By: Jeffrey Lapin
On January 29, 2013, the Food and Drug Administration (FDA) sent a “Warning Letter” to a Florida herbal supplement manufacturer alleging problems in their manufacturing process as well as marketing, on their website, some of their supplements as a “drug,” in violation of the Federal Food, Drug and Cosmetic Act (FD&C Act.). The marketing violation, based, in part, on results from the website’s search tool, seemingly indicates that the FDA is looking at “keywords” and metadata in determining whether a product’s online marketing violates the Act.
THE FD&C ACT AND THE FDA
The Federal Food, Drug, and Cosmetic Act (FD&C Act), originally passed in 1938, among other things, gave the U.S. Food and Drug Administration (FDA) the power to oversee the safety of food, drugs, and cosmetics. It has been amended several times to include additional powers and supervision over other things by the FDA and other U.S. agencies. The FD&C Act can be found in the U.S. Code beginning at 21 U.S.C. 301.
The FDA is an agency within the U.S. Department of Health and Human Services. According to its website the FDA is responsible for:
- Protecting the public health by assuring that foods are safe, wholesome, sanitary and properly labeled; human and veterinary drugs, and vaccines and other biological products and medical devices intended for human use are safe and effective;
- Protecting the public from electronic product radiation;
- Assuring cosmetics and dietary supplements are safe and properly labeled;
- Regulating tobacco products;
- Advancing the public health by helping to speed product innovations; and
- Helping the public get the accurate science-based information they need to use medicines, devices, and foods to improve their health.
KEYWORDS AND METADATA
Metadata is usually defined as “data about data.” Data.gov expands on this definition, “Metadata describes a number of characteristics, or attributes, of data; that is, ‘data that describes data’.”. NISO, the National Information Standards Organization, a non-profit association accredited by the American National Standards Institute (ANSI), identifies, develops, maintains, and publishes technical standards to manage information in our changing and ever-more digital environment. A NISO publication states,
There are three main types of metadata: Descriptive; Structural and Administrative … Metadata can describe resources at any level of aggregation. It can describe a collection, a single resource, or a component part of a larger resource. … Metadata can be embedded in a digital object or it can be stored separately. Metadata is often embedded in HTML documents and the headers of images. … An important reason for creating descriptive metadata is to facilitate discovery of relevant information.
“Keywords” have been defined as:
Used to describe the content of the resource. The element may use controlled vocabularies or words or phrases that describe the subject or content of the resource.
More simply, a keyword is a word or phrase that basically describes what it is you are looking for. Website designers can manipulate metadata so that certain pages or information show up based on keyword searches.
FDA REGULATION OF KEYWORDS AND METADATA
On January 29, 2013, Emma Singleton, Director, of the FDA’s Florida District, sent a “Warning Letter” to M.D.R. Fitness Corporation, which manufactures and sells herbal supplements, regarding alleged manufacturing practice deficiencies as well as a handful of supplements being marketed on their website as a “drug,” which would violate the Federal Food, Drug and Cosmetic Act (FD&C Act.). This Warning Letter states, in part:
In addition, typing the key word “cancer” or “diabetes” into your product search field located on your website brings up your product lists to include … [certain product listed] and others, implying your products are intended for use in the diagnosis, cure, mitigation, treatment or prevention of such diseases.
The full FDA Warning Letter can be found on the FDA’s website: M.D.R. Fitness Corp. 1/29/13.
This sentence can be interpreted to mean that a simple keyword search on the site that brings up results that “imply” that a product is intended for an FDA-unapproved use would be enough to be in violation of the FD&C. It is not known to this author how MDR’s search results are determined, whether based on metadata or other data coding. If this is the FDA’s new policy, it would appear that it will be actively searching drug and herbal supplemental company websites to determine whether there are “implications” of wrongdoing. This will require both manual visual searches of the sites themselves and possibly an examination of the “invisible” metadata.
While the FDA should fulfill its legal duty to protect consumers against misfounded, misleading or false claims by drug and herbal supplements makers, the bigger question is how does the FDA intend on reviewing these sites within its current budget. It also, presumably, would require the hiring of web specialists trained in reviewing metadata and similar web design coding. Furthermore, is this just a first step into governmental scrutiny into other areas that it governs on the internet. Most importantly, will U.S. Constitutionally protected free speech eventually be regulated online, including not only the actual content but its underlying metadata?
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