The US Food and Drug Administration (FDA) has sent a new Warning Letter to a company regarding claims it made on Facebook, which the agency alleges violate federal law.
FDA regulates the commercial speech of pharmaceutical and dietary supplement manufacturers under the Federal Food, Drug and Cosmetic Act (FD&C Act), which allows the agency to restrict the types of claims made about products which have not been approved by FDA for an explicit purpose. Specifically, companies cannot claim their product cures, mitigates, treats or prevents a disease unless they have received FDA approval to do so.
Dietary supplements, which are more loosely regulated by FDA as food-like products, have further restrictions on their promotion, and cannot make any claims restricted for drug products ("cure, mitigate, treat or prevent"). Rather, they can only make claims that a supplement product "supports" the structure or function of the body.
These restrictions are a constant source of contention for some marketers of dietary supplements, who often find themselves in the crosshairs of FDA. While FDA's focus on the improper promotion of dietary supplements isn't new, the agency's focus on the social media accounts of those companies is.
Since 2013, FDA has twice sent letters to supplement companies chiding them for the promotion of their products on the social media website Facebook, alleging that claims made by customers on the site and subsequently "liked" by the companies constituted an endorsement of those claims. In Warning Letters to AMARC Enterprises in February 2013 and Zarbees in July 2014, FDA said because the endorsements were for claims restricted to approved drugs under the FD&C Act, the companies' products were misbranded under federal law.
The agency has issued about two dozen other Warning Letters regarding the use of Facebook to supplement companies, generally for more traditional violations of the FD&C Act: that a company made claims which caused its product to be an unapproved drug under the law. Consider the wording of FDA's first-ever Warning Letter to a company regarding Facebook:
"Your product is not generally recognized as safe and effective for the above referenced uses and therefore, the product is a “new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. Furthermore, your product … is misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] because the product is offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, therefore, adequate directions cannot be written so that a layperson can use the product safely for its intended uses. The introduction of a misbranded drug into interstate commerce is a violation of section 301(a) of the Act, [21 U.S.C. § 331(a)]." – FDA Letter to Aloe Elite, 2011
FDA has also expressed its interest in claims made on other social media channels, including Twitter and Pinterest. The agency, some industry observers have noted, seems more interested in the message than in the medium in which the message is conveyed.
New Reliance on Social Media
Now, yet another company has found itself on the receiving end of FDA's social media scrutiny.
In a 16 October 2014 Warning Letter to California-based Vitalab Co., FDA alleges that several of the company's web properties—including its Facebook account—made claims prohibited by the FD&C Act. In particular, the company's "Vit-Ra-Tox" products were promoted using claims that implied they could be used to treat cholera, acute bacterial food poisoning, escherichia coli, staphylococcus and even broken bones.
The letter is notable in that FDA relies almost exclusively on claims made on Vitalab's Facebook page to substantiate its letter. "The therapeutic claims on your companies' websites and Facebook pages establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease," FDA wrote.
In comparison, most other Warning Letters issued by FDA rely more on statements made on a company's traditional website, the ownership of which is easier to prove.
FDA's lengthy Warning Letter to the company also chides it for manufacturing deficiencies and for failing to add important warnings to its products’ labels, including one that an iron-based product made by the company could cause fatal poisoning in children under the age of six.
FDA inspectors also said they "observed" that the company's manufacturing and quality employees were "not familiar with dietary supplement cGMP requirements and do not understand how to establish and follow quality control procedures.
Vitalab has 15 days from the issuance of the Warning Letter to respond to FDA's claims.
FDA Warning Letter to Vitalab