Consumer Lawyers

FDA Warns Schwabe For Homeopathic Ingredientss

In Uncategorized on February 29, 2012 at 2:10 am

Michael Devereux
Chief Executive Officer
Schwabe North America, Inc.
825 Challenger Drive
Green Bay, Wisconsin 54311
 

Dear Mr. Devereux:

This letter is to advise you that the United States Food and Drug Administration (FDA or Agency) has reviewed your Schwabe North America, Inc. and Nature’s Way Products, Inc. websites at http://www.naturesway.com and http://www.umcka.com. FDA reviewed your firm’s labeling and marketing information for the “Umcka®” line of products including (but not limited to): ColdCare Original Drops, ColdCare Alcohol Free Drops, ColdCare Syrup (Mint-Menthol), ColdCare Syrup (Cherry), ColdCare Sugar-Free Syrup (Grape), ColdCare Soothing Hot Drink (Lemon), ColdCare Chewable (Mint-Menthol), ColdCare Chewable (Cherry), ColdCare FastActives™ Powder Packets (Cherry), ColdCare Children’s Syrup (Cherry), ColdCare Children’s FastActives™ Powder Packets (Cherry), Cold+Flu Syrup (Berry), Cold+Flu Syrup (Orange), Cold+Flu Chewable (Berry), Cold+Flu Chewable (Orange), and Cold+Flu FastActives™ Powder Packets (Berry) (collectively referred to as “Umcka products”). Based on our review of your websites and the labeling for these products, the Umcka products are unapproved new drugs in violation of sections 301 and 505 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. §§ 331 and 355). Further, the products are misbranded in violation of sections 301 and 503 of the Act(21 U.S.C. §§331 and 353).

Statements on your website http://www.umcka.com documenting the intended uses of the Umcka ColdCare line of products include, but are not limited to, the following:

“Umcka ColdCare is a 1X tincture of Pelargonium sidoides (EPs 7630), a medicinal plant unique to South Africa. In clinical studies, EPs 7630 not only relieves symptoms associated with common colds, but also shortens the duration and reduces severity of throat, sinus and bronchial irritations.”

“In an evaluation study, over 90% of patients and doctors rated EPs 7630 as an effective treatment for colds and upper respiratory irritations.”

“Umcka goes beyond symptom relief and actually helps you recover faster -which means you can get back to life faster, too.”

“The formula is a clinically proven preparation of EPs 7630, and the name [Umcka] is derived from the African word “umKhulkane” (meaning respiratory infection.)”

Statements on your website http://www.umcka.com documenting the intended uses of your Umcka Cold+Flu line of products include, but are not limited to, the following:

“Umcka Cold+Flu formulas combine two clinically-effective natural medicines (Umcka P. sidoides and the Alpha® CF blend) to tackle both cold and flu viruses.”

“Trust these products for maximum relief from:

• Aches/Pains
• Congestion
• Cough
• Fever
• Runny Nose
• Sore Throat

Statements on your website http://www.umcka.com and/or the labeling for your products that document the intended uses of the Umcka products include, but are not limited to, the following:

Umcka® ColdCare Chewable Tablets (Mint-Menthol):

“Umcka ColdCare

SHORTENS DURATION & REDUCES SEVERITY

Cough, Congestion, Sore Throat, Sinus & Bronchial Infections”

“You can feel confident knowing that the EPs 7630 found within Umcka has been widely studied by various clinical organizations in the treatment of the common cold, acute bronchitis and other upper respiratory concerns.”

Umcka® ColdCare Children’s Syrup (Cherry):

“A children’s liquid formula that shortens the duration and reduces the severity of throat, sinus, and bronchial irritations.”

Umcka® ColdCare Syrup (Cherry):

“Shortens duration and reduces severity of symptoms associated with common colds and throat/sinus/bronchial infections: congestion, cough, headache, hoarseness, minor aches, sore throat[.]

Helps loosen phlegm (mucus)to make cough more productive.”

Umcka® Cold+Flu Syrup (Orange):

“Umcka Cold+Flu

Multi-Action Natural Relief

Aches/Pains, Congestion, Cough, Fever, Runny Nose, Sore Throat”

“Shortens duration and reduces severity of symptoms associated with the common cold and throat/sinus/bronchial infections, and temporarily relieves flu symptoms:
 

• chills and fever
• congestion
• cough
• headache
• hoarseness
• minor aches/pains
• sore throat
• stuffy nose
• sneezing/runny nose
• helps loosen phlegm (mucus) to make coughs more productive.”

Further, your website http://www.umcka.com references published studies, and includes summaries of a number of published studies, on a page titled “Umcka® Product Research.” The publications listed on your website all concern therapeutic uses of Pelargonium sidoides, which is identified as an active ingredient in all of the Umcka® products. The page states “The Pelargonium sidoides extract (EPs 7630) within Umcka® has been widely studied by various clinical organizations to not only relieve symptoms associated with common colds, but also shortens the duration and reduces severity of throat, sinus and bronchial irritations.”

The following are examples of published clinical studies and summary statements included for them that are cited on your website in association with the Umcka products:

“Pelargonium sidoides preparation (EPs7630) in the treatment of acute bronchitis in adults and children.”

“In conclusion, EPs 7630 is an effective and well tolerated treatment of acute bronchitis in adults, children and infants outside the strict indication for antibiotic treatment.”

“Treatment of acute rhinosinusitis with the preparation from Pelargonium sidoides EPs 7630: a randomized, double-blind, placebo-controlled trial.”

“EPs 7630 was well tolerated and superior in efficacy compared to placebo in the treatment of acute rhinosinusitis of presumably bacterial origin.”
 

“Efficacy of extract of Pelargonium sidoides in children with acute non-group A beta-hemolytic streptococcus tonsillopharyngitis: a randomized double-blind, placebo controlled trial.”

“EPs 7630 was superior compared to placebo for the treatment of acute non-GABHS tonsillopharyngitis in children. Treatment with EPs 7630 reduced the severity of symptoms and shortened the duration of illness by at least 2 days.”

When scientific publications are used commercially by the seller of a product to promote the product to consumers, such publications may become evidence of the product’s intended use. For example, under 21 C.F.R. 101.93(g)(2)(iv)(C), a citation of a publication or reference in the labeling of a product is considered a claim about disease treatment or prevention if the citation refers to a disease use, and if, in the context of the labeling as a whole, the citation implies treatment or prevention of a disease.

 

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm292680.htm

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