After issuing a public warning regarding the dangers of tanning nearly three years ago (see our previous blog here), this week the U.S. Food and Drug Administration (“FDA”) issued a proposed order to reclassify sunlamp devices and require labeling changes to include a warning discouraging young people (those under 18) from using them.

If finalized, this proposed order would reclassify sunlamp devices from a class I (low risk) device to a class II (moderate risk) device requiring premarket notification and stricter controls. FDA’s authority to reclassify a device is based on section 513(e) of the Food, Drug, and Cosmetic Act (“FDCA”) which allows FDA to reclassify a device based upon “new information” through an administrative order. As the proposed order explains, “new information” includes information developed as a result of reevaluation of the data before FDA when the device was originally classified. If finalized, this order will heighten the regulatory requirements for tanning bed manufacturers and distributors doing business in the United States.

I. Regulatory History of Sunlamps

The proposed order takes us through the regulatory history of sunlamps. In 1977, the review panels evaluating sunlamp devices recommended that dermatologic UV lamps (intended for use in treatment of dermatologic disorders or for tanning) be deemed class II devices. The reason for this classification being that the panels perceived there to be risks that could not be mitigated with general controls. The identified risks included burns to skin and eyes, aging of skin, skin cancer, and photosensitivity. FDA agreed with the panels’ recommendation. However, in FDA’s final rule, published June 24, 1988 (53 Fed Reg 23856), FDA separated UV lamps for dermatological disorders and UV lamps for tanning. At that time, FDA classified the lamps for dermatological disorders as class II and postponed classification of tanning lamps to consider issuing a proposal classifying them as class I. FDA eventually finalized that classification in November of 1990 (55 Fed Reg 48436). In 1994, FDA amended that classification and published a final rule exempting 148 class I devices from premarket notifications with some limitations, including UV lamps for tanning (59 Fed Reg 63005).

Classifying sunlamp products for tanning as class I devices meant FDA determined that manufacturer premarket notifications for these devices were necessary to protect the public health at that time. In its new proposed order, FDA notes that “[p]rior to the issuance of the 1994 exempting UV lamps for tanning from premarket notification submission, some manufacturers of UV lamps for tanning had already submitted 510(k)s and received clearance for their devices.” Should this proposed order be finalized, device manufacturers may use those devices as predicate devices for future 510(k) submissions.

II. Stricter Classification – 510(k) Process

FDA requires a premarket notification submission (a “510(k)”) for class II medical devices, i.e. devices that are moderate risk and require special controls. Class I, or low risk devices, only require general controls and are not required to submit anything to FDA to begin marketing. During the 510(k) process, FDA reviews technological characteristics, performance, intended use, and labeling of medical devices to ensure the devices are “substantially equivalent” to legally marketed predicate devices before they enter the market. The 510(k) process can be described as a “piggybacking” system with one device piggybacking on the FDA clearance of another, similar device. As FDA explains in the proposed order:

Substantial equivalence requires that a new device must have (1) the same intended use as legally marketed predicates, and (2) either the same technological characteristics as a legally marketed predicate, or if there are significant differences, the differences must not raise new questions of safety and effectiveness and the performance data must demonstrate that the new device is at least as safe and effective as the legally marketed predicate device. (See section 513(i) of the [FDCA].) This assures that new devices that differ significantly in terms of safety and effectiveness from devices already legally on the market will be subject to the more rigorous premarket approval requirement.

In its proposed order, FDA is proposing this heightened classification because it has identified several risks related to UV lamps for tanning. These risks are similar to those identified in 1977 and include increased skin cancer risk, ocular risk, burns to the skin, skin damage, transmission of infectious disease due to improper cleaning, and others. FDA cites a growing body of literature on the association of skin cancer with use of sunlamp devices.

III. Proposed Reclassification and Special Controls, Including Labeling Requirements

FDA is proposing that sunlamp products be reclassified from class I (general controls) to class II (special controls). FDA reasons that general controls alone are insufficient to provide reasonable assurance of safety and effectiveness. FDA has identified special controls it believes will be sufficient to ensure safety and effectiveness for these devices. These special controls include, among others, performance testing, demonstration of mechanical safety, demonstration of electrical safety and electromagnetic compatibility, and specific product labeling.

The proposed labeling requirement includes several warnings. First, it would discourage use of sunlamp devices to those under the age of 18 and those with a personal history or family history of skin cancer. Additionally, the labeling would include a warning that regular users of these types of devices be regulatory evaluated for skin cancer. FDA’s proposed order also suggests that labeling requirements include warnings related to transmission of infectious disease through improper cleaning would mitigate that risk. Furthermore, FDA proposes that a warning be included that these devices should not be used by those with skin lesions or open wounds. Should this proposed order take affect and these warnings be required on tanning beds, it will be interesting to see if there is actually a decrease in tanning bed use by young people. With these warnings, FDA is merely discouraging sunlamp use by young people and not prohibiting their use by anyone under the age of 18. The efficacy of these warnings is called into question even by the proposed order. The FDA cites a study in its proposed order that reported “47 percent of college student had reported using a sunlamp product during the last year because it improved their appearance, despite 92 percent being aware of potential health risk.” (Emphasis added.) That study alone indicates that young people will likely continue the use of tanning beds despite warnings regarding health risks.

IV. Potential Effects on Industry

FDA will take comments on this proposed order for the next 90 days. Any member of the industry or general public may comment on it. Should FDA move forward with finalization of this order, there will be major changes to the regulatory framework governing the tanning bed industry. Upon finalization of this order, FDA has expressed that it expects sunlamp manufacturers to submit a 510(k) and comply with the special controls within one year of the date of the final order or cease marketing their devices. This expectation will apply to sunlamp devices already on the market, meaning that manufacturers of sunlamp devices currently sold in the United States without 510(k) clearance would be expected to obtain 510(k) clearance before continuing sales. Due to the protracted time periods the 510(k) process can take, tanning bed manufacturers should be prepared to move forward with a 510(k) submission if finalization of this rule occurs in order to avoid delays in distribution.

Fuerst, Ittleman, David & Joseph, PL will continue to track and report on FDA’s position related to these types of devices. For more information, please contact us via e-mail at contact@fidjlaw.com or via telephone at (305) 350-5690.

In 2009, the U.S. Food and Drug Administration (FDA) announced that it intended to release a guidance document explaining how it will regulate industry’s use of social media to advertise products or communicate with consumers. As of today, the FDA still has not done so, and as a result, a regulatory gray area has been created, wherein industry is forced to weigh the risk of reaching out to its consumers through popular forms of social media, such as Facebook or Twitter, with no clear guidelines regarding how to do so. Despite the FDA’s failure to provide industry with any guidance on the proper use of social media in compliance with federal laws and policies, the FDA has not backed down from taking enforcement action for what it views as improper use of social media channels.

FDA Takes Enforcement Action Against Advertiser for “Liking” Consumer’s Facebook Comment

On December 11, 2012, the FDA issued a Warning Letter to AMARC Enterprises (“AMARC”) for claims made on its Facebook account that purportedly promoted its dietary supplement, PolyMVA, as a drug intended for use in the cure, mitigation, treatment, or prevention of disease. (To read the FDA’s Warning Letter to AMARC Enterprises, please click here.) Specifically, the FDA noted that the PolyMVA Facebook page “liked” a comment posted by a consumer, which stated that “PolyMVA has done wonders for me. I take it intravenously 2x a week and it has helped me tremendously. It enabled me to keep cancer at back without the use of chemo and radiation”¦Thank you AMARC.” This claim was included as one of several examples of the company promoting PolyMVA “for conditions that cause the product to be a drug.”

In issuing this Warning Letter to AMARC, the FDA took an unprecedented position on the use of social media to promote or advertise FDA-regulated products. Specifically, this Warning Letter implies that the FDA views the company’s act of “liking” comments or posts on Facebook as akin to adopting or endorsing the underlying claim itself. Although the FDA did not elaborate on or specifically explain how “liking” a user’s comment constitutes drug promotion, it seems that the FDA perceives “liking” a third-party’s comment as creating an implied disease claim. The FDA’s Warning Letter sends a strong message to industry that it should be cautious in its use of Facebook’s “like” function because “liking” a comment or post could inadvertently result in closer FDA scrutiny of those consumer claims. It remains to be seen whether the FDA’s unofficial policy regarding “liking” Facebook comments will be extended to other popular social media venues, such as Twitter, where users can “re-tweet” or “favorite” a message, or Google+, where users can “+1” a post.

FDA Holds Advertiser Responsible for How Consumers Interpret Computer-Generated Search Results

In a second Warning Letter to M.D.R. Fitness Corp. (“M.D.R. Fitness”) dated January 29, 2013, the FDA took the company to task regarding its website. (To read the FDA’s Warning Letter to M.D.R. Fitness, Corp., please click here.) Specifically, the FDA noted that typing well-known diseases like “cancer” or “diabetes” into a search field on the product’s website returned a list of the company’s dietary supplement products. According to the FDA’s Warning Letter, the results of this search create the implication that M.D.R. Fitness is promoting its dietary supplement products “for conditions which cause the products to be drugs” that are “intended for use in the diagnosis, cure, mitigation, treatment or prevention of such diseases.”

Even though the FDA only mentioned the company’s search engine as a passing comment in a list of other deficiencies, this statement has the potential to have significant effects on the regulation of industry. The FDA’s Warning Letter suggests that manufacturers can be held responsible for any associations consumers may make between a disease and a dietary supplement, including any information generated through a search engine. It is unclear whether the company’s search function strategically manipulated the results to include its dietary supplement products or whether the search function is built upon a dynamic tool like Google. This Warning Letter raises serious questions about the extent to which the FDA will hold manufacturers responsible for search results on their own websites and consumers’ interpretations of those search results. Based on the limited information in the M.D.R. Fitness Warning Letter, it seems likely that the FDA is now targeting manufacturers for creating implied drug claims based on no more than search results.

FDA Continues to Delay Release of Guidance on Social Media Use

In 2009, the FDA expressly stated that it planned to develop and issue guidance on the use of social media; however, the FDA has yet to issue any additional information or policies specifically related to the use of popular social media websites, such as Facebook, Twitter, or Google+. Other federal agencies, on the other hand, have recently provided some clarification on how to communicate information to the public through these social media outlets in compliance with federal laws and policies. For example, in March 2013, both the Federal Trade Commission (FTC) and Securities and Exchange Commission (SEC) released guidances that clarified how they intend to regulate the use of social media. (Please click here to access the FTC’s new guidance entitled “.com Disclosures: How to Make Effective Disclosures in Digital Advertising” and click here for more information about the SEC’s policy on the use of social media networks.) The FDA specifically stated that it has “placed developing social media guidance at the top of its work plan for 2013.” (For more information, please read the FDA News announcement here.) However, drug marketers may need to wait as late as a July 9, 2014 deadline for more detailed FDA guidance on allowable medical product promotions via the Internet and social media.

The FDA’s Warning Letters to AMARC and M.D.R. Fitness suggest that the FDA is in the process of shaping its enforcement policies regarding social media use. However, in the absence of any further guidance or information from the FDA regarding the use of social media to promote or advertise FDA-regulated products, industry will continue to face the challenge of operating these social media channels relatively blindly. Although it remains uncertain whether the FDA will continue to patrol search results on product websites or take enforcement action against companies for their use of social media prior to issuing a formal guidance document, these Warning Letters serve as notice to industry to exercise caution.

Fuerst, Ittleman, David & Joseph, PL will continue to monitor the developments in the FDA’s regulation of social media use. For more information, please contact us via e-mail at contact@fidjlaw.com or via telephone at (305) 350-5690.

On March 19, 2013, a group of doctors, researchers, and public health experts sent a joint letter to the Commissioner of the U.S. Food and Drug Administration (“FDA”) urging the FDA to make changes to the regulation of energy drinks. In its letter, the group concluded that there is a “robust correlation between the caffeine levels in energy drinks and adverse health and safety consequences,” especially where children, adolescents and young adults are concerned. Furthermore, the group claims that “there is neither sufficient evidence of safety nor a consensus of scientific opinion to conclude that the high levels of added caffeine in energy drinks are safe under the conditions of their intended use.” As a result of these findings, the group is pushing the FDA to require manufacturers to label energy drinks with the product’s caffeine content and demonstrate that the levels of caffeine in those products are generally recognized as safe (“GRAS”) and comport with existing GRAS standards for beverages.

The FDA has previously dismissed public concerns about the safety of caffeine levels in energy drinks. In an unpublished response to Senator Dick Durbin’s 2012 investigation of dietary supplements, which included energy drinks, the FDA explained that the amount of caffeine in energy drinks is not significantly different from the levels of caffeine in commonly consumed beverages like coffee or carbonated soda. (For more information, please see Natural Insider’s article here.) Furthermore, the FDA noted that most caffeine consumed by Americans comes from what is naturally present in coffee and tea and that a review of the available studies does not indicate any new, previously unknown risks associated with caffeine consumption.

Monster to Market Energy Drinks as Beverage Instead of Dietary Supplement

In a move unrelated to the letter described above, Monster Beverage, the largest seller of energy drinks, recently announced its plan to discontinue marketing its energy drink products as dietary supplements. Instead, Monster will market its products as conventional beverages. In addition to implementing required changes to its product labeling to reflect nutrition facts instead of supplement facts, Monster disclosed that its energy drink products will now specify caffeine content. (For more information about the change in the marketing of Monster energy drinks, please click here.) Monster’s announcement of its plan to shift the marketing of its energy drinks comes just a few months after another energy drink brand, Rockstar, made a similar move.

According to Joseph Cannata, an executive vice president at Rockstar, Rockstar made its decision to market energy drinks as beverages because consumers found food labels easier to read than dietary supplement labels. A spokesperson for Monster, Michael Sitrick, explained that Monster’s decision was influenced by several factors. Specifically, Mr. Sitrick stated that a major reason for the change was to stop the “misguided criticism” that Monster was selling its energy drinks as dietary supplements because dietary supplements are more lightly regulated than beverages. Additionally, Mr. Sitrick explained that “Monster Energy drinks could equally satisfy the regulatory requirements” for either dietary supplements or beverages. (For more information, please read the New York Times article here.)

These announcements from Rockstar and Monster Beverage come after a year of close public scrutiny over energy drinks. In July 2012, the parents of a 14-year-old girl filed a lawsuit against Monster after their daughter died following the consumption of two Monster Energy products. (For more information about this incident, please read CBS’s coverage here.) In November 2012, the FDA received several voluntary adverse health reports listing the dietary supplement 5-hour Energy as contributing to an illness or death. Subsequently, the FDA began a routine investigation to determine whether a possible link exists between the hospitalizations and 5-hour Energy. (For more information about this investigation, please read CBS’s coverage here.) In spite of these recent investigations, the FDA has not officially changed its position regarding the safety of consuming energy drinks.

FDA Regulation of Energy Drinks

The FDA does not have a specific category or specific regulations for energy drinks. Typically, energy drinks have been marketed as either dietary supplements or conventional beverages, depending on the product’s ingredient, intended use, and labeling. For manufacturers, determining the appropriate regulatory framework for a product has important implications on a product’s development, as it can help guide product formulation and establish the limitations on product labeling and marketing, any requirements for pre- or post-market reporting or mandatory adverse event disclosures to the FDA. As we previously explained here, categorizing products as either conventional foods or dietary supplements can be difficult.

The FDA defines conventional foods as “articles used for food or drink for man or other animals, chewing gum, and articles used for components of any such article.” All ingredients in conventional foods must be pre-approved by the FDA as a food additive or meet the requirements of the GRAS provisions. Dietary supplements, on the other hand, are defined as products “intended for ingestion that contain a dietary ingredient intended to add further nutritional value to (supplement) the diet.” Dietary supplements may be in forms such as tablets, capsules, softgels, gelcaps, liquids, or powder, and may be one, or a combination, of the following substances: vitamins, minerals, herbs or botanicals, amino acids, concentrates, metabolites, constituents, or extracts. Based on these definitions, it may be more difficult to classify certain liquid products where the product is intended to supplement the diet with vitamins or nutrients but resembles a conventional beverage in serving size and taste.

In an attempt to assist manufacturers in properly classifying their products as either liquid dietary supplements or conventional beverages, the FDA issued a draft guidance document in 2009. (The FDA’s Guidance document can be accessed here.) This 2009 draft guidance states that the FDA considers a product’s name, packaging, serving size, recommended conditions of use, and other representations about the product, to be determinants of whether the product is a conventional food or dietary supplement. This guidance has not been finalized; however, the U.S. Government Accountability Office released a report in March 2012 indicating that the FDA is in the process of developing and reviewing a final guidance document that clarifies when a liquid product should be marketed as a dietary supplement or conventional beverage. (The U.S. Government Accountability Office’s report can be accessed here.)

If a product is a conventional food or dietary supplement but improperly marketed as the other type of product, the product could be deemed by the FDA to be misbranded or adulterated in violation of 21 U.S.C. § 331(a) and 21 U.S.C. 342(a)(2)(C). Failure to comply with the appropriate labeling regulations could subject manufacturers to enforcement action. The FDA has issued Warning Letters against manufacturers for mislabeling conventional beverages as dietary supplements. (For more information about the FDA’s past enforcement action regarding the labeling of dietary supplements, please read our previous post here.)

Uncertainty Regarding the Future Regulation of Energy Drinks

Despite the FDA’s current position that the elevated caffeine levels in energy drinks do not pose a significant health risk, the public continues to pressure Congress and the FDA to address its concerns about the safety of consuming energy drinks. Now, with the release of this joint letter to the FDA, doctors, researchers, and public health experts seem to support the push for tighter regulation and increased oversight of these products. At this time, it remains to be seen what steps Congress and the FDA will take to address any gaps in the present regulatory scheme.

Fuerst Ittleman David & Joseph, PL will continue to monitor any developments in the regulation of compounding pharmacies. For more information, please feel free to contact our offices by email at contact@fidjlaw.com or by phone at (305) 350-5690.

As we previously reported, on September 27, 2010, the Federal Trade Commission (“FTC“) filed an administrative complaint against POM Wonderful LLC (“POM“) for allegedly making unsubstantiated claims, which were also false or misleading in violation of Sections 5(a) and 12 of the Federal Trade Commission Act (“FTC Act“). In its Complaint, the FTC alleged that POMs claims that its products prevent, reduce the risk of, or treat heart disease, high blood pressure, prostate cancer, and erectile dysfunction (“ED”) were not supported by competent and reliable evidence. Additionally, the Complaint contained a proposed cease and desist order that would require, among other things, U.S. Food and Drug Administration (“FDA“) approval of certain disease claims for POMs products.

On May 17, 2012, an FTC Administrative Law Judge (“ALJ”) held in an Initial Decision that POMs claims that its products could treat, prevent, or reduce the risk of heart disease, prostate cancer, and ED were deceptive because these claims were not supported by sufficient competent and reliable evidence. However, the Decision rejected the FTCs theory that competent and reliable scientific evidence for the disputed claims could only be satisfied with two double-blind, randomized placebo-controlled clinical trials (RCTs). Instead, the ALJ found that competent and reliable scientific evidence could be established without RCTs. The ALJ also held that FTCs proposed requirement that POM be prohibited from making any disease claim in the future unless the claim had been pre-approved by FDA “would constitute unnecessary overreaching.”

On June 18, 2012, both POM and the FTC appealed the Initial Decision to the FTC Commissioners. POM appealed all portions of the Decision relating to the finding of liability. The FTC appealed the ALJs decision arguing that (1) all advertisements challenged in the Complaint violated the FTC Act, (2) the substantiation of disease efficacy claims should require well-designed, well-conducted RCTs, and (3) the ALJ erred in not requiring FDA approval for all future claims. The appeal briefs for POM and the FTC can be read here and here respectively. For more information regarding the POM and FTC appeals please see our previous report here.

On January 10, 2013, the FTC Commissioners issued a Final Order approving the Initial Decision 5-0 that POM made deceptive claims about treating, preventing or reducing the risk of heart disease, prostate cancer and ED. However, the Final Order differs in some respects from the Initial Decision. The Commissioners rejected the ALJs conclusion that “RCTs are not required to convey information about a food or nutrient supplement where . . . the safety of the product is known; the product creates no material risk of harm; and the product is not being advocated as an alternative to following medical advice.” The Commissioners also rejected the ALJs determination that the level of substantiation may vary depending on whether the advertiser offers the product as a replacement for traditional medical care.

The Final Order requires POM to possess two RCTs in order to substantiate claims regarding a products effectiveness in the diagnosis, treatment, or prevention of any disease. The Commissioners noted that “[a]lthough [the Commissioners] did not need to decide how many RCTs are necessary to substantiate [POMs] disease claims in order to establish liability, [they] specify a two RCT requirement in the Order for two reasons. First, such a requirement is consistent with Commission precedent.” Second, POM has “demonstrated propensity to misrepresent to their advantage the strength and outcomes of scientific research, as reflected by [the Commissions] conclusion that [POM] made false and misleading claims about serious diseases, including cancer, in a number of the advertisements.”

The Commissioners agreed with the ALJs conclusion that FDA pre-approval is not warranted as part of the remedy. The Commissioners concluded that FDA pre-approval is unnecessary because the goals are sufficiently accomplished by requiring POM to possess at least two RCTs. Significantly, the Commissioners left open the issue regarding FTCs authority to require FDA pre-approval for disease claims. It remains to be seen whether the FTC will continue to include provisions regarding FDA pre-approval in FTC consent orders in other cases. However, as we have previously reported, the FTC has increasingly included FDA pre-approval provisions in consent decrees with companies such as Dannon and Iovate. Our reports can be found here and here, respectively.

POM has 60 days to appeal the Commissions Final Order to a United States Circuit Court of Appeals. See 5 U.S.C. § 45(c). Fuerst Ittleman David & Joseph, PL will continue to monitor the development of the POM case. For more information about food and dietary supplement claims or to have Fuerst Ittleman David & Joseph, PL complete a label and website review of your products, please contact us at (305) 350-5690 or contact@fidjlaw.com.