OverTheCounterToday

This Week In OTCs And Nutritionals: FDA Hears Concerns About Allowing Novel Switches

Health care industry experts' comments to FDA show that clearing alternative routes to nonprescription status will encounter bumps and generate concerns, as you’ll read in the April 2 issue of “The Tan Sheet.”

At a public hearing on ideas about making more drugs available nonprescription but “under conditions of safe use,” stakeholders questioned whether some prescription "antidotes" should be switched to restricted nonprescription status, and noted that  drug firms likely will not invest in novel switches without market exclusivity and a requirement to make generics also subject to consumer access restrictions. 

In this issue we also report on the Health Choices Coalition urging Congress to support legislation that would strike the health care reform law requirement that consumers obtain a prescription in order to purchase OTCs with a pre-tax savings account.

For much more, and "The Tan Sheet's" April 2 table of contents, click here.

"The Tan Sheet" is your source for the most comprehensive and in-depth coverage of the OTC drug and nutritional industries. Start your free trial subscription here -- no credit card required.Your company or organization may already provide access to "The Tan Sheet." To find out if you should have access, email custcare@elsevier.com.

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-- Malcolm Spicer (m.spicer@elsevier.com)

 

 

This Week In OTCs And Nutritionals: NDI Guidance Could Be Summer Blockbuster

Just when the supplement industry thought it was safe to go back in the new dietary ingredient water, FDA's top supplement official says more enforcement activity is likely once the NDI notification guidance hits theaters -- er, dockets -- as is expected next week.

But will the guidance prove a smashing success with the industry that has waited years for it? Or will it bomb? This week's issue of "The Tan Sheet" has the story.

Our June 27 edition also shines a light on what FDA thinks about spray sunscreens and checks in with several ingredient companies making moves in the functional foods arena.

 

["The Tan Sheet" is rated "E" for essential market insight covering the OTC pharma and nutritional industries. Snap up a free 30-day trial subscription here.]

 

TOP STORIES

Low NDI Notice Compliance Sets Stage For Enforcement – FDA’s Fabricant
The volume of noncompliant supplement ingredients on the market likely will prompt an uptick in enforcement after FDA releases its NDI notification guidance, which will draw attention to the problem, dietary supplement program chief Daniel Fabricant says.

FDA Questions Spray Sunscreen Safety, Efficacy And Monograph Status
FDA could exclude increasingly popular spray sunscreens from the final monograph unless firms submit sufficient safety and efficacy data, according to an advanced notice of proposed rulemaking.

Ingredient Supplier Interest In Functional Foods Shows No Sign Of Let-Up
Market research firm Mintel says the consumer market for functional foods and beverages has hit a lull, but at the product development level the segment continues expanding with new ingredients and applications.  

FDA Strengthens Sunscreen Testing And Label Requirements

The following story runs compliments of Elsevier Business Intelligence's Health News Daily, your everyday source for the most comprehensive news and analysis covering the pharmaceutical, medical device and consumer health product industries. 

For continuing coverage of FDA's sunscreen regulations, as well as a comprehensive archive of stories addressing this issue, check out "The Tan Sheet" and "The Rose Sheet". Find more information about these and other EBI publications here.

 

FDA Strengthens Sunscreen Testing And Label Requirements

As early as June 2012, labeling for sunscreens that fail comprehensive "broad spectrum" tests or have an SPF less than 15 must include warnings that they have not been shown to prevent cancer or early skin aging, according to an FDA final rule.

Under the rule announced June 14, firms that want to claim a product decreases the risk of skin cancer or early skin aging caused by the sun must meet broad spectrum tests, which measure protection from both UVA and UVB rays.

The final rule also prohibits claims that FDA says overstate sunscreens' efficacy, such as "waterproof," "sweatproof" and "sunblock," and assertions that the product works instantly or for more than two hours without reapplication.

OTC/Nutritional News Roundup: New Wrinkles Edition

 
Firms develop wrinkle and pimple creams as more adults seeks treatment for acne…Gerber adds a new wrinkle to the infant formula market with the first qualified health claim… South Korea health agency opposes regulatory wrinkle allowing wider access to OTC drugs…

[Keep up with all the new wrinkles in the OTC and nutritionals industries, including the latest products for preventing wrinkles, in "The Tan Sheet." Click here for a free trial.]

Prestige Forges OTC Growth With Blacksmith Deal

Prestige Brands and Blacksmith Brands Holdings strike while the iron's hot, with Prestige agreeing to acquire the OTC startup launched less than a year ago for $190 million.

Blacksmith CEO Peter Mann, a former CEO and co-founder of Prestige, said in an exclusive interview "The Tan Sheet" published in March that it is "a good time to be acquiring businesses."

In the deal announced today, and reported here by Reuters and here by the Wall Street Journal, Prestige picks up OTC brands Luden's throat lozenges, PediaCare children's cough/cold remedies and NasalCrom allergy relief spray as well as the Effegrip denture adhesive and Efferdent denture cleanser lines. Blacksmith acquired those brands from McNeil Consumer Healthcare when Mann, private equity investor Dana Schmaltz and Charlesbank Capital launched the firm in November 2009, as we reported here.

Irvington, N.Y.-based Prestige here outlines the strategy behind acquiring Tarrytown, N.Y.-based Blacksmith. Prestige also noted in its acquisition release today that it is selling its Cutex line of nail polish removers, "the largest remaining product" in its personal care business, to Arch Equity Partners of St. Louis.

("The Tan Sheet" keeps ours irons in all OTC and dietary supplement industry fires top bring you the latest and most comprehensive coverage. Your free trial starts here.)

-- Malcolm Spicer (m.spicer@elsevier.com) 

This Week In OTCs And Supplements: Table Of Contents

  
  
 

In this week's issue of "The Tan Sheet", Perrigo reveals its equivalent of Reckitt Benckiser's Mucinex is out for the count -- or at least for much of the private labeler's fiscal 2011 -- after an appeals court ruled against Perrigo in a patent infringement suit.

Food safety reform is showing signs of a late-round comeback in the Senate, which has been sitting on the legislation since late 2009. Dietary supplement industry stakeholders are bracing for a battle royal once food safety reaches conference committee, given the House bill does not exempt supplement manufacturers from certain provisions.

Also on our Aug. 16 fight card, FDA reminds industry it can deploy a variety of weapons through its current recall authority. Meanwhile, GlaxoSmithKline promotes both fighters in an online ad campaign pitting BC Powder and Goody's pain relievers against each other and letting consumers vote for their favorite. The fight may not be fixed, but the winner will most definitely be GSK.

 

(For more blow-by-blow news and analysis of the OTC and supplement industries, tune in to "The Tan Sheet." Get your first issue free by clicking here.)

 

TOP STORIES

FDA Warns In Recall Guidance Agency Has Arsenal Of Enforcement Options
FDA warns that even though it cannot mandate a drug recall, "it can take more authoritative legal actions" against firms selling defective health products.

Food Safety Legislation Shows Signs Of Life In Senate
Food safety enforcement legislation looks likely to pass in the Senate after Congress returns from its August recess.

Perrigo's Generic Mucinex Becomes A Long Shot To Launch In Fiscal 2011
Perrigo further delays plans for a generic version of Reckitt Benckiser's Mucinex, saying the product it once touted as a 2010 highlight may not emerge even during the firm's fiscal 2011.

This Week In OTCs And Supplements: Table Of Contents

 
 

This week's issue of "The Tan Sheet" looks at industry and regulators filling in gaps. Novartis fills in the gap left by Johnson & Johnson's recalled Children's Tylenol products by opportunistically introducing a Triaminic line extension. Reckitt Benckiser plans a Children's Mucinex product to fill a gap in the product line as it prepares to face generic competition. And FDA plans to fill in gaps in public information with its proposals to increase agency transparency. 

Conversely, FDA doesn't quite fill in the gaps regarding the supplement industry's concerns about Sec. 912 of FDAAA.

Our Aug. 2 also fills in our readers on the latest sales and earnings news from companies including NBTY, Colgate, Sanofi and Merck.

(If you're finding gaps in your OTC pharma and nutritional news, try the in-depth coverage and analysis offered by "The Tan Sheet." Click here to check out a free issue.)

 

TOP STORIES

Novartis Extends Triaminic Into Brand Name Void Left By J&J Tylenol Recall
Novartis expedites a Triaminic line extension to take advantage of the branded product gap left by the recall of Johnson & Johnson's Children's Tylenol liquid OTCs.

More FDA Transparency May Confuse Consumers, Stifle Competition, Industry Says
Some FDA proposals to increase transparency could threaten fair competition, innovation and firms' reputations unless the agency provides disclaimers and cautions consumers about drawing conclusions from the information.

FDA Clear On Supplement Ingredient Petitions, But Still Fuzzy On Sec. 912
FDA says current dietary supplement regulations make clear that citizen petitions can be filed to request approval of ingredients that were studied in clinical trials and were part of unsuccessful investigational new drug applications.

This Week In Cosmetics & Personal Care: Table Of Contents

House's "Safe Cosmetics Act" Seeks End To Industry "Free Reign"
Dubbed the "Safe Cosmetics Act of 2010," a bill introduced last week would dramatically overhaul personal-care regulation, requiring companies that manufacture, package or distribute cosmetics for use in the U.S. to register with FDA and provide the agency with a wealth of information about their product formulations and business practices.

A Risk Worth Taking? Unilever Criticized For Skin-Lightening Facebook App

Unilever's controversial Facebook application supporting the launch of its Vaseline Men UV Whitening Body Lotion could represent a risk that was well worth taking.

 

Ivy Nanoparticles Proposed As Organic Alternative To TiO2 In Sunscreens

Isolated organic nanoparticles from English ivy (Hedera helix) offer performance advantages and a superior safety profile compared with nano-sized titanium dioxide, researchers say.

 

("The Rose Sheet" is your weekly source for the most in-depth coverage and analysis of issues affecting toiletries, fragrances and skin care. Click here for a complimentary issue.)

This Week In OTCs And Supplements: Table Of Contents

There is good news and bad news for the dietary supplement industry in this week's issue of "The Tan Sheet." The good news: More qualified health claims flexibility may be on the horizon. The bad news: FTC likely will ramp up claims enforcement for foods and supplements, industry leaders predict. Also in this issue, we explore the dangers cosmetics firms face transitioning to OTC drugs, and how the J&J recall impacts another firm.

Despite FTC's "Timid" Kellogg Action, Rigorous Claims Enforcement Expected – The Federal Trade Commission's enforcement against advertising claims for Kellogg's Rice Krispies cereal appears relatively soft, but dietary supplement firms should not expect the action signals a less stringent approach by the agency, industry stakeholders say.

Selenium Claim Ruling Forces FDA's Hand, May Clear Path For More QHCs – A court decision obligating FDA to reconsider a slate of qualified health claims for selenium could compel the agency to allow more QHCs for dietary supplements.

Private Label Shoppers Need Reasons To Spend More On National Brands – Consumers who "traded down" to less expensive store brands during the recession may not automatically return to name brands when the economy recovers, according to industry experts.

("The Tan Sheet" is your source for breaking news and in-depth analysis of issues affecting OTC pharmaceuticals and dietary supplements. Click here for a sample issue.)

This Week In OTCs And Supplements: Table Of Contents

In the latest issue of "The Tan Sheet," we explore advertising rules and how two companies -- Johnson & Johnson and Beehive Botanicals -- handle challenges to their marketing. We also discuss Perrigo's marketing victory following a court ruling in the private labeler's favor that supports equivalency claims for store brand products compared to name brand products.

J&J To Appeal Watchdog Group's Decision On Listerine Ad -- Products with warnings on labels to "keep out of reach of children," including Listerine Smart Rinse, are inappropriate to advertise during children's television programming - even if ads target adults, according to a recent decision by the Children's Advertising Review Unit

FDA Stings Beehive Botanicals For Web Links That "Fell Through The Cracks" -- Beehive Botanicals has endured product seizure, a complaint from FDA for making unapproved drug claims and potential damage to its reputation because it did not have a complete handle on its Internet presence

Perrigo Verdict Could Bolster Store Brand Equivalency Claims --  A federal court jury ruled Perrigo did not falsely advertise when it claimed its private label glucosamine and chondroitin supplements are comparable to Rexall Sundown's Osteo Bi-Flex joint care products

("The Tan Sheet" is your source for the latest news and in-depth analysis on the OTC and dietary supplement industries. Click here for a complimentary issue.)