CarraShield Labs, Inc. reported today that with the successful conclusion of the product testing required by the U.S. Food and Drug Administration for approval as a Class II Medical Device, Divine 9® made with CarraShield™ also meets or exceeds all the recommendations for personal lubricants published by the World Health Organization. The World Health Organization (WHO) published an Advisory Note providing four key guidelines for the purchase of personal lubricants. Divine 9 with Carragel meets or exceeds all of the recommended guidelines.
January 6, 2016, Orlando, Florida – CarraShield Labs, Inc. reported today that with the conclusion of the product testing required by the U.S. Food and Drug Administration for approval as a Class II Medical Device, Divine 9® made with CarraShield™ was also shown to meet or exceed all the recommendations
for personal lubricants published by the World Health Organization.
The World Health Organization (WHO), Department of Reproductive Health and Research, in collaboration with United Nations Population Fund (UNFPA), published an Advisory Note providing guidelines for the purchase of personal lubricants. The objective of the WHO Advisory Note was to
establish criteria based on recently published studies that help ensure a lubricant will not weaken condoms, contain any potentially harmful ingredients, or be formulated in a way that negatively effects sensitive tissue inside the body.
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 Carragel was shown by
FDA-approved 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 Carragel 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 Carragel 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.
“The team at CarraShield Labs has been working diligently with independent testing labs to validate the safety of Divine 9 with CarraShield for the FDA,” explained Dean Fresonke, CEO of CarraShield Labs.
“With the data now in hand and validated through our approval as a Class II Medical Device by the FDA, we are gratified to report that we not only meet all the FDA requirements but also meet or exceed the World Health Organization’s published guidelines for personal lubricants.”*