Appropriations subcommittee largely ignores FDA

Democrats complain planned cuts to FDA funding could hurt public health, but offered no change to the agency’s proposed fiscal year 2013 appropriation during a mark-up June 6. The House Appropriations Subcommittee on Agriculture, Rural Development, FDA and Related Agencies discussed FDA in opening comments. Rep. Rosa DeLauro, D-Conn., a former chair of the subcommittee, said underfunding FDA would risk Americans’ health. But Rep. Sam Farr, D-Calif., praised an increase in food safety funding and did not mention the proposed cuts among those that went “beyond lean.” FDA would receive $16.3 million less in budget authority, meaning non-user fee funding, in FY 2013 compared to FY 2012. The cut is less than 1%, but also is $44 million less than the FY 2013 funding bill under consideration in the Senate. The House bill would rescind $47.7 million in unobligated balances from prior-year discretionary funds, which a committee staffer said was common practice. Overall, the House bill would give FDA $3.835 billion in treasury and user fee money, while the Senate bill would allocate $3.878 billion.

House passes OTC savings account bill

The Consumer Healthcare Products Association presses the Senate to follow the House’s lead and repeal a provision of the Patient Protection and Affordable Care Act that blocks consumers from paying for OTCs with flexible spending accounts without a prescription. The House of Representatives passed the measure June 7 ([A#05120604007]).

Analysts expect lower Novartis OTC sales

Leerink Swann analysts revise their financial model for Novartis AG, reflecting an expectation of “relatively muted” OTC product sales the rest of 2012. In a June 4 research note, Seamus Fernandez and Swati Kumar project that the manufacturing issues and product recall at Novartis Consumer Health Inc. six months ago will cause company-wide revenue in 2012 to drop 4.1% to $56.28 billion, compared to a previously estimated decline of 2.6%. The analysts further expect flat sales growth in 2013. Novartis has outsourced production of recalled OTCs – which included Excedrin and Bufferin stock-keeping units – but the Swiss company’s remediation of its Lincoln, Neb., OTC facility is taking longer than expected Also see "LIPIL for Moms" - Pink Sheet, 25 October, 2004..

France tightens advertising rules

Advertising for OTCs in France now is subject to a priori restriction, which means firms must apply for a visa GP before marketing, the National Security Agency of medicines and Health Products announced May 31. Under the “new methods of control” for advertising, firms can apply for visa GPs during a one week period every month. The new controls for OTCs are less restrictive than for prescription products, which must apply for an a priori visa PM June 1-15 and Sept. 1 to Oct. 31. Smoking cessation products may seek a less restrictive visa GP because they support a public health goal, the agency says in decree 2012-741.

FDA orders supplements seized at Maine firm

U.S. Marshals visited Global Biotechnologies Inc. May 31 and seized misbranded drugs from the company’s Portland, Maine, facility. Products such as Glucanol, Healthy Trac and Lactopril are labeled as dietary supplements, but FDA said they are promoted to treat diseases, making them illegal drugs and a public health danger. According to Global Biotechnologies’ website, Healthy Trac prebiotic fiber “lowers cholesterol” and Lactopril anti-inflammatory immune system support “helps reduce gastrointestinal inflammation” associated with Crohn’s disease. FDA previously cited the firm for some of the claims in a February 2006 warning letter, but found the firm had not revised the claims.

FDA warns of tainted Reumofan Plus

Reumofan Plus, marketed as a supplement for pain relief, bone cancer and other ailments, contains active drug ingredients that can cause liver injury, weight gain, swelling, cramps and adrenal suppression, FDA warns June 1. The Mexican Ministry of Health ordered the Mexico-based Riger Naturals to recall the product. FDA found in Reumofan Plus the non-steroidal anti-inflammatory diclofenac sodium and the prescription muscle relaxant methocarbamol. Some lots also may contain corticosteroids, FDA adds.

Wellesse maker orders precautionary recall

Botanical Laboratories recalls 313 bottles of Wellesse Digestive 3 in 1 Health liquid supplement in two stock-keeping units after learning an ingredient was potentially contaminated with salmonella. The Ferndale, Wash., company said ingredient supplier Ingredion Inc. found salmonella in one lot of the Purimune prebiotic ingredient used in Wellesse. Botanical Labs’ raw material testing found no salmonella and no illnesses linked to Wellesse have been reported, but the company announced a precautionary recall June 4. The SKUs affected are 16-ounce and 33.8-ounce bottles distributed nationwide after May 1.

Tetley tea claims stir up lawsuit

Marketing claims for the antioxidants in Tetley USA Inc.’s tea products are fraudulent and illegal, according to a lawsuit seeking restitution based on unjust enrichment. Plaintiff Daryl de Keczer seeks class action certification in a May 11 complaint, filed in U.S. District Court for the Northern District of California, San Jose Division. The suit says Tetley’s black, green and iced teas are misbranded based on their nutrient content claims – including “an excellent source of natural antioxidants” – and improper health claims regarding antioxidants’ immune system benefits. Tetley, a New Jersey-based subsidiary of Indian conglomerate Tata Global Beverages Ltd., violates FDA and California law, de Keczer says. The complaint references a 2010 FDA warning letter to Unilever PLC, maker of rival tea brand Lipton, that cited similar antioxidant claims out of compliance with nutrient content claim requirements Also see "Antioxidant Claims Pique FTC Interest As Potential Enforcement Target" - Pink Sheet, 16 May, 2011..

CRN brings Lunada claims to NAD

The National Advertising Division takes issue with several claims and testimonials in marketing for Lunada Biomedical Inc.’s Amberen supplement for menopausal women. NAD’s May 24 review, spurred by a Council for Responsible Nutrition challenge, found the Los Angeles firm supports claims that Amberen can help “rejuvenate mitochondria and rebalance hormone levels.” However, Lunada’s evidence – comprising a mouse study, several un-translated Russian studies and what CRN calls a “highly conflicted clinical trial” –inadequately supported claims that Amberen helps users “suddenly” feel younger with effects that last up to three months, said NAD, part of the Council of Better Business Bureaus. Lunada argued that most of the claims CRN challenged already were “cleared” by another CBBB unit, the Electronic Retailing Self-Regulation Program, in 2010 Also see "National Advertising Division In Brief" - Pink Sheet, 19 April, 2010.. NAD said the ERSP review does not preclude its review. Lunada voluntarily discontinued many claims, but disagreed with NAD’s recommendation to drop a claim that Amberen relieves night sweats.

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