FDA Sued by Animal Rights Advocates and Ear (Holistic) Candle Advocates

By Kurt R. Karst –

It seems to be a popular headline these days: “FDA Sued Over [take your pick].”  Following the frenetic losartan 180-day litigation – which is still not over, as FDA has filed a petition for panel rehearing and rehearing en banc of the D.C. Circuit's March 2, 2010 decision in Teva Pharms USA, Inc. v. Sebelius, 595 F.3d 1303 (D.C. Cir. 2010), and Roxane Laboratories, Inc. has appealed to the D.C. Circuit the D.C. District Court’s April 2, 2010 ruling denying Roxane’s preliminary injunction motion – FDA has been hit with two new lawsuits. 

First, on April 6, 2010, a coalition of animal rights advocates filed a complaint in the U.S. District Court for the District of Columbia seeking declaratory and injunctive relief to require FDA to substantively respond to a November 2007 citizen petition.  That petition posits that “FDA has the authority to mandate the use of nonanimal alternatives and to restrict the use of animal test methods for purposes of FDA approval,” and “requests that the FDA exercise this authority to promulgate a regulation mandating that investigators and testing facilities use scientifically satisfactory non-animal replacements for animal-based methods when meeting the requirements of the Federal Food, Drug and Cosmetic Act.” 

According to the petitioners, the requested regulation is needed to eliminate or greatly reduce the use of “ineffective and costly animal testing methods that fail to identify the dangerous and lethal effects of drugs and devices on humans, and yet needlessly inflict pain and suffering on millions of animals each year.”  Although FDA has stated in letters related to the petition (here and here) that “FDA suggests and encourages the development, validations, and utilization of alternatives to animal testing,” the Agency has not formally responded to the citizen petition.  The animal right advocates who have sued FDA allege that the Agency has failed to comply with the Administrative Procedure Act (5 U.S.C. § 555(b) and the Agency’s citizen petition regulations (21 C.F.R. § 10.30(e)) by failing to substantively respond to the November 2007 petition within “a reasonable time,” and request the court to compel FDA to provide a timely substantive response.  Historically, courts have been hesitant to grant such relief (see e.g., here).

Second, earlier this week, a group of ear candle advocates sued FDA after the Agency issued about 15 Warning Letters to companies marketing the products.  According to FDA, ear candles are “hollow cones that are about 10 inches long and made from a fabric tube soaked in beeswax, paraffin, or a mixture of the two” that are being marketed as treatments for a variety of conditions, including “ear wax buildup, sinus infections, hearing loss, headaches, colds, flu, and sore throats.”  Ear candling, also known as “ear coning” or “thermal-auricular therapy,” is an alternative medicine practice that advocates claim improves general health and well-being.  

FDA’s Warning Letters (see e.g., here) state that the products are unapproved medical devices and requests that the companies cease marketing and distributing their products:

Specifically, the ear candle is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. 351(f)(1)(B), because you do have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g)of the Act, 21 U.S.C. 360j(g).  Your device is also misbranded under section 502(o) of the Act, 21 U.S.C. 352(o), because you did not notify the agency of your intent to introduce the device into commercial distribution for the intended uses discussed above, as required by section 510(k) of the Act, 21 U.S.C. 360(k).

This is not the first time FDA has taken enforcement action against companies marketing ear candles.  FDA issued similar Warning Letters in 1998 – here and here.

The ear candle advocates (they refer to the products as “Holistic Candles”) allege in their complaint that “Holistic Candle is a generic product that is exempt from defendant FDA’s regulation requirements.”  According to the Plaintiffs:

Holistic Candles are not medical devices.  Properly made Holistic Candles are a natural holistic modality are used for and intended to be used for relaxation, comfort, reduction of stress and for the natural furtherance of the well-being of the user.  The relaxation process, from the viewpoint of any alternative health modality, is for the fostering of and the support for the human body’s own propensity to spontaneously seek natural homeostasis, via relaxed and stress-reducing circumstances, catalysts, or environments.

Such traditional and intended use, usually in a family or private association context does not “treat or cure” any condition of illness, and does not specifically affect any body function.  Alternative modalities simply allow the body to do what the human body does naturally, and that is to find a proper and necessary balance between the integrated components of the mind-body-spirit. This, in essence, is what homeostasis is.

The ear candle advocates seek “that proper Disclosure and Disclaimers be given with regard to Holistic Candles, to save them from being considered Medical Devices,” and contend that Holistic Candles are not medical devices, or if they are, that “they are exempt from registration as Class I Devices,” and if “Holistic Candles are not exempt Class I Devices,” then they are grandfathered “as having been in use prior to 1974.”  (The reference to 1974 should be 1976.  Under the FDC Act, certain devices that were legally marketed prior to the May 28, 1976 enactment of the Medical Device Amendments, and which have not been significantly changed or modified since that time – so-called “preamendment” or “grandfathered” devices – do not require submission of a premarket approval application (“PMA”) (or a 510(k) premarket notification) until after FDA issues a final rule requiring a PMA for that device.)