Adlaw By Request : Advertising & Marketing Lawyer & Attorney : Reed Smith Law Firm : AdLaw By Request & KidAdLaw

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.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

Ice Cream maker BEN & JERRY'S confirmed that after receiving a request from the Center for Science in the Public Interest (CSWPI) all BEN & JERRY'S Ice Cream labels will no longer include the phrase "all natural" . The change, according to company spokerpersons, will occur gradually, over time.

The Food & Drug Administration (FDA) itself provides no definition for "natural", a complaint of the CSWPI. The FDA allows use of the term as long as a food product does not contain either artificial flavors or colors, or synthetics. The CPSWPI asked BEN & JERRY'S to remove the term because CSWPI believes the term creates consumer confursion if a product contains alkalized cocoa, corn syrup, hydrogenated oil or other non-natural ingredients.

BEN & JERRY'S spokespersons asserted there would be no change of its ice cream products' ingredients but wants to avoid disputes and possible misperceptions over the term "all natural" which is ambiguous enough to mean different things to various of its customers.

CSWPI called upon the FDA to prepare and issue a formal definition of "natural" for businesses to follow.

BEN & JERRY'S is currently a unit of the consumer product giant Unilever.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

Earlier this month, the Food and Drug Administration (FDA) held public hearings to better understand the role of, and the risks associated with, the promotion and marketing of FDA-regulated products using the Internet and social media. The last such hearing of this kind (which focused solely on the Internet) was organized by the FDA in 1996; and with a very different landscape before them, the FDA felt it was time to invite several of the industries’ players back to D.C. for another chat.

Of key concern to the FDA during the recent hearings were: (1) how can drug companies safely and effectively advertise on the Internet and via social media, and (2) how best can drug information and health side-effects be disclosed and managed in a social media context. This is no surprise, as FDA appears ready to develop a framework through which it will apply product advertising and promotional labeling statutory provisions and regulations to these communications. 

At the outset, both the FDA and its invited speakers, which included representatives from Eli Lilly, sanofi-aventis, Pharmaceutical Research and Manufacturers of America (PhRMA), Pfizer, Google, Yahoo and others, all agreed that the Internet and social media present both new opportunities and unique challenges, as compared with traditional promotional labeling and print, or broadcast advertisements. Today, drug companies have a greater ability to optimize their message and respond more quickly/more effectively to developments in the marketplace. On the other hand, everyone questioned how much control these same companies are expected to exercise over the enormous magnitude of user-generated content that is found across the Internet. As one presenter described the current landscape, “The industry’s share of voice on the Internet – especially the social media part of the Internet – is rapidly being dwarfed.” 

The prevailing view seemed to indicate a willingness and acceptance that drug companies should be responsible and held accountable for any content located on their corporate websites and on third-party sites (Facebook, Twitter, etc.) over which they exert or influence control. These same companies should not, however, be held responsible for content on third-party sites over which they have no control or influence. Along this line of thinking, online pharmaceutical-marketing expert John Mac of Pharma Marketing News, suggested that the FDA take the unprecedented step of requiring that drug manufacturers put “tags” on their Twitter posts in order to monitor and potentially censor discussions about specific products.

Another concern that was raised in the context of user-generated content across the Internet is the reliability and trustworthiness factor of information that is widely available on sites ranging from corporate websites to blogs to Wikis. PhRMA, among others, suggested the creation of an FDA-approved logo or seal of approval that could be affixed to a particular website, link, or even an information set that is presented on a third-party site. The seal would indicate that the FDA has reviewed and approved the information in question.

A focal point for the hearings was the issue of adverse events. Simply put, drug companies have a legal obligation to disclose adverse events that are brought to their attention in certain situations, even after the drug has been approved by the FDA and released to the market. Two specific issues arose on this topic:

• Manufacturers were genuinely reluctant and hesitant to create a presence for themselves within the social media universe in order to avoid learning about potential adverse events associated with their drugs. Although the FDA has established guidelines and steps that must be followed by both consumers and health care professionals to report adverse events, there was still concern expressed that a manufacturer could suffer consequences by ignoring or refusing to investigate adverse events that it learns about through social media.
• Both the speakers and the FDA alike uniformly acknowledged that the medium (i.e., the Internet) and its advertising vehicles (i.e., banners, paid search links, etc.) lend themselves to lesser rather than more disclosures. Hence, these same companies were concerned about how best to present and disclose these potential adverse events and other risks, and avoid running afoul of their reporting requirements, considering so little FDA guidance exists within this area at the current time.  

Thomas Abrams, Director of the FDA’s Division of Drug Marketing, Advertising and Communication, concluded the hearing by acknowledging the FDA has much work to do to further understand and institute guidelines for the promotion of FDA-regulated products on the Internet and social media sites. 

Why This Matters

If Facebook were a country, its user base would make it the fourth-largest country in the world. The number of users participating in some form of social media interaction is increasing at explosive rates day-by-day. Social media has quickly become an environment in which all manner of communication, information sharing and commerce exists. Although drug companies, large and small, are eager to embrace and engage this environment, many have largely avoided using social media out of fear that its use may result in FDA enforcement action. However, the pressure to adopt social media despite this risk continues to increase as competition grows and more consumers adopt these communication tools.

FDA’s social media hearing was a welcome relief to many. It provided industry leaders and stakeholders an opportunity to take an early lead in contributing to the FDA’s emerging policy on Internet advertising and promotional labeling. FDA is accepting public comments until Feb. 28, 2010 on specific questions it posed to the public (FDA Docket No. FDA-2009-N-0441) (74 Fed. Reg. 48083 (September 21, 2009). With the advent of these meetings, and the likelihood that FDA will begin to apply advertising standards to Internet communications in a more consistent manner – and perhaps continue to engage the industry throughout 2010 and beyond – drug companies should begin to think about and act on: (1) any FDA requests for industry input and guidance on social media and industry regulations; and (2) the creation of social media policies and procedures covering everything from employee do’s and don’ts to the management of adverse event information that surfaces through user-generated content. Companies should also be developing strategies to deal with misinformation about their drugs that they become aware of on blogs and Wiki’s. Lastly, companies must continually keep current on positions, approaches and policies taken or instituted by the FDA.

For more information on contemporary legal issues in social media, including many of the points raised above, we encourage you to download our White Paper entitled, “Network Interference: A Legal Guide to the Commercial Risks and Rewards of the Social Media Phenomenon.”

For a detailed analysis of the recommendations and themes raised at FDA’s hearings, please see the Reed Smith Life Sciences Legal Update Blog.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

In what could be a watershed case between a pharmaceutical company and the FDA, Allergan has filed suit against the FDA in the U.S. District Court for the District of Columbia, seeking a ruling from the court that would allow Allergan to share relevant information about the safe use of BOTOX with the medical community for non-FDA approved uses (i.e., off-label uses). Under current law, the FDA restricts its approvals on pharmaceuticals for very specific uses and treatments. Although physicians have quite a bit of maneuverability and flexibility to prescribe drugs for off-label uses, both the FDA and the Justice Department have taken the hard-line position that federal law prohibits pharmaceutical companies from proactively providing information (including advertising) to the medical community regarding off-label uses, even when such information is accurate, complete and beneficial. For the reasons mentioned in the article below, this is particularly problematic for Allergan.

This is a case we'll be following closely on Adlaw by Request, and we'll make every effort to keep you updated on all important developments.The press release is available on Allergen's website.

Read the full complaint (PDF).

• Email This
• Print
• Comments
• Trackbacks
• Share Link

General Mills is the Food and Drug Administration's ("FDA") latest target. In case you think that you misread the previous statement, General Mills—manufacturer of the popular cereal "Cheerios"—received a letter addressed to its Chairman from the FDA May 5 claiming that the FDA has reviewed various Cheerios labels and found they contain "serious violations" of federal regulations. Cheerios is the best-selling cereal brand in the United States, with sales of $1.4 billion last year, according to General Mills.

In recent years, the FDA has begun cracking down on manufacturers who overstate the benefits of their products, amid increased demand for healthy foods. According to the FDA, General Mills is breaking federal regulations on two counts: they are marketing Cheerios like an "unapproved new drug" and misbranding the product by making "unauthorized health claims." What, in particular, has caught the ire of the FDA? The FDA said that the Cheerios product label promotes it like a drug intended for use in the "prevention, mitigation, and treatment of disease." The FDA's letter drew particular attention to phrases that say the product lowers cholesterol by "4 percent in 6 weeks," that it can also reduce bad cholesterol by 4 per cent, and that it is "clinical proven" to lower cholesterol. The letter does not address the veracity of General Mills' claims, but simply the point that by making such claims, the product is being touted and advertised as having the same medicinal effects as other cholesterol-lowering drugs, and therefore should go through the proper channels for obtaining drug approval.

On the positive side, the FDA's letter acknowledges that General Mills had observed regulations correctly in respect of a health claim associating "soluble fiber from whole grain oats with a reduced risk of coronary heart disease," but the two claims about lowering cholesterol go beyond that which constitutes permissible advertising. The FDA said that even if the cholesterol-lowering claim could be argued to be part of an otherwise permissible claim, the wording disqualifies it from use in the soluble fiber health claim.

An important development in this matter is the fact that the FDA cites text on one of General Mills' company websites (www.wholegrainnation.com) as constituting misbranding. According to the federal Food, Drug, and Cosmetic Act (the "Act"), an advertiser's website is considered to be part of the product labeling. The website in question says "heart-healthy diets rich in whole grain foods, can reduce the risk of heart disease." According to the FDA, the claim does not meet the requirements of the Act, which requires such assertions to state that "diets low in saturated fat and cholesterol and high in fiber-containing fruit, vegetable, and grain products may reduce the risk of heart disease." The Cheerios' labeling neither mentions fruits, vegetables and fiber, nor the need for the diet to be low in saturated fat and cholesterol.

The FDA's letter also refers to another labeling claim about reduction in cancer risk. The FDA said Cheerios' claim, which includes the statement "regular consumption of whole grains as part of a low-fat diet reduces the risk for some cancers, especially cancers of the stomach and colon," fails to meet the authorized format because, for example, like the aforementioned claim, it does not mention fruits and vegetables and fiber content, and again denies the public the chance to see the overall context of the healthy diet. The agency has also taken issue with the added phrase "especially cancers of the stomach and colon," which goes beyond what an authorized claim is allowed to say.

In a statement, General Mills spokesman Tom Forsythe defended the cereal's claims. "Cheerios' soluble fiber heart health claim has been FDA-approved for 12 years, and Cheerios' 'lower your cholesterol 4% in 6 weeks' message has been featured on the box for more than 2 years," he said. "The science is not in question. The scientific body of evidence supporting the heart health claim was the basis for FDA's approval of the heart health claim, and the clinical study supporting Cheerios' cholesterol-lowering benefit is very strong. The FDA is interested in how the Cheerios cholesterol-lowering information is presented on the Cheerios package and website. We look forward to discussing this with FDA and to reaching a resolution."

General Mills has been given 15 days to reply with an explanation of how they intend to "correct the violations" and to ensure that "similar violations do not occur." Will the day come when consumers need a prescription to purchase their next box of Cheerios?

• Email This
• Print
• Comments
• Trackbacks
• Share Link

Yahoo! News: Feds sue Dish Network over do not call complaints

The nation's second-largest satellite TV provider — Dish Network — is being sued by the government for alleged violations of the national Do Not Call Registry.

NY Times: 8 Hours a Day Spent on Screens, Study Finds

IN a world with grocery store television screens, digitally delivered movie libraries and cellphone video clips, the average American is exposed to 61 minutes of TV ads and promotions a day.

Adage: Georgia-Pacific Sues P&G for False Advertising by Bounty

Claims that New Paper Towels are Thicker are False, Says Marketer

Brawny paper-towel marketer Georgia-Pacific Corp. is suing Procter & Gamble Co. for falsely advertising "25% thicker quilts" on its Bounty towels.

Reuters: EU threatens action to defend Web users' privacy

Some Internet companies are abusing consumers' personal data and this cannot be allowed to continue, a top European Union official will warn the industry on Tuesday.

Mediaweek: SAG, AFTRA Reach Commercials Contract

SAG and the American Federation of Television and Radio Artists said early Wednesday that they have reached a tentative new three-year commercials contract.

Reuters: House votes to grant FDA authority over tobacco

A measure giving the Food and Drug Administration power to regulate the manufacturing and marketing of cigarettes cleared the U.S. House of Representatives on Thursday.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

Children under the age of 4 should not be given over-the-counter (OTC) cold remedies, according to new labeling being prepared by leading cold medicine manufacturers.

The manufacturers of medicines sold under brands such as Dimetapp, Pediacare, Robitussin, Triaminic and Little Colds have agreed to voluntarily change their labels to state "do not use" for children under 4. In addition, manufacturers of products containing antihistamines will add language to their labels warning parents to refrain from using these medications to induce drowsiness in young children.

The changes came following consultation with the Food and Drug Administration, which earlier this year recommended that children younger than 2 years old should not be given cold medications.

Children's cough and cold medications are safe and effective when used as directed, stressed the Consumer Healthcare Products Association (CHPA), the trade group that announced the voluntary labeling changes. "Research shows that dosing errors and accidental ingestions-not the safety of the ingredients themselves when properly dosed-are the leading causes of rare adverse events in young children," the CHPA stated.

Indeed, a study by the Centers for Disease Control and Prevention, which concluded that thousands of young children are hospitalized annually after ingesting cough and cold medicine, also determined that the vast majority of children hospitalized had taken medication while unsupervised.

Read about the labeling changes at chpa-info.org. 

View news coverage concerning the change at apnews.excite.com. 

• Email This
• Print
• Comments
• Trackbacks
• Share Link

When it comes to the risk posed by bisphenol-A (BPA), the chemical used to make hardened plastic containers such as baby bottles, liners for canned goods, and other plastic items, government officials can't seem to agree.

In September, the National Toxicology Program (NTP), which is part of the National Institutes of Health, released a report concluding that there is "some concern" that exposure to BPA can adversely affect development of the prostate gland and brain, and may cause behavioral effects in fetuses and children.

"There remains considerable uncertainty whether the changes seen in the animal studies are directly applicable to humans, and whether they would result in clear adverse health effects," stated NTP Associate Director John Bucher. "But we have concluded that the possibility that BPA may affect human development cannot be dismissed."

The scarce data leaves consumers in the lurch, conceded Michael Shelby, Director of the NTP's Center for the Evaluation of Risks to Human Reproduction. "Unfortunately it is very difficult to offer advice on how the public should respond to this information," Dr. Shelby stated. "More research is clearly needed ...If parents are concerned, they can make the personal choice to reduce exposures of their infants and children to BPA."

But this summer, the Food and Drug Administration issued findings of its own, and appeared to land on the other side of the fence. The FDA issued a "Draft Assessment" of the use of BPA in food-related products in which it said its data did not support a need to upgrade safety standards: "FDA has concluded that an adequate margin of safety exists for BPA at current levels of exposure from food contact uses."

Nonetheless, the FDA pledged to consider the NTP's recent conclusions, and agreed with the call for further research. The diverging opinions at the federal level may invite state action; The New York Times noted that some states are considering bills to restrict the use of BPA in children's products.

Read about the NTP's report and read more about the issue at niehs.nih.gov. 

View the FDA's draft report at fda.gov.

• Email This
• Print
• Comments
• Trackbacks
• Share Link