FDA WARNING_LETTER - Newton Everett/WR Group Inc.

The FDA issued a Warning Letter to Newton-Everett, L.L.C. and W/R Group, Inc. on September 7, 2017, following a July 2017 review of their websites (www.biovea.com, www.neulook.com, www.newton-everett.com) and social media. The FDA determined that ten products—AHCC 500mg, Alpha Lipoic Acid 300mg, Borage Oil 1000mg, Cholest-Rite Advanced, FirstBiotic Advanced, Liverol Advanced, Lycopene 10mg, Odorless Garlic 1000mg, Omega-3 Fish Oil 1360mg, and Xanthadrene—are unapproved new drugs and misbranded drugs under the Federal Food, Drug, and Cosmetic Act.

The violation stems from disease treatment and prevention claims made on their websites, blogs, Facebook, Twitter, and Instagram, which establish the products' intended use as drugs. Examples include claims that AHCC 500mg helps fight HPV, Alpha Lipoic Acid 300mg manages blood sugar and aids liver function, and Cholest-Rite Advanced lowers cholesterol.

These products are considered "new drugs" because they are not generally recognized as safe and effective for their claimed uses, violating sections 201(p), 301