US regulators frequently send warning letters to all sorts of companies for alleged violations and deficiencies; everyone from drug and device manufacturers, to institutional review boards, to small supplement manufacturers.

But rarely, as the US Food and Drug Administration (FDA) did last week, do they send one regarding homeopathy products or to an online diploma mill-an unusual combination if there ever was one.

Background

Homeopathic products are usually just water, with the original product diluted so many times as to be chemically absent or ineffective. Many critics claim the products "work" only as placebos. A 30X homeopathic solution, for example, would have just one molecule of active ingredient in a solution with one decillion molecules-that's one in 1,000,000,000,000,000,000,000,000,000,000.

In the UK, some homeopathic manufacturers have threatened to avoid regulations entirely by marketing themselves as confectionary products, turning this perceived weakness into a potential source of strength.

In the US, however, the products operate on a fairly well-established regulatory framework: The products can make general claims, but are not allowed to market themselves as curing or treating any specific disease.

Warning Letter

A website hosted by the University of Berkley-an institution the Post Gazette referred to as a "notorious degree mill," and not to be confused with the University of California system's Berkeley University-though, seems to have violated that regulatory and legal framework by promoting a homeopathic flu product.

A 7 September 2013, warning letter sent to the school regarding its influenza prevention program references a website, since removed but available in cached versions online, that offered a "homeopathic flu product" that dubbed itself the "most effective alternative to the flu shot."

The university's website said people should protect themselves using the "Berkley-Body Immune" program, which it offered for between $90 and $170, depending on the amount of product purchased.

The website further claimed that unlike other products, which it said only treated the symptoms of the flu, its product treated the underlying symptoms of the disease using "energetic synergistic properties of the specific ingredients."

FDA Response

But even as the flu has been a "scourge to mankind for centuries," the webpage in question has been a scourge to federal officials since at least 11 January 2013, when it became aware of the website and began to investigate.

The website goes on to make the disclaimer that, "These statements have not been evaluated by FDA," and states that the products "are not intended to diagnose, treat, cure or prevent any disease."

But regulators said the webpage had done exactly that by positioning the product as an "alternative to the flu shot" that offered protection against the influenza virus.

"The marketing and sale of unapproved or uncleared flu virus -related products is a potentially significant threat to the public health," officials wrote in the warning letter. "Therefore, FDA is taking urgent measures to protect consumers from products that, without approval or authorization by FDA, claim to diagnose, mitigate, prevent, treat or cure Flu Virus in people."

The website was ordered to cease marketing, and has since been entirely removed from the university's website.

Broader Effort

FDA's actions in regards to the flu virus are its second in as many weeks. On 30 January 2012, agency officials issued a rare, multi-agency warning letter slamming a botanical product that claimed to be effective and afford protection against the flu virus. That letter was sent in conjunction with the Federal Trade Commission and issued just days after the alleged violations were discovered-an unusual amount of speed for an agency that usually takes upwards of one month to issue a warning letter.

The agency has also been dealing with spot shortages of the flu vaccine as the US grapples with an unusually strong flu season. FDA said it was particularly concerned about Berkley's marketing of its homeopathic product as a way to circumvent those shortages.

"Health experts at Berkley recommend Homeopathic/Naturopathic treatment to prepare for the upcoming flu season due to shortage [sic] in flu vaccines," the website claimed.

Based on FDA's warning letter, regulators seem to have given the university's claim-along with its other ones-a failing grade.