WASHINGTONIn September, FDA warned Standard Homeopathic Co. Inc. that a number of earache and other products were prescription drugs whose labeling claims were false or misleading because they are not appropriate for over-the-counter (OTC) drug treatment. 

Based on a review of the company's websites, FDA raised concerns over stated intended uses for arthritis, earaches, gum inflammation, vaginal itching and a number of other ailments.  

The warning letter was significant in the centuries-old homeopathic industry, which is often relied upon to treat a cold, the flu or a sore throat, because Standard Homeopathic Co. is one of the largest U.S.-based manufacturers of homeopathic remedies.

Mary Borneman, a spokesperson for Standard Homeopathic Co., acknowledged receiving the warning letter. She declined a phone interview, citing the advice of counsel.

"Hylands [a division within Standard Homeopathic Co.] has always marketed its products to address self-diagnosable conditions and symptoms, as required for over-the-counter medicines," she told Natural Products INSIDER in an emailed statement. "Hylands understands the FDAs perspective on drug use indications and believes it can resolve those concerns while continuing to provide these same great products to consumers. Hylands continues to conduct a careful review of all of its product labels to proactively address any other potential labeling issues."

The warning letter was not the first admonition Standard Homeopathic Co. has received in recent years. In a 2011 letter, FDA warned it previously identified a number of violations of cGMPs (current good manufacturing practices) for finished pharmaceuticals, rendering the products adulterated. The agency also argued that certain productsincluding tablets to help children who wet the bedwere prescription drugs based on labeling claims.

The letters were addressed to a man who is considered a leader in the industry: Jay Borneman, Standard's Chairman and CEO. Homeopathy has been in the Borneman family for four generations. Jay Borneman also serves as president of the Homeopathic Pharmacopoeia Convention of the United States (HPCUS), which functions "as the publisher of the official compendium for homeopathic drugs," Standard Homeopathic Co. spokesperson Mary Borneman explained. That compendium (Homeopathic Pharmacopoeia of the United States) has been in existence since 1897.

Homeopathy has grown into a substantial business since its basic principles were devised by the German physician Samuel Hahnemann in the late 18th century. According to the 2007 National Health Interview Survey, an estimated 3.9 million adults and 910,000 children used homeopathy in the prior year.

"The practice of homeopathy," FDA has explained, "is based on the belief that disease symptoms can be cured by small doses of substances which produce similar symptoms in healthy people."

It's estimated that 2012 retail sales of homeopathic and herbal remedies grew 2.6 percent to USD $6.4 billion, according to the market research firm Mintel. Mintel forecasts that sales will climb to $7.5 billion by 2017.

Homeopathic products have been classified as drugs under the Federal Food, Drug, and Cosmetic Act since 1938, according to a presentation from Jay Borneman. FDA explained the statute recognizes as official the drugs in the Homeopathic Pharmacopeia of the United States.

"However, the FDA does not evaluate the remedies for safety or effectiveness," according to the National Center for Complementary and Alternative Medicine (NCCAM).

FDA acknowledged in both letters to Standard Homeopathic Co. that homeopathic products can be made and distributed without FDA approval if they are "intended solely for self-limiting disease conditions amenable to self-diagnosis (of symptoms) and treatment."

"Homeopathic products offered for conditions not amenable to OTC use must be marketed as prescription products," FDA wrote.

David Riley, M.D., a consultant and board member of the HPCUS, pointed out that nearly all homeopathic products are marketed as OTC.

The warning letters are not confined to Standard Homeopathic Co. For instance, in a Sept. 19 letter to Homeolab USA Inc. in connection with its product "Kids Relief Earache", FDA referenced such labeling claims as "Relieve mild to severe ear pain", "Sooth throbbing pain & pressure" and "Reduce Inflammation."

"OTC treatment is inappropriate for ear pain because consumers cannot distinguish its symptoms from those of more serious disorders of the ear or adjacent tissues which are not amenable to OTC treatment and which can lead to serious injury if not accurately diagnosed and treated by a licensed health care professional," wrote Thomas Cosgrove of FDA's Unapproved Drugs and Labeling Compliance.

Homeolab declined to comment.

A Sept. 19 letter to Dolgencorp Inc. (d/b/a Dollar General) raised similar concerns in connection with the company's "Rexall Earache Relief Drops." Dollar General spokesman Dan MacDonald said a solution has been proposed to resolve FDA's concerns.

"Our vendor, which is responsible for regulatory compliance,  has agreed to change some of the labeling on the packaging to ensure this product is in compliance with FDA guidelines," he told Natural Products INSIDER. "For instance, the vendor will remove the term 'earache' from the name on the packaging and will also remove language that relates to pain relief or symptoms of earache. We have shared this information with the FDA. The next step is for our vendor to provide the actual packaging to the compliance officer which should conclude the matter."

The American Association for Homeopathic Pharmacists declined to comment on FDA warning letters. The HPCUS also declined comment.

FDA's Compliance Policy Guide (CPG) sets out conditions under which homeopathic products may be marketed in the United States. OTC drugs must bear on a label "at least one major OTC indication for use, stated in terms likely to be understood by lay persons."

The guide was first issued in 1988, became effect two years later and was revised in 1995. But Riley said it can be challenging to determine which illnesses are amenable to self-treatment.

According to the CPG, the criteria specified in Section 503(b) of the Federal  Food, Drug, and Cosmetic Act determines the prescription status for drug products, including homeopathic drugs. That section gives a broad definition to the term "prescription drug". One category includes "a drug intended for use by man which because of its toxicity or other potentiality for harmful effect, or the method of its use is not safe except under the supervision of a practitioner licensed by law to administer such a drug."

Federal law doesn't just apply to the determination of whether a homeopathic product is a prescription drug. Based on the strength of a product, the HPUS may distinguish between an OTC product and prescription drug, the CPG explains. If the HPUS makes such a distinction, the criteria that is more stringent than Section 503(b) will apply.

"In general, we recommend that companies marketing homeopathic drugs take a close look at their product line and ensure that they are following all conditions of the homeopathic CPG, particularly with respect to ingredient content, OTC v. Rx indications, and current Good Manufacturing Practice (cGMP), said Tara Goodin, a spokesperson with FDA.