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Herbalife Beats Sales Forecast, FDA Extends Deadline for Compliance With Nutrition Facts Label

Herbalife Nutrition this week reported a strong first quarter, while FDA extended the deadline for compliance with the Nutrition Facts label. Meanwhile, the leader of the Office of Dietary Supplements within the National Institutes of Health has announced his retirement after nearly 20 years on the job.

Editor’s note: Below is a weekly roundup of health and nutrition developments.

Herbalife Nutrition Beats Sales Forecast

Herbalife Nutrition Ltd. beat expectations for the first quarter and returned to growth in the United States, where it agreed in 2016 to restructure its business model after being investigated by the Federal Trade Commission (FTC).

The Los Angeles-based company posted earnings per share (EPS) of $1.08 on net sales of US$1.18 billion. In the first quarter of 2017, Herbalife Nutrition posted EPS of 98 cents on $1.10 billion in sales.

Analysts surveyed by FactSet had estimated earnings of $1.11 a share on revenue of $1.12 billion, MarketWatch reported.

“We reported higher than expected results and returned to growth in the U.S., reflecting the efforts of our entrepreneurial distributors, who are meeting the needs of consumers around the world,” Rich Goudis, Herbalife CEO, said in a statement.

In North America, Herbalife Nutrition reported net sales of $231.2 million, an increase of 0.6 percent over the year-ago quarter. In 2016, Herbalife agreed to restructure its business operations in the United States under a consent decree entered with the FTC in U.S. District Court in California.

In a Securities and Exchange Commission filing, the company predominantly attributed sales growth in North America to price increases (roughly 3 percent) in the United States that took effect in March 2018. In the United States, net sales increased $0.8 million, or 0.4 percent, to $225.5 million.

In EMEA (Europe, the Middle East and Africa), sales increased 18.3 percent to $248.2 million, while sales in China ($212.2 million) and South and Central America ($119 million) declined 1.6 percent and 0.6 percent, respectively.

The results in South and Central America exclude Venezuela, which the company said represents less than 1 percent of its consolidated net sales and was affected by “significant price increases and erosion in foreign currency exchange rates.”

Herbalife Nutrition is a multi-level marketer of weight loss shakes, nutritional supplements and other products. As of March 31, 2018, the company sold products in 94 countries throughout the world.

FDA Extends Deadline for Compliance With Nutrition Facts Label

FDA this week published a rule that extended by about 1½ years the deadlines for compliance with its Nutrition Facts label and serving size rules published in May 2016.

The agency extended the dates from July 26, 2018 to January 1, 2020 for manufacturers with at least $10 million in annual food sales, and from July 26, 2019 to January 1, 2021 for manufacturers with less than $10 million in annual food sales.

“This extension on the Nutrition Facts label regulation will help ensure that we provide the food industry with guidance to help them modernize their Nutrition Facts labels and that industry has sufficient time to complete and print updated Nutrition Facts labels,” FDA Commissioner Scott Gottlieb, M.D., said in a statement. “It’s crucial that we provide clear expectations so that industry can meet them.”

FDA noted its rule—requiring updates to the Nutrition Facts label—reflects modern science, including the correlation between diet and such chronic diseases as obesity and heart disease. The revised label will make it easier for consumers to make informed choices about the food they eat, according to the public health agency.

In a news release, FDA said it published “the Serving Size final rule to update the serving size requirements to more accurately reflect what people actually eat and drink, and set new labeling requirements for certain size packages.”

The sweeping overhaul of the Nutrition Facts label is the first in 20 years and includes a modified list of required nutrients that must be declared on the label, updated serving size requirements, as well as an updated, easy-to-read design.

“Working to improve the nutrition and diet of Americans can be a transformative effort that helps reduce the burden of many chronic diseases, ranging from diabetes to cancer to heart disease,” Gottlieb said in his statement.

In 2014, an FDA official estimated the cost to industry at around $2 billion, although he said the regulations are projected to yield $20 billion to $30 billion in economic benefits.

According to a national poll conducted by the Center for Science in the Public Interest (CSPI), 87 percent of Americans maintain label updates are useful to them. Already, the new labels have appeared on 29,000 products, Peter Lurie, M.D., president of the consumer watchdog group, said.

FDA’s announcement to grant the extension “should be a call to action for companies to provide consumers the information they want now,” Lurie said in a statement, “rather than waiting for the legal deadline.”

A food and beverage trade group was pleased with the recent extensions granted by FDA.

“We welcome this action by the FDA to provide companies with additional time to execute these updates to the Nutrition Facts panel in a manner that will help reduce consumer confusion and costs in the marketplace,” said Pamela G. Bailey, president and CEO of the Grocery Manufacturers Association (GMA), in a statement. “Food and beverage manufacturers are committed to giving consumers the information and tools they need to make informed choices, and these updates to the Nutrition Facts panel are an important part of that ongoing commitment.”

UNPA Signs MOU With Three Trade Associations and the Trust Transparency Center

The United Natural Products Alliance (UNPA) signed memoranda of understanding (MOU) agreements with three single-ingredient trade associations, as well as with the Trust Transparency Center (TTC), which serves as the administrative umbrella for the associations.

The agreements, signed with the Global Curcumin Association, the Global Prebiotic Association and the Vitamin K2 Association, are designed to help advance consumer confidence, industry standards and compliance with federal laws and regulations governing natural product ingredients and dietary supplements. The new agreements join previous MOUs UNPA has in place with the CoQ10 Association and the Natural Algae Astaxanthin Association, also administered by TTC.

“UNPA supports the mission of TTC and these new organizations, and is pleased to expand our partnership agreements to include the TTC team,” said Loren Israelsen, UNPA president, in a statement. “It is through collaboration and the sharing of resources that the supplement industry will be able to further standards and science to ensure that consumers have broad access to natural health products of superior quality, benefit, reliability and sustainability.”

The Trust Transparency Center operates as the directorate and incubator of several single-ingredient trade associations, including the CoQ10 Association, Global Curcumin Association, Global Prebiotics Association, Natural Algae Astaxanthin Association and the Vitamin K2 Association. It strives to equip its partners with understanding of the global supply chain and to combine trust with transparency to improve culture, values, relationships and customer confidence in the supplements and natural products industry.

Director of NIH’s Office of Dietary Supplements Retiring

Paul M. Coates, Ph.D., is retiring as the director of the Office of Dietary Supplements (ODS) within the National Institutes of Health (NIH).

Coates, who has served as the director of ODS since 1999, described his 19-year tenure as “exciting and gratifying” in a statement on ODS’s website announcing his retirement, effective June 22, 2018.

“ODS has grown substantially in size, in budget and in impact over the years, and it’s been a privilege to be part of that growth,” Coates said. “All of the impact that we have had can be directly attributed to the work that ODS staff have accomplished—along with their colleagues in government, as well as in the private and academic sectors. I owe them a debt of gratitude for their willingness to include me in their remarkable efforts.”

Upon Coates’ retirement, Joseph Betz, Ph.D., will serve as acting director of ODS. Betz joined ODS in 2002 as its first director of the Analytical Methods and Reference Materials (AMRM) program. He also worked at the American Herbal Products Association (AHPA) and FDA, where he was a research chemist for more than a decade.

Coates first served as director of ODS in 1999, five years after passage of the Dietary Supplement Health and Education Act (DSHEA) of 1994, which authorized the creation of ODS. According to ODS’s website, its mission “is to strengthen knowledge and understanding of dietary supplements by evaluating scientific information, stimulating and supporting research, disseminating research results, and educating the public to foster an enhanced quality of life and health for the U.S. population.”

In fiscal year 2016, ODS had a budget of $25.3 million, which predominantly supports research projects.

Fruit d’Or Partnership Brings Cranberry Benefits to Personal Care, Cosmetics

Fruit d’Or and RSSI entered into a memorandum of understanding (MOU) with biotechnology company Hydromer Inc. to create patented antimicrobial/antioxidant personal care and cosmetic products using Fruit d’Or’s organic Cran Naturelle Oil cranberry seed oil.

This MOU capitalizes on newly discovered synergies between Cran Naturelle Oil and Hydromer’s patented botanical carvacrol technology—a blend of natural ingredients derived from oregano, lecithin and xanthan gum—to develop cranberry products for the nutraceutical, cosmetic and personal care industry.

“Cranberry oil as an antioxidant, combined with the carvacrol technology, will be a game changer for our nutraceutical world as it will be an all-natural barrier to fight against bacteria, viruses and fungi,” said Stephen Lukawski, partner of Fruit d’Or and CEO of RSSI.

According to Hydromer’s Eric Becktel, co-inventor of the carvacrol technology, Cran Naturelle Oil in combination with the carvacrol technology significantly increased the microbial kill rate of the ingredient to 100 percent when tested against common pathogens including S. aureus and pathogenic E. coli, as well as Pseudomonas, a urinary tract infection (UTI)-causing bacteria that is particularly resistant to other antibacterial products.

The companies will preview collaborative prototypes at IFT18 Annual Meeting & Food Expo in Chicago, July 15-18, and at VitaFoods Europe in Geneva, Switzerland, May 15-17.

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