Health, Beauty And Wellness News: Herbalife Q3, NPA On Part 111 Trends, AHPA's Zimmerman Awarded

AHPA's Zimmerman receives AHG's 'Best Contribution' award; NPA notes Part 111 violations common and emerging; saw palmetto BAPP update notes adulteration developments; China results lead Herbalife sales jump; and China deal delay moves GNC Q3 report date.

China results lead Herbalife sales jump

Nearly 30% growth in China led Herbalife Nutrition Ltd. to a nearly 14.3% year-over-year net sales jump to $1.2bn as its global sales volume increased 15%, its largest improvement from a year-ago period in six years. The Los Angeles-based nutritional and weight loss supplement direct seller on Oct. 30 also announced updated its fiscal 2018 guidance for net sales to a range of 9.9% to 10.9% growth and for its reported diluted earnings per share to $1.99-$2.09; Herbalife initiated its FY 2019 net sales guidance at a range of 2.8%-6.8% growth, including around a 220 base point loss from currency exchange. Additionally, the firm announced a $1.5bn share buyback to be completed over five years and that during the July-September period it closed two debts totaling $1.65bn – a $1.25bn credit facility and a $400m senior note – to support its buyback program, which has returned more than $4.5bn to shareholders since 2007. Foreign exchange rates slowed Herbalife across its regions, though the drag wasn't largest in China, where reported sales grew 29.3%, or 27% including currency impact, to $266.5m, according to its earnings release. Its reported/currency-factored growth rates in the US and Canada were 20.2%/20.1% to $240m; in Mexico were 12.8%/6% to $121.2m; in other Asia-Pacific markets were 23.3%/18.8% to $274.3m; in Europe, Middle East and Africa were 16.9%/10.3% to $235.9m; in South and Central America excluding Venezuela were down 0.4%/12.1% to $101.1m.

Sales growth came partly from launching a total of 58 products in 51 countries during the quarter, said CEO Richard Goudis during a same-day earnings briefing. Goudis also noted Herbalife's recent US launch of high-protein iced coffee. (Also see "Health, Beauty And Wellness News: Launches, Petition, Recalls, Ad Campaign, 'Irreparably Defective' SOP" - HBW Insight, 15 Oct, 2018.)"This is a great example of our strategy to help our distributors attract new customers to Herbalife Nutrition by expanding into new categories and by meeting the nutrition needs of a broad range of consumers throughout the day," he said Goudis also noted the launch of a limited-edition caramel apple flavor Formula 1 nutrition product along with a seasonal 10-serving size trial pack with pumpkin spice, pralines and cream and banana caramel flavors.

China deal delay moves GNC Q3 report date

[GNC Holdings Inc.]'s share price jumped some on Oct. 30 in anticipation of the firm's third-quarter results before losing most of the gain when it announced a delay in closing a Chinese firm's $300m investment and postponed until Nov. 9 its sales and earnings statement for the July-September period. The nutrition, health and wellness manufacturer and retailer says it continues to work with Harbin Pharmaceutical Group Co. Ltd. (Hayao) on completing the investment and launching the firms' joint venture in China. Closing the deal awaits approval of foreign exchange registration with China's State Administration of Foreign Exchange and final negotiation and execution of definitive documentation for the joint venture, GNC said. The deal already has approvals from both firms' shareholders, the Committee on Foreign Investment in the United States, China's Ministry of Commerce and its Assets Supervision and Administration of State Counsel. The companies said they expect to close the deal within the timeframe stated in their agreement, by the end of 2018, "but there can be no assurance that the remaining closing conditions will be satisfied or waived within that timeframe."

Pittsburgh-based GNC's share price moved from an Oct. 29 close $3.53 to $3.91 the next day in heavy trading but were down again on Oct. 31 to close at $3.68. In February, GNC announced that Hayao will become the single largest shareholder and the firms will form a JV for manufacturing, marketing and distributing GNC-branded products in China. The agreement expands GNC's board from six to 11 members, comprising GNC Chairman and CEO Ken Martindale, five appointed by both Hayao and five by GNC. (Also see "GNC's New Partner Brings China Access And Funding, Takes Board Seats" - HBW Insight, 14 Feb, 2018.)E-commerce sales in China already are a key driver for GNC. In July, it reported total online sales grew 2.8% and accounted for 8.3% of total US and Canada revenue while its international revenues jumped 11% to $48.6m primarily on a $3.7m increase in China e-commerce sales. (Also see "GNC Links Pipeline To Loyalty Program Trends, Builds Private Label Lines" - HBW Insight, 26 Jul, 2018.)

AHPA's Zimmerman makes AHG's 'Best Contribution'

American Herbal Product Association Chief Information Analyst Merle Zimmermann received the "Best Contribution to Knowledge" award from the American Herbalists Guild for his poster submission on dietary supplement good manufacturing practices inspection and compliance trends at the guild's 29th annual symposium in Georgia, Oct. 25-29. "These types of partnerships help the entire herbal supplement industry understand the regulatory obligations required by US law that are designed to ensure the quality and efficacy of these products," Zimmermann said in an Oct. 30 release.

During AHG's symposium at Unicoi State Park and Lodge in Helen, Ga., Zimmerman provided participants with AHPA resources for good herbal compounding and dispensing practices; good agricultural collection practices and GMPs for botanical materials; guidance on foreign matter limits in herbal ingredients; and for other topics. He also will present FDA's GMP inspection and industry compliance trends during a two-part webinar AHPA is conducting Dec. 4 and 18.

Part 111 violations common and emerging

Failure to determining whether specifications are met for establishing a production and process control system has been the most commonly cited problem across FDA's 10-year history of dietary supplement good manufacturing practices inspections, says the Natural Products Association. Omitting written procedures for production and process control systems, meanwhile, has risen close to the top after starting among the less common problems FDA officials are reporting. Testing specifications for a production and process control system was either No. 1 or No. 2 from 2010 through 2014 among violations of FDA's supplement GMP final rule, codified as 21 CFR 111.75, or "Part 111.75." But it became less common during 2015-2017 and isn't among the top 10 problems reported so far in 2018, NPA said on Oct. 30. The written procedures requirement, Part 111.140, meanwhile, has increased to the No. 2 problem in 2018 after bouncing around in the lower half of the top 10 the previous years. A requirement similar to 111.75, specifications to establish when establishing a production and process control system, 111.70, has remained common among FFDA officials' findings as No. 1 or 2 during 2010-2017 and is No. 3 in 2018, according to NPA. FDA began supplement GMP inspections in 2010 following a three-year compliance phase-in allowed in the 2007 final setting the requirements.

Saw palmetto BAPP update notes adulteration developments

The ABC (American Botanical Council)-AHP (American Herbal Pharmacopoeia)-NCNPR (National Center for Natural Products Research) Botanical Adulterants Prevention Program has published its revised Botanical Adulterants Prevention Bulletin on saw palmetto (Serenoa repens) berry and berry extracts. The American Botanical Council's 2017 HerbalGram Herb Market Report ranked saw palmetto products among the 20 top-selling herbal supplements in the US in both the natural and mainstream retail channels. The groups' initial bulletin on saw palmetto in February 2017 stated that adulteration by adding undeclared lower-cost vegetable oils for financial gain has been known since in the early 2000s and several suppliers have reported the sale of a particularly sophisticated type of adulterated extracts, mainly from suppliers in Asian countries. The adulterated materials partly are made using fatty acids obtained from animal fats and are designed to mimic the fatty acid composition of authentic saw palmetto extracts. The revised saw palmetto bulletin was updated to reflect this newly reported form of adulteration with animal fats. The bulletin is co-authored by Scott Baggett, an analytical methods consultant for the natural products industry, and Stefan Gafner, chief science officer for ABC and technical director of BAPP. The bulletin also provides updated information on the saw palmetto market by adding the latest US sales data and a discussion of the new harvest permit requirements the Florida Department of Agriculture and Consumer Services issued in July.