre-market certification and top-tier pharmaceutical firm that specializes in the development of Class II medical devices as well as cosmetic, OTC, and organic products — has won a Bronze Stevie® Award in the Most Innovative Company of the Year category of the 21st Annual American Business Awards®.
“This award underscores our dedication to innovation and changing the discourse about intimate wellness,” CC Wellness Chief Marketing & Strategy Officer Mimi Anderson said. “We celebrate shame-free intimate wellness as a pillar of health and are leading the category into a judgment-free era.”
Innovation at CC Wellness (CCW) flows from strategic planning and formula-based ideation. Anderson noted that while brand value is where most consumer product goods companies have placed their bets, CCW recognizes that the real value is in formulations not brands — shattering the brand-based business model by prioritizing formulas. “As a result,” she said, “CC Wellness possesses huge hidden value in the formidable intellectual property found in our formulas sold via our flourishing white label business to other brands, including those of many CPG multinationals.”
Anderson added: “Consumers, too, are prioritizing preferences based on the formula in the bottle as much as on the brand label. Our brands and white label partners are benefiting from an educated consumer and likewise consumers are benefiting from the accelerated innovation in CCW formulas.”
Anderson noted: “We have an incredible record of innovating FDA 510(k)-cleared formulas, a certification which means the FDA agrees that the manufacturer’s medical device is safe and effective.”
This legacy of innovation has resulted in CCW holding 24 personal lubricant FDA 510(k) certifications, the most of any white label manufacturer and second only to CPG giant Reckitt.
Emblematic of CCW leadership in product manufacturing innovation in the intimate wellness sector is its enterprise-wide embrace of the concept of “extreme quality.”
CCW has its own consumer brands — #LubeLife, JO, and Muse Health, as well as recently acquired premier brand Shibari, one of the top-selling lubricant labels on Amazon — separate from its thriving Make Waves white label business.
Anderson said that its drive for innovation has fostered industry-leading best practices for sourcing extreme quality in formulas delivered to its white label manufacturing partners and brands. Extreme quality is a big part of why CCW has had zero recalls and a nearly zero complaint rate.
These best practices include: complying with ISO 13485 international standards governing manufacture of medical devices (personal lubricants are classified as Class II medical devices); auditing every vendor, whether for raw materials, components, or labels, and including certifications of clinical and analytical labs that conduct safety testing; sourcing U.S. and E.U. ingredients, which meet more rigorous standards; and conducting ISO 13485-certified level of scrutiny in monitoring of Pharmacopeia-grade ingredients at every stage, in every batch; qualifying vendors by validating raw ingredients using state-of-the-art lab sampling, including rapid microbial testing and infrared spectrometry; and adopting a continuous improvement methodology.
Finally, CCW is bringing quality checks in-house, by expanding its lab from 2,000 to 12,000 sq. ft. in a new 215,000 sq. ft. FDA-licensed and ISO-certified facility that will be the largest white label “Made in USA” manufacturing plant in the intimate wellness industry.
About CC Wellness
Founded in 2003, CC Wellness is a world-class pharmaceutical company specializing in the development of Class II medical devices as well as cosmetic, OTC, and organic products. We celebrate shame-free intimate wellness as a pillar of health and are recognized as a market leader within the category given our unrivaled technical expertise and portfolio of innovative, disruptive and high-quality brands. A leader in FDA 510(k) premarket certification and ISO-certified manufacturing, we pride ourselves on going beyond industry standards for quality and safety and use only U.S. Pharmacopeia-grade ingredients. Due to our strict testing and validation manufacturing procedures, we have never had a recall. Our two divisions:
- Consumer intimate wellness and personal care brands include, #LubeLife the #1 consumer-rated personal lubricant brand on Amazon, JO the #1 intimate wellness brand in U.S. specialty retail, and Muse Health hand sanitizers.
- Make WAVES white label service provides turnkey and white label formula development to partners across FDM (food/drug/mass) retail, specialty retail, and e-Commerce channels.
More About 2023 American Business Awards® Stevie Awards
Stevie Awards are conferred in eight programs. Stevie Awards competitions receive more than 12,000 entries each year from organizations in more than 70 nations. Honoring organizations of all types and sizes and the people behind them, the Stevies recognize outstanding performances in the workplace worldwide. Learn more about the Stevie Awards at http://www.StevieAwards.com.
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