Organic Natural Cosmetics

Janesville, Wisconsin (PRWEB) November 21, 2014

Recent research by the World Health Organization (WHO) [1] suggests that many conventional personal lubricants may actually be putting users at higher risk of contracting sexually transmitted diseases. These findings have triggered a new round of FDA reviews for all personal lubricants being sold in the United States. By December 31, 2015, the FDA will re-review all devices subject to a PMA (Premarket Approval) which includes Personal Lubricants. [2]

The review of the personal lubricant category has drawn comparisons to early investigations into smoking safety. In 1964, the Surgeon General of the US Public Health Service linked higher rates of lung cancer to the widespread use of cigarettes. The World Health Organization’s recent investigations have found similar links between the rapid spread of AIDs in Africa and the mass distribution of condoms and condom safe lubricant – a conclusion that on the surface seems contradictory. [1]

Key ingredients in many conventional personal lubricants are the same as those used in products designed to push a dosage of drug into the body through formats such as “the patch”. As an example, such devices are used to discharge nicotine into the body through a nicotine patch. Thus, one hypothesis is that the lubricant actually contains ingredients that facilitate the passage of STDs through the protective wall of the area rubbed against during sex. [3]

Just as the safety of cigarettes was called into question in the sixties, consumers today need to be aware of the potential link between STDs and the lubricant they take to bed.

The category review is underway, and we can expect to see fewer personal lubricants on the shelf at the end of 2015. To achieve FDA clearance, lubricant manufacturers must pass comprehensive laboratory tests. These tests are designed to ensure that the product meets the appropriate provisions of the Federal Food, Drug and Cosmetics Act for good manufacturing practice, labeling and prohibitions against misbranding and adulteration. All Personal Lubricants must have an FDA 510(k) clearance before they go to market. [4]

The first natural product to achieve FDA clearance under the new protocols is an organic, oil-based, and condom-safe, personal lubricant called Simply Slick, a newcomer brand that has already condemned mainstream manufacturers for putting profit before people – a complaint that could become more mainstream with increased consumer awareness. [5]

What else does the FDA know about the inadequacies of the personal lubricant category? Why has it taken so long for us to question the safety of personal lubricants, a product that is regularly used by millions of Americans? Did the manufacturers know about this and choose to ignore it? [6] [7]

In a study performed by the CSHP at the School of Public Health in Bloomington at Indiana University, they determined that an estimated 65% of women and 70% of men have used a personal lubricant. [8] Consumers need to seriously question their product choices. Don’t put yourself at risk under the pretense that safe sex is really safe.

Contacts

Rob Leary

Simply Solutions LLC

608-563-5556

robl(at)simplyslick(dot)com

http://www.simplyslick.com

http://www.youtube.com/watch?v=pzceav5dQGY

SOURCES:

[1] apps.who.int/iris/bitstream/10665/76580/1/WHO_RHR_12.33_eng.pdf

[2] fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHVisionandMission/ucm384132.htm

[3] ncbi.nlm.nih.gov/pmc/articles/PMC3161103/

[4] fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/premarketsubmissions/premarketnotification510k/default.htm

[5] accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K140304

[6] aboutlawsuits.com/k-y-recall-42469/

[7] justice.gov/opa/pr/justice-department-sues-los-angeles-pharmaceutical-company-over-feminine-health-drug-products

[8] stdcentral.org/SHC/SHC_Reece.pdf

[9] cen.acs.org/articles/90/i50/Studies-Raise-Questions-Safety-Personal.html

Ann Arbor, MI (PRWEB) February 14, 2014

Global public health organization NSF International has launched the NSF Cosmetics and Personal Care Program in response to growing concerns from consumers and retailers regarding adulteration, mislabeling and counterfeiting issues. The new program provides auditing, training, product testing, claim substantiation and certification services developed by NSF to enable manufacturers to improve the quality and safety of their products and retailers to strengthen the oversight of their cosmetic and personal care suppliers.

The NSF Cosmetics and Personal Care Program addresses the needs raised by new legislation, retailer-prohibited chemical lists and manufacturing-related quality issues which have driven rapid changes to the $ 300 billion global cosmetics and toiletries market. Consumer safety concerns also have fueled this need. In fact, a recent independent study conducted on behalf of NSF found that 48 percent of consumers are concerned about the quality and safety of personal care products. To help address these concerns, NSF International developed the NSF Cosmetics and Personal Care Program, which includes:

Good Manufacturing Practice (GMP) Auditing: This program meets the growing demand for third-party verified compliance to cosmetic manufacturing GMP quality standard ISO 22716, which is recognized worldwide and mandated by European regulations. It also encompasses U.S. Food and Drug Administration (FDA) guidance criteria for cosmetic production, laboratory controls and customer complaint handling, which is essential for cosmetics imported into the United States. Manufacturers earn a graded audit that retailers use to qualify and set standards for their suppliers, and that serves as a baseline for continual improvement.

Bundled Audits for Food, Personal Care and Dietary Supplements: Many facilities produce ingredients for multiple product categories spanning food, cosmetics and dietary supplements, each of which has its own set of specific quality and safety guidelines. NSF perform audits to multiple schemes and labeling requirements including dietary supplement GMPs, food safety schemes benchmarked under the Global Food Safety Initiative, ISO 9001 and ISO 14001 in addition to cosmetic GMPs. This eliminates audit redundancy and disruption to production operations while reducing costs.

Testing: This includes testing to verify label claims including “free from” substances like Bisphenol A (BPA), PABA (p-Aminobenzoic acid), sulfates, parabens and many others. NSF also screens cosmetics for contaminants to verify their safety and quality. This is in addition to substantiating compliance to regulations in Europe and the U.S. (e.g. Proposition 65). Label reviews and physical, chemical and performance characteristic comparisons against national brands are also available for retailers that have concerns regarding their private label cosmetics and personal care product lines.

Product Certification: NSF certifies cosmetics to widely accepted programs, including the EPA’s Design for the Environment (DfE) program, which verifies that cosmetic products and ingredients do not contain chemicals of concern such as known carcinogens or reproductive and developmental toxicants. NSF International also certifies cosmetics to either the USDA National Organic Program (NOP) or the American National Standard for personal care products containing organic ingredients (NSF/ANSI 305) via NSF’s sister company QAI. These programs are important to safety-minded consumers in particular as a recent independent study conducted on behalf of NSF found that 44 percent of consumers prefer products that are independently tested and certified.

Training and Consulting: NSF provides GMP training for professionals who are involved in manufacturing and distributing cosmetic and personal care products so they can stay apprised of the changing regulatory landscape and best practices in supply chain quality. Those professionals who know how to conduct gap analyses and identify regulatory noncompliances before they become an issue will add value to the manufacturing process, and also help minimize safety and quality risks. NSF can also provide expert consulting to evaluate a cosmetic manufacturing quality and safety system, help facilities resolve complex quality problems or guide companies through the proper procedures for responding to FDA warning letters.

“The cosmetics industry is becoming increasingly scrutinized as consumers seek safer products and retailers step up to meet this demand,” said Casey Coy, Manager of NSF International’s Cosmetics and Personal Care Program. “With this new program, NSF International has applied 70 years of technical and scientific expertise to develop specialized auditing, testing and certification programs that support retailers in improving their supply chain oversight and cosmetic safety. This program also helps manufacturers demonstrate compliance to retailer requirements and U.S. and European regulations.”

To learn more about the NSF Cosmetics and Personal Care Program, please contact Casey Coy at cosmetics(at)nsf(dot)org or +1 734-904-2995.

Media Contact: To schedule an interview with an NSF cosmetic or personal care expert, contact Kelly Ingerly at media(at)nsf(dot)org or +1 734-827-6850.

About NSF International: NSF International is an independent global organization that writes standards, and tests and certifies products for the food, water, health sciences and consumer goods industries to minimize adverse health effects and protect the environment (nsf.org). Founded in 1944, NSF is committed to protecting human health and safety worldwide. NSF International is a Pan American Health Organization/World Health Organization Collaborating Center on Food Safety, Water Quality and Indoor Environment.

NSF International’s Cosmetics and Personal Care Program provides auditing, ingredient and product testing and certification, and training and education for the cosmetic and personal care industries throughout the entire product lifecycle. NSF International developed the only accredited American National Standard for personal care products containing organic ingredients (NSF/ANSI 305) and provides verification of cosmetic and personal care ingredients to the Environmental Protection Agency’s Design for the Environment (DfE) program.