/, Divine 9 Personal Lubricant Medical Research/FDA Approves Divine 9® with CarraShield™ Personal Lubricant as a Class II Medical Device

FDA Approves Divine 9® with CarraShield™ Personal Lubricant as a Class II Medical Device

Executive Summary
CarraShield Labs, Inc. announced today the U.S. Food and Drug Administration (FDA) has completed its evaluation of Divine 9® personal lubricant made with CarraShield™ and has approved it as a Class II Medical Device. Divine 9 with CarraShield is the first and only personal lubricant formulated with carrageenan, a type of sea algae extract, to be FDA-approved. The official notification can be found on the FDA website.

January 6, 201 6, Orlando, Florida – CarraShield Labs, Inc. announced today the U.S. Food and Drug Administration (FDA) has completed its evaluation of Divine 9® personal lubricant made with CarrraShield™ and has approved it as a Class II Medical Device. Divine 9 with CarraShield is the first and only personal lubricant formulated with carrageenan to be FDA approved. Carrageenan is a sea algae extract used in many food products and CarraShield Labs has developed a proprietary carrageenan called CarraShield specifically for use in personal lubricants.

In order for a personal lubricant to be marketed and sold in the United States, the FDA now requires all lubricants to have a Class II Medical Device 51 0(k) clearance. A 51 0(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective as other products already on the market. CarraShield Labs used independent laboratories to show that Divine 9 personal lubricant meets stringent safety and performance standards. Divine 9 with CarraShield successfully completed a complex battery of tests that included:

• Condom compatibility
• Antimicrobial
• Effectiveness
• Microbial presence
• Preservative effectiveness
• Vaginal irritation
• Acute system toxicity
• Cellular toxicity
• Skin sensitivity
• Vaginal irritation
• Osmolality

The official notification of the approval of Divine 9 with CarraShield can be found on the FDA website. The FDA has been systematically reviewing all personal lubricants on the market with the intent of requiring products labeled as a “personal lubricant” to obtain a 51 0(k) status. “With the FDA requirements so strict and the testing process so demanding, we believe many products that call themselves a personal lubricant will soon be off the market. “While supplying the necessary data was demanding, we knew our naturally-derived products would easily meet the required safety standards.”

The WHO Advisory Note made the following recommendations:

“When procuring water-based lubricants, the osmolality should preferably be 1200 mOsm/kg or less.”

Studies referenced by WHO in the Advisory Note suggest that lubricants with high osmolality might cause damage to the walls of the vagina and anus. Divine 9 with Carrashield was shown by FDAapproved laboratory testing to have an osmolality ranging between 520 and 720 mOsm/kg, a value far below the WHO-recommended maximum. This result establishes Divine 9 as one of the few Class II Medical Device-approved lubricants on the market that meets this particular requirement.

“Lubricants containing polyquaternary compounds should be avoided until there is further evidence on the effect of polyquaternium compounds on HIV replication rates.”

The WHO cited studies that suggest polyquaternium compounds may enhance the replication of HIV. Polyquaternium compounds are used in some silicone-based lubricants. Divine 9 with CarraShield contains no polyquaternary compounds specifically, and no silicone-based ingredients in general. The primary ingredients in Divine 9 are a natural sea algae extract and purified water.

“For lubricants intended primarily for MSM (men who have sex with men) or where the nature of the intended use cannot be ascertained, a pH in the range 5.5 to 7 is recommended. Lubricants with pH exceeding 7 are not recommended.”

Divine 9 with Carrashield has a pH of 6.5. CarraShield Labs uses natural citric acid to precisely adjust the pH in every batch.

“The bulk procurement and distribution of lubricants containing spermicides, medicinal and other active substances is not recommended.”

The Advisory Note cites studies that suggest spermicides (predominantly nonoxynol-9) have significant irritation issues and that medicinal additives such as benzocaine (to reduce sensation) have additional regulatory requirements as medicines. The Advisory Note goes on to state that non-medicinal additives that claim to create stimulating, warming, tingling or other effects have not been adequately studied to determine their safety in high risk groups such as MSM and sex workers. Divine 9 with Carrashield contains no spermicides, no medicinal additives nor does it contain any type of herb or chemical that attempts to create stimulating, warming, tingling or other effects.