FDA warns Schwabe for homeopathic ingredients, claims

FDA took issue with a line of immune health products that combined homeopathic ingredients with non-homeopathic ingredients, taking the products out of the homeopathic drug classification.

February 28, 2012

3 Min Read
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  • Homeopathic ingredients cannot be combined with non-homeopathic ingredients; once they are, they are no longer considered homeopathic drugs and are subject to FDA premarket approval.

  • FDA does not consider a disclaimer that a product is not intended to treat, cure, prevent or mitigate a disease enough to neutralize disease claims that appear elsewhere.

MINNEAPOLISAccording to FDA, Schwabe North America Inc. mislabeled its products and made claims that turned the homeopathic remedies into drugs, according to a warning letter the agency sent Michael Devereux, chief executive officer of Schwabe.

FDA took issue with the Umcka® line of products, which include a number of products for immune health. The agency said these products combine homeopathic ingredients with non-homeopathic ingredients, taking the products out of the homeopathic drug classification. Further, FDA said a number of products in this line were associated with drug claims on the naturesway.com and umcka.com websites.  

Homeopathic drugs are regulated differently than other dietary supplements. They are subject to the same regulatory requirements as other drugs; however, many homeopathic drugs can be distributed without FDA approval under enforcement policies set out in the agency's Compliance Policy Guide (CPG), "Conditions Under Which Homeopathic Drugs May be Marketed (CPG 7132.15)." Per the CPG, a homeopathic drug must be listed in the Homeopathic Pharmacopeia of the United States (HPUS) and cannot contain homeopathic ingredients in combination with non-homeopathic active ingredients.

In the Umcka products, several approved homeopathic drugs are combined with Pelargonium sidoides, which is not included in the HPUS. Therefore, FDA said Pelargonium sidoides is not a homeopathic ingredient, and the Umcka products are not considered homeopathic drug products under the CPG.

FDA also the labeling  and website claims for these products in this line make them unapproved new drugs in violation of the Federal Food, Drug and Cosmetic Act (21 U.S.C. §§ 331 and 355). Even though a number of the pages on the websites contained a disclaimer stating the products are not intended to diagnose, treat, cure or prevent any disease, FDA said the Umcka products are drugs because they claim to mitigate or treat the common cold, flu, bronchitis, sinusitis and rhinitis. FDA said the disclaimer did not negate the other claims on the website. 

FDA also noted umcka.com references published studies, and includes summaries of a number of published studies regarding the  therapeutic uses of Pelargonium sidoides, which is identified as an active ingredient in all of the Umcka products. In the warning letter, the agency explained when scientific publications are used to sell a product, the publications may become evidence of the product's intended use. In other words, if a study refers to a disease treatment or prevention, a citation implies the product treats or prevents the disease.

FDA gave Schwabe 15 working days within the receipt of the letter to notify the agency in writing of the specific steps that it has taken to correct the violations.

Need help on your claims? Check out the on-demand video, "Strategic Plans for Globalization in Claims Compliance."

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