The Heat Is On - Just Don't Get Burned!

Summer is definitely here and most likely you have already made at least one trip to the store to purchase sunscreen. On your trip you may have found yourself a little overwhelmed by the variety of sunscreens available – waterproof, water resistant, sweatproof, broad spectrum, sun protection factors (SPFs) from 8 to 75+, sprays, lotions, gels, sticks, towelettes. Well the Food and Drug Administration (“FDA”) is trying to help consumers make more informed choices when it comes to sunscreens.  On June 14, the FDA published new rules and corresponding guidance regarding over the counter (OTC) sunscreen labeling and testing (collectively the “New Rules”). The New Rules, which are designed to give consumers more information on which sunscreen products offer the greatest protection, go into effect June 18, 2012, and govern how sunscreen is marketed. The prior sunscreen rules focused primarily on protection against ultraviolet B (“UVB”) radiation from the sun (these are the rays that cause sunburns), but did not address ultraviolet A (“UVA”) radiation, which can cause premature aging and skin cancer.  The key provisions of the New Rules include the following:

  • “Broad Spectrum” designation: Sunscreens that pass the FDA’s “broad spectrum” test procedure, which measures UVA protection relative to its UVB protection, may be labeled as “Broad Spectrum SPF [value]” on the front label. To pass the broad spectrum test, which is outlined in 21 CFR 201.327(j), the amount of UVA protection must increase as the SPF value increases. The New Rules also modify the existing SPF test.
  • Use claims: Only Broad Spectrum sunscreens with an SPF value of 15 or higher can claim additional benefits – such as, reduces the risk of skin cancer and early aging if used as directed with other sun protection measures (such as limiting time in the sun and wearing protective clothing). Non-Broad Spectrum and Broad Spectrum sunscreens with an SPF of between 2 and 14 may only claim to help prevent sunburn and must include the warning “Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging."
  • Prohibition of “waterproof,” “sweatproof” and “sunblock” claims: These claims are prohibited because the FDA’s research showed that such claims overstate effectiveness. Sunscreens also cannot claim to provide sun protection for more than two hours without reapplication or to provide protection immediately after application, without submitting data to the FDA and obtaining approval.
  • Water Resistance claims: The New Rules establish testing for water resistance and require manufacturers to indicate on the front label whether the sunscreen remains effective for up to 40 minutes or 80 minutes while swimming or sweating, based on standard testing. Sunscreens that are not water resistant must include a direction instructing consumers to use a water resistant sunscreen if swimming or sweating. 
  • Drug Facts: All sunscreen must include standard drug facts on the back or side of the container. 

In addition to the New Rules, the FDA published a proposed rule (“Proposed Rule”), an Advanced Notice of Proposed Rulemaking (“ANPR”) and guidance for the industry (the “Guidance”). The Propose Rule, if finalized, would limit the maximum SPF value to “50+” because the FDA has not seen sufficient data to show that products with SPF over 50 provide greater protection. The Proposed Rule is available for public comment until September 15, 2011. 

The ANPR requests additional data relating to sunscreen products in specific dosage forms (such as oils, creams, sprays, sticks, gels, butters, etc.) to further the understanding of how dosage forms affect safety and effectiveness.

The Guidelines set forth the FDA’s proposed enforcement policy for the OTC drug products marketed without an approved application. These guidelines are open for comment until mid-August.

Why is this important?  The FDA announced its intent to draft sunscreen rules in 1978 and published rules in 1999.  The agency then put the implementation of the 1999 rules on indefinite hold until it could address both UVB and UVA radiation. Then in 2007, the agency published a proposed rule that addressed SPF testing and labeling, but still did not lift the stay on the 1999 rule. Although many sunscreen manufacturers may already follow the proposed guidelines set forth in 2007, it is doubtful that implementation of the New Rules will be delayed – thus compliance will be required. The good news is that sunscreen manufacturers now have clearer guidance on testing. The bad news is that costs will be associated with compliance, including new testing and relabeling products. To ease the economic burden, the compliance date for all products with annual sales of less than $25,000 is June 13, 2013. For all other OTC sunscreen drug products without an approved application, the compliance date is June 18, 2012.

New gTLD Plan Approved by ICANN; Now is the Time to be Asking -- How Valuable is my Name?

We have written quite extensively over the last several months about the developments brewing within the International Corporation for Assigned Names and Numbers to change the current domain name system. In short, companies and organizations located anywhere in the world will soon be able to register and operate a gTLD that corresponds to just about any any word or phrase (including a company's / organization's own name), and use that as the top level domain without the traditional extensions of .com, .net, .org, etc. The following Client Alert discusses this important development in greater detail.

Facebook Gets In Your Face

This post was written by Spencer Wein.

Facebook has rolled out a new feature that uses photo recognition technology to suggest friends’ names to tag in uploaded photos. While certainly an impressive feature, the problem is that the social network giant introduced the feature as a default setting rather than as an opt-in option. This has left privacy advocates up in arms. 

Prior to facial recognition technology, Facebook users could manually tag pictures without permission from their friends. Under the new default settings, when a Facebook user adds photos to his or her pages, facial recognition software suggests names of people in the photos to tag based on pictures in which that user’s friends have already been identified. The feature is active by default on existing users’ accounts, though Facebook does explain on its blog how users can disable the function if they don’t want their names to be automatically suggested in their friends’ photographs.

On June 10, Washington-based Electronic Privacy Information Center (“EPIC”) filed a complaint with the Federal Trade Commission regarding Facebook’s new automated tagging feature. EPIC uses strong, Orwellian language, alleging that “[u]sers could not reasonably have known that Facebook would use their photos to build a biometric database in order to implement a facial recognition technology under the control of Facebook.” EPIC further warns that “absent injunctive relief by the Commission, Facebook will likely expand the use of the facial recognition database it has covertly established for purposes over which Facebook users will be able to exercise no meaningful control.” In its request for relief, EPIC urges the FTC to force Facebook to suspend photo-recognition “pending a full investigation, the establishment of stronger privacy standards and a requirement that automated identification, based on user photos, require opt-in consent.”

Facebook, on the other hand, has downplayed the recent complaints, writing on its blog that “Tag Suggestions” had already been widely available in most countries as it had been phased in over several months. “We launched Tag Suggestions to help people add tags of their friends in photos; something that’s currently done more than 100 million times a day,” Facebook further noted in an emailed statement. “Tag suggestions are only made to people when they add new photos to the site, and only friends are suggested.”

By limiting the feature to a user’s friend list, Facebook has attempted to minimize privacy infringement. However, there is no guarantee that Facebook does not eventually extend the tag suggestions to its complete user base. A person could conceivably take a picture in a public place, and then easily learn a stranger’s identity. At worst, this could help facilitate criminal acts. At a minimum, the technology could create online reputation problems. 

Additionally, it is unclear if Facebook will make the technology available to advertisers. Though certainly not an imminent danger, it is possible that the technology will reach a point where advertisers will recognize people in physical spaces and present personally tailored ads. Further, we cannot know how Facebook will respond to subpoenas and government requests for such data. 

Regardless of the technology’s “Big Brother” potential as well as the ongoing backlash that Facebook seemingly continues to experience with the rollout of each new feature and tool, it's quite surprising this company maintains the same, standard modus operandi of making its privacy-related features and tools the "default" setting. It will be both important and interesting to monitor how Facebook and its opponents handle this latest privacy issue.

Facebook's Newest Revision to its Promotional Terms of Use

This post was written by John P. Feldman and Drew R. Boortz.

Facebook revised its promotion rules for sweepstakes and contests on the premier social networking site. These revised terms went into effect May 11, 2011.

Communication About a Promotion Still OK

Although the revised promotion guidelines define “communication” broadly, they do not add any new restrictions in this regard. Thus, as it was before, one may advertise on Facebook for a promotion that exists outside of Facebook. 

Clarifications Regarding Administration of Promotions

The real meat of the revision is in Facebook’s clarification that one cannot use Facebook functionality to administer a promotion, including the entry process, voting, or communication, with potential winners.

  • All promotions administered on Facebook must be accomplished through an application. This is not a new requirement, but it was not always clear when and where that application must reside. Now, Facebook states that all promotions must be administered within Apps on Facebook.com, either on a Canvas Page or an app on a Page Tab. 
  • As before, all promotions on Facebook must include the following:
    • A complete release of Facebook by each entrant or participant.
    • Acknowledgment that the promotion is in no way sponsored, endorsed or administered by, or associated with, Facebook.
      • These were generally required under the older guidelines but seemed to apply even when a promotion was simply communicated on Facebook. Now, it’s more clear that they apply when you are administering a promotion on Facebook
      • Plus, there is now an additional required disclosure: Disclosure that the participant is providing information to [disclose recipient(s) of information] and not to Facebook.
      • Also, Facebook has underscored its desire to distance itself from any third-party promotion by prohibiting promoters from using Facebook’s name, trademarks, trade names, copyrights, or any other intellectual property in connection with a promotion, or to mention Facebook in the rules or materials relating to the promotion.
        • This obviously creates a tension – how can a promotion-sponsor tell consumers how to participate in a promotion run on Facebook without using the word “Facebook”?
        • Furthermore, Facebook is generally liberal with third-party use of certain IP (e.g., the “Like” functionality), so this provision seems at odds with how Facebook typically operates.
        • This provision is likely to be enforced when a promotion sponsor borrows “too much” of Facebook’s IP, and makes Facebook appear to be a promotion participant or sponsor. 
  • Facebook has now restricted the use of standard Facebook features as a method of registration or entry into a promotion. The new guidelines state: “One may not use Facebook features or functionality as a promotion’s only registration or entry mechanism. For example, the act of liking a Page or checking in to a Place cannot automatically register or enter a promotion participant.” Although this provision could be interpreted as prohibiting the use of “liking” or “checking in” for any promotion, we do not think this is Facebook’s intent. Rather, when this provision is read in context with the following provision, we think it more likely that Facebook means that the use of standard Facebook functionality cannot be the only method used for entry or registration; entry or registration must still utilize an application.
    • This could mean that a promotion sponsor cannot do a simple “fan” giveaway where it distributes prizes to one or more of its “fans.” A promotion such as this would involve selection of winners from among individuals who merely utilized Facebook functionality (i.e., “Liking”). Because it does not utilize an application, the promotion would be prohibited under the Facebook guidelines.
  • The next provision states: “You must not condition registration or entry upon the user taking any action using any Facebook features or functionality other than liking a Page, checking in to a Place, or connecting to your app.  For example, you must not condition registration or entry upon the user liking a Wall post, or commenting or uploading a photo on a Wall.” This prohibition essentially says that to the extent you have built an application to administer your promotion, you can require that people download your application, Like your Page, or check into a Place as part of the entry process. But, you cannot require any other action that implicates other Facebook features or functionality, such as liking a Wall post or commenting on a photo on a Wall. 
    • Perhaps the reasoning for this stems from spamming concerns. For example, a promotion entry mechanism that requires someone to post to a Wall would typically get a post devoid of useful content (e.g., “register me,” or “entry”). 
    • This provision should not be interpreted as banning the use of photo upload contests on Facebook. The application built to administer a Facebook-based promotion should include a photo upload element; the promotion should not utilize the standard Facebook “upload to wall” functionality.
  • Facebook has added a new prohibition on the use of “Liking” as a voting mechanism. “You must not use Facebook features or functionality, such as the Like button, as a voting mechanism for a promotion.” This is perhaps the most dramatic change in the revised promotion guidelines as many promotions used “Liking” as a proxy for voting. Now, the application built to administer the promotion must include a mechanism for voting that is different from the “Liking” feature. 
    • One interesting question that is not addressed by these guidelines is the use of the “Like” functionality outside of the Facebook network. The “Like” functionality has been distributed throughout the Internet and can appear on a variety of websites not controlled by Facebook. Thus, it is possible that a promotion sponsor could build a microsite to host video uploads and allow viewers to “Like” the videos. Facebook’s system would tabulate the number of “Likes,” effectively transforming them into “votes,” but arguably would not be able to enforce these promotion guidelines as the promotion was not being run “on Facebook.”
  • Finally, Facebook clarified the old prohibition on the use of Facebook messaging systems (e.g., messages, chat, wall posts, etc.) to notify winners: “You must not notify winners through Facebook, such as through Facebook messages, chat, or posts on profiles or Pages.” This further separates Facebook from any implication of sponsorship, and means that a sponsor must be sure to obtain entrants’ contact information so that it may contact them outside of Facebook.

What We're Reading 6-17-11

What We're Reading

MediaPost:  MIT: Personalized Ads Don't Always Work 

Personalized advertising isn't all it's been cracked up to be, according to a new study from MIT.
Contrary to popular practice, personalized ads not only don't drive conversions, but are likely to be ignored, according to the study by MIT Sloan School of Management Prof. Catherine Tucker and London Business School Prof. Anja Lambrecht.

 

Reuters:  Google has no agreement yet to digitize books

Google Inc has yet to agree with authors and publishers on a legal plan to create the world's largest digital library, and a federal judge who struck down an earlier accord gave it another seven weeks to try.

 

eMarketer:  Display Ads Lift Branding Metrics

Rich media campaigns boost intent to recommend

Display campaigns may not often get credited with the last click before a conversion, but their value as a branding tool continues to be borne out. Research from audience data intelligence firm Lotame indicates a significant lift in intent to recommend a product among internet users who have seen a display ad.

 

ClickZ:  Behavioral Icon Appears in Political Ads

The online ad industry's self-regulatory program is getting political. Online ads from political advertisers have begun featuring the Ad Choices icon, which notifies users that an ad has been targeted through behavioral data.

 

paidContent:  Twitter And Facebook Reminders Banned From French Airwaves

How do you say Facebook and Twitter in French? You don’t – at least, not if you are on radio or television, where French officials have banned any mention of them unless they are specifically part of the story.

What We're Reading 6-6-11

What We're Reading

Twitter Gives Users More Privacy Controls for Third-Party Applications

Twitter Inc., the micro-blogging service, added tools that give users more control over how data is shared with third-party applications.

 

FDA seeks tobacco industry input, but some firms frustrated with process

Some tobacco industry representatives expressed frustration Monday with how the U.S. Food and Drug Administration has handled its regulatory authority over tobacco products so far.

 

FTC To Update Online Advertising Guides

The Federal Trade Commission will revamp its 11-year-old online advertising guides to address social media, mobile devices and other newer platforms, the commission announced on Thursday.

 

Social networking privacy bill stalls in Senate

Sen. Ellen Corbett isn't expecting a friend request anytime soon from Facebook CEO Mark Zuckerberg.  The social networking giant is among those working to scuttle Corbett's Senate Bill 242, which is intended to give social network users more control over their online private information.

 

FDA issues warnings to online retailers making 'unsubstantiated claims' about tobacco products

The Food and Drug Administration sent 11 warning letters last week to online retailers selling tobacco products that claimed to reduce the harm and risk of tobacco-related disease.

 

Food makers resist lawmakers’ proposal for guidelines in marketing to children

The food and advertising industries are pushing back against an Obama administration proposal that calls for food makers to voluntarily limit the way they market sugary cereals, salty snacks and other foods to children and teens.

FTC Dot Com Disclosures -- Really?

Many people are unaware the Federal Trade Commission issued a set of guidelines regarding advertising on the web several years ago, known as the "Dot-Com Disclosures". Well, the FTC has decided to revisit these guidelines to determine their applicability with the rapidly changing digital landscapes, and to seek comments from the general public as to what still works and what needs to be fixed. Please enjoy this client alert that details the FTC's efforts in this endeavor.