Industry Roundup: USPlabs Cleared In DMAA Suit, AHPA Opposes Blueberry Extract Tariff Hike

MJN product mix change drives growth; mercury, high lead level in skin care products; Green Supreme, Nutri-Dyn Midwest warned; and more consumer health news in brief.

USPlabs, GNC cleared in DMAA suit

A federal judge dismisses all claims against [USPlabs LLC] and GNC Corp. bythe family of a US military member who died during a training exercise while using USPlabs' dimethylamylamine-containing Jack3d because the evidence they presented was unreliable. Citing a report by the Department of Defense in the order overruling the plaintiffs' objections, a judge in the US District Court for the Western Texas District on Jan. 27 said “the evidence does not establish that DMAA-containing products are causally associated with adverse events.” “This victory exonerates USPlabs and proves that these allegations were unfounded,” said lead counsel Bruce Steckler in a Jan. 28 release. In 2013, DoD reported that it could not find a causal link between DMAA and adverse events, particularly the death of four soldiers who took the ingredient, but questioned the ingredient's safety and has maintained a ban on sales of DMAA products at retail stores on military instillations (Also see "Military Report Slams DMAA While GNC Claims Victory" - Pink Sheet, 7 Aug, 2013.).

MJN product mix change drives growth

A favorable change in product mix and better pricing driveMead Johnson Nutrition Co. sales in 2015 for the North America/Europe segment up 1% on a reported basis to $1.28bn, the marketer of Enfamil baby formula said Jan. 28. In the fourth quarter, firm's sales of children's products and European allergy products were strong, but the North American/Europe segment dipped 3% on a reported basis to $329.2m due to a difficult comparison with the year-ago quarter's strong sales, the Glenview, Ill.-based firm said. Sales in China, which represents 48% of its business, slumped 15% in the October-December period to $468m due mostly currency exchange impact. For the year, reported sales in China declined 11% to $2.04bn. The firm's net sales for the year fell 8% to $4.07bn.

Mercury, high lead level in skin care products

State health officials advise FDA about risks of mercury poisoning linked to Crema Piel De Seda skin whitening cream, manufactured in Mexico by Viansilk, and lead poisoning linked to Bentonite Me Baby medicinal clay made by Alikay Naturals. FDA on Jan. 28 said its laboratory analysis identified mercury in Crema Piel after Arizona and Kansas health agency officials reported potential problems with the product labeled in Spanish, sold primarily in Spanish-speaking communities and promoted to whiten skin, treat acne and remove warts and various skin blemishes. Minnesota officials advised the agency about Bentonite Me, which is sold online and in retail outlets with labeling indicating it can be ingested and applied topically to hair and skin for a variety of conditions. FDA laboratory analysis of the product found elevated lead levels.

Green Supreme, Nutri-Dyn Midwest warned

Claims made on websites for Green Supreme Inc., of West Middlesex, Pa., and Nutri-Dyn Midwest Inc., of Maple Plain, Minn., render their dietary supplement products unapproved new drugs, while a Nutri-Dyn facility inspection finds good manufacturing practices problems, according to Jan. 15 FDA warning letters. The warning from the FDA Office of Regulatory Affairs' Philadelphia District to Green Supreme states the firm's drug claims include "Green Supreme with Chromium Picolinate…decreases LDL levels (bad cholesterol), helps to normalize blood sugar, and thus is beneficial for both diabetics and hypoglycemic…reduced heart disease risk, and helping to keep arteries, veins and capillaries clean,” and testimonials on the site include, “ULCERS…My mom told me about Green Supreme. I started taking it – no more ulcer upset…” Additionally, the intended uses indicated by the claims render the products misbranded for failing to provide adequate instructions.

The ORA Minneapolis District warning to Nutri-Dyn identified claims for third-party vendors' supplement and homeopathic products including "Anti-Yeast and Anti-Fungal …proven useful for combating a wide range of viral and bacterial infections,” and “Nutritional Support Against Bacterial, Viral, and Yeast Infections … anti-malarial, antibacterial, anti-fungal, anti-parasitic…activity.” ORA reported finding GMP violations at Nutri-Dyn's facility including failing to establish specifications for identity and purity of finished supplement products it receives from suppliers and to investigate product complaints. The warning also states that products were found labeled with ingredient amounts different from the amounts actually included.

AHPA opposes higher tariff for blueberry extract

The American Herbal Products Association opposes a US Customs and Border Protection's proposal to change the tariff classification of some bilberry and blueberry extract powders. The trade group on Jan. 27 said CBP issued a notice of proposals on Dec. 23 to revoke three ruling letters, modify two and change the tariff classification of the extracts, suggesting higher tariff category because the extracts have been “so enriched or purified so as to fall outside the scope” of their current classification. AHPA says CBP's proposal is directly problematic for bilberry and blueberry extract importers and marketers and presents potential economic burdens on companies that trade in other herbal extracts. “If this particular CBP proposal becomes the norm, we could see inappropriate tariffs applied to many other ingredients derived from botanical extracts.” said AHPA President Michael McGuffin. He added that CBP “should not automatically classify an extract in a higher tariff category based solely on use of processing such as standardization, purification or enrichment with such technologies as column chromatography.”

TINA targets Prevagen memory claim

Truth In Advertising.org advises major TV networks airing commercials for Quincy Bioscience Manufacturing Inc.'s Prevagen supplement aimed at people suffering from memory loss that the organization filed a complaint with the Federal Trade Commission alleging the ads are deceptive. “The company claims that its supplement, which contains a synthetically made protein based on bioluminescent jellyfish, can improve memory in just 90 days without having any competent or reliable scientific evidence to support such a health and treatment claim,” TINA.org said on Jan. 27. The organization in September asked Quincy Bioscienceto change its ad claims and contacted FTC after the Madison, Wis., firm did not respond. TINA.org also sent a letter to the Better Business Bureau asking it to re-evaluate its A+ rating for the company. Quincy Bioscience received an FDA warning letter in 2012 stating that claims and clinical trials for three Prevagen products established them as drugs; the firm corrected those violations (Also see "In Brief" - Pink Sheet, 29 Oct, 2012.).

Bodybuilding.com appoints CEO

Bodybuilding.com, which claims to be the leading online retailer of sports, fitness and nutritional supplements, appoints Richard Jalichandra CEO on Jan. 25. The Boise, Idaho-based firm said Jalichandra previously was CEO of companies including technology provider iSocket and strength training advisor MapMyFitness, and has “extensive digital experience across ecommerce, content, mobile and social.” Jalichandra will target growing the consumer audience for the site, which has 32m monthly visits and offers more than 13,500 health and fitness supplements and accessories, the firm notes.

NEON Energy Drink shines overseas

ViSalus Inc. starts distribution of NEON Energy Drink in Austria, Finland, France, Germany, Hungary Ireland, Italy, the Netherlands, Poland, Spain, Sweden and the UK. The Los Angeles company on Jan. 27 said it launched the product in North America in 2015 and sales have surpassed $5m. ViSalus in 2014 expanded operations, including the sale of supplements, to European countries (Also see "Industry News Roundup" - Pink Sheet, 8 Dec, 2014.).

Recovery Water heads east

Reliant Recovery Water, which delivers electrolytes and modifies water by increasing and stabilizing oxygen levels in water, is available at Whole Foods throughout California, Oregon and Washington and plans to expand eastward in 2016. Tacoma, Wash., marketer Reliant Hydration Inc. on Jan. 27 said the product, promoted as reducing physical stress and accelerating muscle recovery, contains natural ingredients “to keep you hydrated and refreshed” and comes in 500mL bottles for a suggested retail price of $2.99.

Biosphere products on RevNutriition

Biosphere Nutrition, a New Zealand firm specializing in namesake medicinal powdered supplements “easily” absorbed through the body, will be featured on RevNutriation.com. “Our team has expanded significantly in recent months and this placement on RevNutrition.com will grant us a greater ability to reach a larger audience,” Biosphere said on Jan. 28. Biosphere produces powdered supplements in single-serve stick sachets including magnesium and liquid capsule astaxanthin, which the firm notes has been found to reduce the risk of cataracts, improve skin moisture levels, eliminate wrinkles and improve heart health.

UK scientist on EFSA communications

The European Food Safety Authority names Barbara Gallani, currently chief scientist at the UK food industry lobby Food and Drink Federation, to head its Communications and External Relations Department. Appointed following an external selection procedure, Gallani will assume the role May 1 at the Parma, Italy-based agency and will report to EFSA Executive Director Bernhard Url, EFSA said Jan. 25.

Health Delights Naturals debut

Confectionary nutritional products marketer Health Delights announces it is introducing the “second generation” of its products, Healthy Delights Naturals, eight soft chew products available in Vitamin Shoppe stores nationwide. In a Jan. 25 release, the company said the products include appetite control, probiotic coconut oil, biotin, B-12 energy, turmeric, CoQ-10 and prenatal soft chews. The items, which retail at the Vitamin Shoppe for $19.99 for a package of 30 chews, join the company's nutritional chews and bites offerings.

Biopron on Amazon

Czech Republic firm Valosun, which develops and manufactures herbal medicines, probiotics and natural remedies, announces its probiotic complex Biopron supplements – offered in varieties including for seniors and children – are available on Amazon.com. A 60-count probiotic for consumers 50 and up costs $29.87 and Biopron Junior supplements in a 30-count box cost $34.02.