FTC commissioner questions enforcement

Commissioner Maureen Ohlhausen says Federal Trade Commission enforcement against firms that FTC officials allege made unsubstantiated claims for purported “melanoma detection” applications could stifle consumer health product development. FTC litigation against UK firm L Health Ld. and other marketers linked to the devices relies on “an unduly expansive interpretation of advertising claims to justify imposing an inappropriately high substantiation requirement on a relatively safe product,” Ohlhausen said in a dissent she made for each agency action against the firms. She added that “this course of action will inhibit the development of beneficial products and chill the dissemination of useful health information to consumers.” FTC said Aug. 13 that L Health settled charges in connection with the “Mole Detective” apps after advertising the apps online beginning in August 2012 after a separate company, New Consumer Solutions LLC, ceased marketing the products following FTC enforcement.

According to FTC’s complaint filed in federal court in Illinois, the Mole Detective apps instructed users to photograph a mole with a smartphone camera and input other information the apps used to allegedly determine the mole’s melanoma risk to be low, medium or high. The FTC alleged that without substantiation, the firms deceptively claimed the apps accurately analyzed melanoma risk and could assess such risk in early stages. The proposed settlement prohibits L Health from making misleading or unsubstantiated claims about the health benefits or efficacy of any product or service and imposes a judgment of more than $58,000, which is suspended based on the firm’s inability to pay. New Consumer Solutions agreed to a settlement with FTC in May 2015.

Mannatech adds CEO to Bala’s title

[Mannatech Inc.] adds CEO to President Alfredo Bala’s job title a week after the nutritional products direct seller reported $3.1m in net income, or $1.15 per diluted share, for its fiscal 2015 second quarter following a $700,000 loss in the year-ago period. Bala, who joined Mannatech in 2007 and became president in June 2014, replaces Robert Sinnott who was named co-CEO in 2009 after the sudden resignation of the firm’s previous chief executive and became CEO in 2012. Bana’s experience includes 16 years as chief operating officer of Britt Worldwide LLC, one of the largest marketing organizations for home and personal care product direct seller Amway.

The Coppell, Texas-based firm on Aug. 4 reported net sales for the April-June period for 2015 were flat, up 0.9%, at $46.7m, due partly to foreign exchange rates, and were up 7.6% in constant dollars. Operations outside of North America accounted for around 59.7% of its net sales.

Quell wearable pain relief heads for stores

NeuroMetrix Inc. expands availability of its Quell OTC wearable pain relief technology from online sales and health care professionals to mass merchandisers, chain drug stores and other retailers in an agreement with Advantage Consumer Healthcare. The Waltham, Mass., firm on Aug. 10 said Advantage Consumer Healthcare specializes in launching new products into multiple distribution channels and managing the transition of health care products from prescription to OTC. Quell uses a non-invasive nerve stimulation technology and is designed for people with nerve pain, sciatica, osteoarthritis, fibromyalgia and other chronic conditions.

ED drug in ‘Herb Viagra’

R Thomas Marketing LLC, of the Bronx, N.Y., and Trenton, N.J.-firm Just Enhance LLC marketed as dietary supplements products that contain a drug indicated for erectile dysfunction and that make claims for treating the condition, FDA says in a warning letter. FDA officials determined the firms’ products branded “Black Ant,” “Herb Viagra,” “Real Skill” and “Street Overlord” contain sildenafil, according to the July 31 letter posted on the agency’s website Aug. 11. Claims rendering the products unapproved new drugs include “Increased blood flow to genitals” and “it stimulates the parasympathetic nerve providing a prolongation of the erection.”

Cannabis Science test markets in California

Cannabinoid-based drug developer Cannabis Science Inc. releases its products at public and private dispensaries in California in test marketing ahead of large-scale rollouts through an agreement with the Cannabis Science Research Foundation. Releasing the initial products will “get self-medicating patient feedback,” said Raymond Dabney, president, CEO and co-founder of the firm and the foundation, on Aug. 10. Cannabis Science has products to be released for different ailments as self-medicating patients have “unique needs and desires for their personal ailments.” It will release multiple product dosages and delivery methodologies in various jurisdictions as regulations allow. The foundation distribution agreement is required to accommodate Cannabis Science’s focus on drug development.

Totally Hemp Crazy sings trademark news

“Rocky Mountain High” is more than a song to Totally Hemp Crazy Inc. The Dallas firm on Aug. 10 said it received a trademark from the US Patent and Trademark Office for Rocky Mountain High Energy Drink, the first of several applications it filed in an initiative to create a registered national brand. Totally Hemp Crazy says it expects that “Rocky Mountain High … conveys a positive, intellectual and emotional message in people's minds.”

Health Canada authorizes cannabis oil production

Hydropothecary Corp. is the first marijuana producer authorized by Health Canada to produce cannabis oil from medical marijuana, the Quebec firm said Aug. 6. The products will be available following safety testing and authorization to sell from Health Canada, expected within six weeks of the agency inspecting and approving the firm’s cannabis oil for sale. The company offers four dried Time of Day products. Canadian officials in July 8 said the country would allow licensed producers of medical marijuana to produce and sell cannabis oil under new supplementary licenses.

Industry Roundup: FTC, FDA Enforcement, Mannatech CEO, Quell Distribution

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