Homeopathic firm working to deal with FDA warnings
A Berkeley Springs homeopathic company has been warned by the U.S. Food & Drug Administration (FDA) to stop making claims that its products can prevent or treat illnesses and diseases.
Washington Homeopathic Products was officially warned about its promotion of Influenzinum in a letter dated October 6.
Due to the swine flu pandemic, the FDA has been cracking down on manufacturers that are making unproven claims that their products can treat or prevent flu.
In the case of Influenzinum, the warning letter stated that Washington Homeopathic Products is promoting the remedy to treat medical conditions, but it is not an approved drug.
Influenzinum is made from highly diluted flu vaccine and has never been shown to be effective, according to the FDA.
Washington Homeopathic was warned that the information on the company's website was false and misleading. About 140 company websites received warnings nationwide.
The October 6 letter to Washington Homeopathic read: "Your website makes effectiveness claims, but it lacks adequate descriptions of the risks, warnings and contraindications of your products."
Washington Homeopathic has changed their packaging and website information to say Influenzinum is simply "for flu-like symptoms."
Influenzinum is made by several other alternative health companies in addition to Washington Homeopathic Products.
The FDA's warning letter also instructed the Berkeley Springs firm to stop making similar treatment or prevention claims for other products, though only Influenzinum was specifically named.
Previously, the federal agency criticized the company's promotion of products for rheumatism, gout, learning difficulties and senility.
Washington Homeopathic Products has offices and manufacturing facilities on Fairfax Street in Berkeley Springs and in the U.S. 522 Business Park.
The company is owned by Joe and Linda Lillard, who were named West Virginia Small Business Persons of the Year last May and were guests at a White House reception.
When Joe Lillard bought the firm in 1991, it had three employees based in Washington, D.C. and annual sales of about $150,000.
The company now employs 38 people, makes more than 1,700 different remedies and has annual sales of more than $2.5 million.
The October letter was the second warning that the company received in recent months.
On August 25, the FDA sent a 14-page document to Washington Homeopathic citing a number of questions and apparent violations based on inspections done in March and April.
Some of the violations were said to be repeated from earlier warnings dating to a November 2007 inspection.
Among the most serious issues raised was the firm's handling of a homeopathic version of penicillin. Since production begins with a minute quantity of penicillin which is then highly diluted, the FDA raised concerns of potential allergic reactions.
"The risk of cross contamination from manufacturing penicillin, even in dilute form, is considered high," wrote Evelyn Bonnin, the FDA's Baltimore District director.
The letter warned that the same equipment is used to make homeopathic penicillin, homeopathic rabies vaccine and other remedies. Non-penicillin products were not being tested for cross-contamination, it said.
The FDA also claimed that Washington Homeopathic made "unapproved new drugs," including homeopathic preparations of prescription drugs Prednisone, Lidocaine and the anti-epileptic drug Keppra,
"There are no FDA-approved applications on file for the above products," which the FDA Compliance Guide does not consider homeopathic drug products, Bonnin wrote.
Joe Lillard said the company immediately ceased making homeopathic versions of prescription drugs after receiving the warning letter.
Washington Homeopathic had long created the remedies to fill special orders from doctors and sold them only to doctors, he said.
The homeopathic versions were intended for patients allergic to the regular drugs. The products have been recalled, Lillard said.
The FDA also claimed that some of the company's source materials dated to 1991, when Lillard purchased Washington Homeopathic, and there are no records of tests to verify purity. stability or potency.
The company has been replacing older source material with new material and reformulating products for some time, Lillard said.
Trying to get it right
Despite the warnings, Lillard said, "I don't feel like I'm in a combative relationship with the FDA."
He has hired consultants to help him respond to the agency's complaints.
"We're keeping them informed. We're making progress. We haven't injured anybody," Lillard said.
Misty Householder, the company's marketing manager, said many of the problems aren't about the quality of the products but about the documentation required by the FDA.
"It all boils down to improving our documentation process," she said.
"Joe's goal when he purchased the company was to provide high quality homeopathic medicines and we're going to keep that as a goal," Householder said. "With our business, there's always room for improvement."
"We really try to do right," Lillard said. "It's always been alright in the past. They find it and we straighten it out."
"Whatever the FDA says we should be doing, we should be doing," he said.