Regulatory Alert: FDA Metadata Enforcement Action

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The Food & Drug Administration’s (FDA) Los Angeles district office has issued a warning letter to Nature’s Health Supply for its promotion of a nutritional supplement. Among other factors, the FDA pointed to the metadata for the web pages as indicating that the supplements were drugs that had been introduced into interstate commerce without receiving FDA approval. This enforcement action highlights the awareness of the FDA to seemingly invisible content on websites, and the need to take appropriate measures to ensure that all metadata is compliant.Digitas Health provides recommendations for health and wellness companies to take in this Regulator Alert from VP/Group Director, Regulatory Review Dale Cooke.

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FDA Metadata Enforcement Action
July 30, 2013 Analyst: Dale Cooke

Regulatory Alert

EXECUTIVE SUMMARY
The Food & Drug Administration’s (FDA) Los Angeles district office has issued a warning letter to Nature’s Health Supply for its promotion of a nutritional supplement. 1 Among other factors, the FDA pointed to the metadata for the web pages as indicating that the supplements were drugs that had been introduced into interstate commerce without receiving FDA approval. This enforcement action highlights the awareness of the FDA to seemingly invisible content on websites, and the need to take appropriate measures to ensure that all metadata is compliant. Digitas Health recommends companies take the following actions: 1. Review existing protocols for the development of compliant website metadata. 2. Include website metadata as part of the promotional materials review submission for all websites. 3. Establish consistent standards to guarantee that all website metadata is on label and does not imply off-label or inappropriate product uses. 4. Submit metadata that is intended to be shared publicly to the FDA as part of the 2253 submission of websites. Digitas Health has procedures in place to ensure every website project we work on has compliant metadata. The enforcement action discussed is a reminder of the need to follow those procedures.

BACKGROUND
On July 15, 2013, the Los Angeles district sent a warning letter to Nature’s Health Supply indicating that its nutritional supplements were being promoted in such a manner as to meet the definition of a drug without having received FDA approval for a new drug. Consequently, the company was deemed to have violated the Food Drug and Cosmetic Act. In the warning letter, the FDA pointed to numerous claims made on the company’s website for the products. In that discussion, FDA spent several paragraphs documenting extensive claims, patient testimonials, and other evidence of the products intended usage as a drug. Then, FDA noted, “The claims quoted above are supplemented by the metatags used to bring consumers to your websites through Internet searches.” 2 Among the metatags cited by FDA were the following: “natural diabetes cure” and “natural cholesterol cure.” Metadata includes information that is for the most part not visible to users but enables search engines, such as Google, to index the site and make pages of the site available for users looking for the specific information provided by the site. Metadata includes the titles of pages that appear in Internet browsers, Alttags for images that are provided to the visually impaired, keywords that help search engines categorize

websites, and page descriptions that further help search engines determine whether an individual web page has the information a user seeks. Developing appropriate, compliant metadata is crucial to ensure that the people who want to find the information provided by the website are in fact able to find it. Inappropriate metadata makes a site virtually invisible to Google and other search engines, and that means far fewer site visits. Most metadata is only viewable as source code (seen at right below) in the final website, but promotional materials review committee members should review page titles, keywords, page descriptions, and Alt-tags as part of their review of any website. Page titles are visible in the top of the browser bar on each page, and certain metadata is used by sharing functionality, when sponsors enable site visitors to share the page they are visiting via Facebook, Twitter, and other platforms. 3

Sample Website Page & Source Code

IMPLICATIONS
Media reports have noted that this is not the first time FDA has cited metadata in an enforcement action. 4 The other actions taken by the FDA that explicitly targeted metadata have also come from district offices, not from the Office of Prescription Drug Promotion (OPDP). OPDP has not provided any explicit guidance on the use of metadata or what should be included with the 2253 submission of a website. 5 It is not clear whether the actions of the division offices set precedent for the views of OPDP. Regardless, it is clear that officials within FDA are aware of metadata and take their presence and content into consideration when evaluating the nature of the claims made by a product sponsor. There was one enforcement action from OPDP that explicitly discussed metadata, though it did not use the word “metadata.” In 2010, OPDP cited Novartis for a Facebook sharing widget. 6 That widget pulled certain metadata from the page’s source code and pushed the metadata onto the Facebook page of the site visitor. Among the violations FDA cited in its letter was the failure to submit the content that was shared under Form

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2253. Thus, it seems FDA is requiring that any metadata that is intended to be viewed by site visitors (or others) is submitted on Form 2253.

RECOMMENDATIONS
Digitas Health recommends companies take the following actions: 1. Review existing protocols for the development of compliant website metadata. 2. Include website metadata as part of the promotional materials review submission for all websites. 3. Establish consistent standards to guarantee that all website metadata is on label and does not imply off-label or inappropriate product uses. 4. Submit publicly facing metadata to the FDA as part of the 2253 submission of websites. Digitas Health has procedures in place to ensure every website project we work on has compliant metadata. The enforcement action discussed is a reminder of the need to follow those procedures. Note that Digitas Health is not a law firm, and the author of this document is not an attorney. Nothing in this document should be construed as offering legal counsel.

The letter was last accessed from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm361890.htm on July 30, 2013. 2 See Nature’s Health Supply letter. 3 FDA has taken an enforcement action against Novartis for non-compliant use of sharing functionality. That enforcement action can be viewed at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/Warnin gLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/ucm197224.htm last accessed July 30, 2013. For additional information on that action, see Digitas Health Regulatory Alert: FDA’s First Facebook Enforcement Action available at http://www.scribd.com/doc/35466006/Digitas-Health-Facebook-RegulatoryAlert-20100805 and Digitas Health POV: Online Sharing: What Pharma CAN Do available at http://www.scribd.com/doc/36008952/UPDATED-Digitas-Health-Online-Sharing-POV both last accessed July 30, 2013. 4 See, for example, “FDA Chides Company for Improper Use of Meta Tags on its Website,” Regulatory Focus, Regulatory Affairs Professionals Society, July 23, 2013 accessed from http://www.raps.org/focus-online/news/news-article-view/article/3824/fda-chides-company-for-improperuse-of-meta-tags-on-its-website.aspx on July 30, 2013. 5 During a July 29, 2013 Enforcement Actions Webinar, OPDP presenters were asked whether sponsors needed to submit keywords for websites under Form 2253. The presenters said that keywords do not need to be submitted. Keywords are not typically visible to a site visitor, unless the site visitor views the source code directly. Neither the transcript nor a recording of the webinar is yet available. 6 See http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/Warnin gLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/ucm197224.htm

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