Pharmavite LLC, Northridge, CA, has responded to a challenge from the National Advertising Division (NAD) of the Council for Better Business Bureaus regarding the company’s Prenatal Multi + DHA.

The company employs stringent standards to manufacture Nature Made brand dietary supplements, ensuring consumers’ satisfaction with effective science-based products, it said in a statement. Pharmavite’s Nature Made Prenatal Multi + DHA Liquid Softgels meet all FDA and U.S. Pharmacopeia (USP) standards for folic acid-containing prenatal products with related health claims. The company has complete confidence in Nature Made’s Prenatal Multi + DHA Liquid Softgels and that the folic acid in this product is available for absorption by expectant mothers.

As applied to soft gels containing folic acid, NAD questioned the relevance of the FDA-adopted USP dissolution standard. NAD is recommending dissolution testing under conditions that recreate the in vivo human digestive system environment, even though the current standard USP dissolution tests for dietary supplements, including prenatal tablets, do not involve test conditions that simulate the in vivo human digestive system environment.

“Despite NAD’s decision that the FDA-adopted USP standard is not adequate to support our folic acid claim, Pharmavite stands by its Nature Made Prenatal Multi + DHA Liquid Softgels as providing adequate and available levels of folic acid for absorption in the body,” the company said. “The NAD’s decision is based on a competitor challenge and is not based on any failure of the Pharmavite product to meet existing FDA or USP standards for folic acid dietary supplements.”

Pharmavite is directly addressing the NAD recommendation by conducting the additional product dissolution testing requested by the NAD to verify the level of folic acid available for absorption in its prenatal supplement in conditions that recreate the human digestive tract environment. Testing has been completed in conjunction with an expert independent research organization using a Dynamic Gastric Model and Static Duodenal Model, which demonstrates that the folic acid in Nature Made Prenatal Multi + DHA Liquid Softgels is available for absorption at levels exceeding that required by the USP standard and effectively meets the current recommendations for pregnant women.

Further confirmatory testing is planned in addition to the confirmatory testing that has been done using a more conventional dissolution apparatus and solutions that mimic gastric and intestinal fluids. “Pharmavite has completed more testing on this product than is required by FDA or USP for either tablets or soft gels,” according to the company. “Nature Made Prenatal Multi + DHA Liquid Softgels perform as we say they do.”