ORLANDO — CarraShield Labs reports 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, its lubricant 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.
Although the WHO has not specifically tested Divine 9, Carrashield Labs says it meets the following recommendations from WHO’s Advisory Note:
“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. CarraShield Labs says its Divine 9 with Carragel was shown by FDA-approved laboratory testing to have an osmolality ranging between 520 and 720 mOsm/kg, a value below the WHO-recommended maximum.
“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. CarraShield Labs says 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.”
According to the company, Divine 9 with Carragel has a pH of 6.5. CarraShield Labs says it 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. According to the company, 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.”
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