In Brief

Imidazoline childproof package deadline extended; FDA wants to define food allergen thresholds; Danone cuts workforce in Europe; Primatene Mist bill voted down in the house; CARU urges WhoNu? ad off kids TV; Bayer recalls Bronkaid; Tate & Lyle to develop Nandi Proteins food ingredient; more news In Brief.

Imidazoline childproof package deadline extended

The Consumer Product Safety Commission cedes to the Consumer Healthcare Products Association’s request for more time to create childproof packaging for eye drops, nasal decongestants and other products that include 0.08 mg or more of imidazoline per package. CPSC says in a final rule published Dec. 10 that it will give drug makers an additional year beyond the Dec. 10, 2013, compliance date to create childproof packaging for affected imidazoline products as long as firms notify the commission of their plans to avail themselves of the enforcement stay prior to the effective date and then update the commission quarterly on their progress toward compliance. CHPA argued that firms needed more than a year to create childproof packaging and to go through FDA’s approval process (Also see "CHPA Requests Extension To Childproof Imidazoline Product Packaging" - Pink Sheet, 16 Apr, 2012.).

FDA wants to define food allergen thresholds

FDA requests help establishing regulatory thresholds for major food allergens so that it can enforce food allergen labeling requirements, according to a Dec. 14 notice in the Federal Register. Specifically, the agency seeks input on how to define an allergic response that poses a risk to humans, identify which allergens are the greatest public health concerns, establish how clinical dose distribution data should be used to establish regulatory thresholds for allergens, use biological markers and other factors to measure the severity of allergic responses in a threshold risk assessment and what information exists about exposure to allergens by people trying to avoid them. Comments are due 60 days from publication.

Danone cuts workforce in Europe

Danone plans to generate $2.6 million in savings in the European market in the next two years by reducing administrative costs and via management re-organization. In a Dec. 13 release, the maker of Activia yogurt said it will do this to “win back competitive edge.” The details about the plan will be submitted by March 2013. In 2011, Danone generated sales of $19.5 billion, of which more than half were in emerging markets.

Primatene Mist bill voted down in house

The Asthma Inhalers Relief Act of 2012 fails a House vote 229-182 on Dec. 12. H.R. 6190 would have allowed Amphastar Pharmaceuticals Inc. to market the remaining 1 million units of OTC asthma inhaler Primatene Mist. FDA ordered the product off the market Dec. 31, 2011, because it contained ozone-depleting chlorofluorocarbons (Also see "Armstrong Juggles Reformulating Primatene Mist, Pushing To Sell Existing Inventory" - Pink Sheet, 23 Jul, 2012.). The inhalers have a two-year shelf life, and the remaining units begin expiring in January 2013. Amphastar must now dispose of the inhalers, which could cost $250,000 to $500,000. A firm spokesman said Amphastar has a pre-new drug application meeting scheduled January 31, 2013, and that it applied for the meeting in July. The firm expects to submit an NDA in the first quarter of 2013 for a CFC-free inhaler. Previously it said it would submit the NDA in the fourth quarter of 2012.

CARU urges WhoNu? ad off kids TV

Suncore Products LLC agrees to cease airing a TV commercial for its WhoNu? nutritionally fortified cookies during programming for viewers younger than 12, in accordance with a recommendation from the Council of Better Business Bureaus’ Children’s Advertising Review Unit. The Denver-based firm was advertising its WhoNu? snacks – with added calcium, fiber, iron and vitamins – during children’s shows on The Hub TV and Nickelodeon networks, touting the cookies’ nutritional equivalencies to oatmeal, milk and whole fruit. Though CBBB’s National Advertising Division previously found the ad did not expressly compare WhoNu? cookies to whole foods, CARU’s decision published Nov. 29 says NAD had considered an adult audience (Also see "National Advertising Division In Brief" - Pink Sheet, 20 Feb, 2012.). In contrast, “a child viewing the commercial could reasonably take away the message that eating a cookie would be just as healthy and nutritious as eating the other foods depicted,” CARU says. Suncore disagreed with CARU’s interpretation of the NAD decision.

Bayer recalls Bronkaid

Bayer HealthCare LLC voluntarily recalls 11 lots of Bronkaid Dual Action Formula 24 coated caplets and 45 lots of Bronkaid Dual Action Formula 60 coated caplets Dec. 7 because the labels lack some warnings. The Morristown, N.J., firm said the recall does not affect the quality of the product, and consumers can use the product as long as they are mindful of the warnings that were excluded. These include to stop use and ask a doctor if asthma worsens, “you have difficulty sleeping,” “you have rapid heartbeat” and “you have tremors, nervousness or a seizure.” Bronkaid is indicated for relief of bronchial congestion and mild intermittent asthma symptoms.

FDA discourages use of two phthalates

FDA advises against the use in OTC and prescription drugs of two phthalates, commonly used as plasticizers in enteric coating, according to a final guidance issued in December. The agency notes dibutyl phthalate and di(2-ethylhexyl) phthalate are endocrine-disruptors that hinder development and reproduction in animal studies. Even though human studies are limited, the agency notes other, safer alternatives are available (Also see "Regulatory News In Brief" - Pink Sheet, 12 Mar, 2012.).