Industry News Roundup

‘Heal yourself’ claim nicked by FDA; Urban Moonshine’s error of omission; new tech needs old school substantiation; O2 plans big for InboxFitness; Migranade sprouts spray division; ChromaDex cashes in NeutriSci shares; GoodSense sponsors runDisney; Walgreens joins flu tracking crowd; Qualitas algal omega-3 reaches market; Islet cooks cannabidoil in business plan; and Food Advisory Committee candidates sought.

‘Heal yourself’ claim nicked by FDA

Jansen Enterprises LLC, operating as HealthWorksUSA, makes drug claims for products it markets as dietary supplements, including “Heal yourself of any disease” for its Nutra Blast Natural Energy, FDA says. For another of its products, Nutra Complete, the Minnetonka, Minn., firm says, “When confronting an illness, take a capful every hour and ’swish’ it in your mouth for 30 seconds, then swallow it and don’t rinse,” according to FDA’s Nov. 24 warning letter. And because HealthWorksUSA’s products, also including Ionic Silver Water and Nutra Gel, are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions for use cannot be written on labeling so a layperson can use the product drug safely, rendering it misbranded, FDA Office of Regulatory Affairs Minnesota District told the firm.

Urban Moonshine’s error of omission

Urban Moonshine Inc. misbrands its Immune Zoom, Nettle and Milky Oats dietary supplements by omitting nutrition information, including the quantitative amount by weight per serving for each dietary ingredient in a Supplements Facts box, according to Nov. 20 warning letter. FDA’s Office of Regulatory Affairs New England District also advised the Burlington, Vt., firm about good manufacturing practices violations found in a December 2013 inspection (see story p. 11, Supplement GMP Inspections).

New technology needs old school substantiation

Nature's Range Ltd.’s Jointease Patch may be an advanced and unique formulation, but the firm still needs to provide substantiation for its claims, the U.K. Advertising Standards Authority says. A leaflet for the product stated claims including "you can cure your arthritis using new technology now,” and “not only an extremely effective product for arthritis sufferers reducing pain and inflammation, tenderness and stiffness in the joint, preventing future arthritis problems and greatly enhancing mobility and performance; but … they also help people to balance and maintain healthy lifestyle, as well as helping the body overcome stress and fatigue.” The London firm failed to substantively respond to the independent regulatory agency, which ordered a halt to the ad claims. ASA said arthritis treatment “should be conducted under the supervision of a suitably qualified health professional, which would not be the case with a mail order patch.”

O2 plans big for InboxFitness

Entertainment properties firm O2 Media acquires health and fitness online retailer InboxFitness.com, which sells sports nutrition brands including MAN Sports, 360Cut and Axis Labs. “The capital investment will strengthen and expand InboxFitness.com's growth as well as give the e-tailer a launching platform to take their e-commerce business to an even broader level through national television, YouTube, and other broadcast and media platforms,” the Ompano Beach, Fla., firm noted Dec. 3. InboxFitness in less than a year has built a platform of nearly 3,000 unique products from more than 200 different brands.

Migranade sprouts spray division

Migranade Inc. launches a division devoted to developing and marketing a line of homeopathic nasal sprays, beginning with the launch of a nasal spray version of its Migranade Migraine Relief effervescent tablet. The Los Angeles firm on Dec. 2 said the spray, slated for online sales in the first quarter of 2015 before reaching retail chains, “will allow migraine sufferers to have immediate access” to headache relief while away from home, the firm notes. Migranade recently acquired Oasis Health Products to accelerate its formulation, testing and manufacturing of products (Also see "Industry News Roundup" - Pink Sheet, 21 Nov, 2014.).

ChromaDex cashes in NeutriSci shares

Ingredient supplier ChromaDex Corp. receives approximately $750,000 for the NeutriSci International Inc. shares it received in the sale of its BluScience dietary supplement line. In a Dec. 3 release, Irvine, Calif.-based ChromaDex said the shares, in tandem with its recent $5 million in debt financing from Hercules Technology, will help fund its operations through 2015. ChromaDex closed its sale of BluScience in March 2013, noting the deal, reported to be worth $6 million in total, would allow it to hone its focus on sales of its ingredients as well as accelerate the development of its pipeline, which includes the Niagen and Purenergy lines. The firm, which provides ingredients to supplement, food and beverage, cosmetic and pharmaceutical manufacturers, announced it expects to continue generating cash from its 6% royalty agreement on future net sales of BluScience (Also see "In Brief" - Pink Sheet, 4 Mar, 2013.).

GoodSense sponsors runDisney

Perrigo Co. PLC’s GoodSense brand is the 2015 pain reliever sponsor of the runDisney events, which attract more than 160,000 participants to run through Walt Disney Resorts in Florida and Disneyland Resort in California. GoodSense’s acetaminophen pain reliever is one of more than 200 Perrigo products that treat symptoms and support active and healthy lifestyles, the firm said Dec. 2.

Walgreens joins flu tracking crowd

Walgreen Co. launches its Flu Index weekly report providing state- and market-specific information on influenza and helping identify regions where flu cases could be growing. The index ranks markets and states with the highest incidences of the flu and those showing the largest weekly increases, Walgreens says. Intended as a resource for health departments and media as well as to help drive consumer awareness and prevention within communities, the Deerfield, Ill.-based chain developed the Flu Index using weekly retail prescription data for antiviral medications used to treat influenza from its 8,207 U.S. drug store locations. The index each week lists the top 10 states for flu activity, the top 10 markets for flu activity, the largest week-over-week increases by state and the largest increases by market. “There's a growing need for timely information and reliable data sources throughout the flu season,” Walgreens said Dec. 2. Other chains and OTC manufacturers also offer tracking applications with localized information to help drive cough/cold product sales (Also see "Tracker Apps Help Steer Consumers In Cough/Cold Space" - Pink Sheet, 14 Oct, 2013.).

Qualitas algal omega-3 reaches market

Qualitas Health CEO Yuri Shoshan says the firm emerges as a leader in the next-generation of omega-3s with the launch of nutritional products based on its algal omega-3 oil, Almega PL. The Israeli firm on Dec. 2 said over the past 18 months it transitioned from research and development to the commercialization of its vegetarian, eicosapentaenoic acid-rich, polar lipid-structured omega-3 oil as an alternative to fish or krill oils. Marketers using the ingredient include Helen of Troy Ltd. subsidiary Healthy Directions, a direct seller using the brand Almega PL; and Rejuvenation Science Labs, which features a blend of Almega PL, algal and docosahexaenoic acid and astaxanthin in its Veggie Omega-3+ supplement. Other consumer product launches containing Almega PL will roll out in the first half of 2015, says Qualitas, which has a U.S. office in Imperial, Texas.

Islet cooks cannabidoil in business plan

Personal care products marketer Islet Holdings adds the development, production and sales of cannabidiol oil – one of 85 cannabinoids present in the cannabis plant – to its business plan. The Denver firm intends to produce CBDs for wholesale and retail sales and plans to establish strategic alliances and arrangements before the end of 2014. The firm, which markets skin care products under the brands Biozhem and RevitaCel System, said on Dec. 3 it will obtain CBDs from domestically grown hemp plants to further assure its planned and stringent quality controls from planting to packaging. “Many people are suffering today needlessly,” CEO J. Michael Heil said. “We intend to meet their needs through natural and organic products.”

Food Advisory Committee candidates sought

FDA asks for nominations for non-voting industry representatives on the agency’s Food Advisory Committee and for industry organizations to participate in the selection of the representative. A Federal Register notice prepared for Dec. 8 publication says candidates can be self-nominated or nominated by an organization. Organizations interested in participating in the selection should contact FDA by Jan. 7, after which the agency within the following 30 days will submit a list of nominees to all participating organizations and ask them to confer and select a candidate. “The interested organizations are not bound by the list of nominees in selecting a candidate. However, if no individual is selected within 60 days [FDA] will select the nonvoting member to represent industry interests,” according to the notice.

ViSalus spreads internationally

Nutritional and weight loss product direct seller ViSalus Inc.’s expansion reaches Spain in November, completing its international initiative ahead of schedule. The Los Angeles firm launched operations in Ireland in June and the Netherlands, Sweden and Finland in October. In addition to supplement products, ViSalus provides a social media platform for customers to make commitments to weight loss or fitness goals. In the firm’s expansion initiative, co-founders Blake Mallen and Nick Sarnicola hosted meetings in each new market with groups of independent promoters to outline ViSalus’ short- and long-term goals.