In Brief

Committee demands final sunscreen rule

The House Appropriations Committee, in a report included with the Agriculture/FDA appropriations bill it passed May 31, instructs the agency to issue a final sunscreen rule by Dec. 31. An agency official said FDA likely will publish the final rule this year . The committee’s bill cuts FDA’s fiscal 2012 appropriation for from the federal treasury, but increases user fees (Also see "House FDA Budget Bill Boosts User Fees, Trims Direct Appropriations" - Pink Sheet, 30 May, 2011.). The committee also restored some funding to the Women, Infants and Children program, which provides federal funding for infant formula, among other products. But total funding for the program still would be lower than the current fiscal year.

EU adopts falsified medicines directive

The Council of the European Union hopes to stem the rise of falsified medicines in the EU by adopting May 27 the Directive on Falsified Medicines. The directive requires the addition of an "authenticity feature," such as a barcode, to the outer packaging of products, tighter manufacturing plant inspections and record-keeping requirements for wholesale distributors, new inspection rules and requirements that firms report suspicion of falsified medicines. The measure mostly applies to prescription drugs, and was passed unanimously with one abstention. Latvia abstained because it disagreed with a provision that could extend the requirements to OTC drugs on a case-by-case basis, according to the Association of the European Self-Medication Industry. AESGP says in a same day release that it "appreciates" the adoption, and stresses that nonprescription drugs should remain, in principle, exempt from the obligation to bear safety features.

Gerber touts qualified infant formula claim

The Nestle subsidiary receives the first FDA-approved qualified health claim for an infant formula – linking use of Gerber Good Start whey protein formula with a reduced risk of developing atopic dermatitis. Gerber Products May 26 publicized the claim, which includes FDA language stating "little scientific evidence" indicates a relationship between whey protein formulas and atopic dermatitis. The Florham Park, N.J., company declined to comment on how it plans to use the claim in marketing. FDA rejected Nestle Infant Nutrition's original 2005 petition seeking a broader food allergy QHC for whey protein formula ("Gerber reboots whey protein formula petition," "The Tan Sheet" Aug. 3, 2009, In Brief).

Vitacost fixes organizational, IPO woes

The Boca Raton, Fla., online supplement retailer settles lawsuits related to irregularities in its initial public offering. Vitacost.com had considered bankruptcy after the irregularities came to light late last year ( (Also see "In Brief" - Pink Sheet, 13 Dec, 2010.), In Brief). Also, the firm announced May 31 it will hold a shareholder meeting in September to "take certain actions to ensure that any potential defects in the company's organizational documents are unquestionably cured."

Ashland acquires ISP for $3.2 billion

Ashland Inc. expands into the "high-growth" personal care, pharmaceutical and energy markets with the $3.2 billion acquisition of International Specialty Products. The acquisition of specialty chemical manufacturer ISP also strengthens Ashland's functional ingredients active patent portfolio and research and development department, Ashland announced May 31. The combined functional ingredients business will contribute roughly half of Ashland's $1.1 billion pro forma EBITDA. Before the deal, Ashland generated sales of about $7.6 billion in the year ending March 31, 2011. During that same period, ISP generated sales of about $1.6 billion. Ashland expects cost savings from the deal of about $50 million within two years of the closing, which is expected by the end of September.

White Coat Nutrition takes new approach

The Salt Lake City company eschews expensive "high-touch distribution" in favor of launching online sales of its dietary supplements so that its "customers won't have to sign up for a part-time job just to buy our supplements," White Coat Nutrition says in a June 2 release. It explains that network marketing is an effective distribution channel for natural products but "customers pay for that high-touch service." By moving online, White Coat can offer its GMP-compliant products for less. Its products include a children's multivitamin, a glucosamine supplement to support joint health and a probiotic formula, among others.