The National Advertising Division of the Council of Better Business Bureaus has recommended that Pharmavite LLC, discontinue marketing “Nature Made Prenatal Multi + DHA Liquid Softgels” as “complete” prenatal vitamins until the company conducts further testing to establish the bioavailability of folic acid in the product. Pharmavite has agreed to do so.

NAD, the advertising industry’s self-regulatory forum, examined advertising and labeling claims for the product following a challenge by Perrigo Company, maker of competing dietary supplements.

The claims at issue include:

“Formulated for Easy Absorption.”

“Nature Made knows that pregnant and nursing moms have special health needs for the development of their child. That’s why Nature Made offers the first OTC supplement that combines a prenatal multivitamin with DHA in one single softgel.”

“Now, you can simply swallow one single softgel to receive the daily dosage of nutritional support recommended for pregnant and nursing moms.”

“Nature Made Prenatal + DHA Liquid Softgel is formulated with 23 key vitamins, minerals, and essential Omega-3 Fatty Acids that may benefit the neurological development of the fetus and health of the mother during pregnancy and may reduce the risk of having a child with brain or spinal cord birth defects.”

Also at issue was a claim in the Supplement Facts section of the labeling for the advertised product, representing that it provides “800 micrograms (“µg”)” of folic acid, described as “100% Daily Value for Pregnant and Lactating Women.”

The product is a dietary supplement multivitamin that includes a wide range of vitamins and minerals, as well as folic acid and DHA omega 3. NAD noted in its decision that there is consensus in the scientific community that folic acid, when taken by women before becoming pregnant and during pregnancy helps reduce the risk of neural tube defects in newborn infants. Therefore, physicians routinely recommend that women who are pregnant, or trying to become pregnant, take folic acid either in an over-the-counter supplement or by prescription.

At issue for NAD in this proceeding was whether the folic acid in Nature Made Prenatal Multi + DHA Liquid Softgels had been shown by competent and reliable scientific evidence to be fully bioavailable to the user.

In reaching its conclusions, NAD examined evidence that included relevant federal guidelines and materials and information prepared for the United States Pharmacopeial Forum in 2009 that addressed how softgel supplements should be tested for bioavailability.

Following its review, NAD determined that while the advertiser has undertaken certain testing to establish bioavailability, the evidence in the record did not support claims that the product is a “complete” prenatal supplement or claims related to absorption. NAD recommended the advertiser discontinue such claims.

The company, while asserting its confidence that the “folic acid in its product is available for absorption,” stated that it accepted NAD’s recommendation.