Industry Roundup: Supplement Labeling Guide Corrected, Nu Skin Settles

FDA revises its "Dietary Supplement Labeling Guide" to state that the term "dietary supplement" may be used as the entire statement of identity for a supplement. In a Federal Register notice prepared for March 7 publication, FDA said the guide published in 2005 incorrectly stated that the term "'dietary supplement' by itself" is not considered a statement of identity. The American Herbal Products Association in a March 4 statement said it notified FDA in September 2015 that the guide contradicted agency regulations. "Many dietary supplement products are labeled with 'Dietary Supplement' as the only statement of identity in accordance with FDA regulations. Correcting this guidance will help eliminate any confusion that could lead to unsubstantiated allegations of misbranding," said AHPA President Michael McGuffin.

Direct seller Nu Skin Enterprises Inc. expects final court approval in mid-2016 for a $47m payment to resolve a proposed shareholder class action alleging violations of federal securities laws, following a Feb. 18 court decision denying Nu Skin's motion to dismiss the complaint. According to a Feb. 23 release from law firm Andrews & Springer LLC, plaintiff shareholders claim the company made materially false and misleading statements regarding its operations in China – which they suggest constitutes an unlawful pyramid-selling scheme – failing to disclose that Nu Skin revenues "would be significantly impacted when such practices came to light." In 2014, an investigation by Chinese officials into Nu Skin's business in the country resulted in $540,000 in fines related to registration failures and unsubstantiated product claims, but no violations were cited regarding the company's multi-level marketing model Also see "China Regulatory Probe Slows Nu Skin Growth After Record Year" - Pink Sheet, 18 March, 2014.