Company: Schwabe North America, Inc.
Subject: Unapproved New Drug/Misbranded
Issuer: Minneapolis District Office
Issued: Feb. 15, 2012 Closed:
Not Issued
Source ucm292680 Archive Code:

Schwabe North America, Inc. 2/15/12

Department of Health and Human Services

Public Health Service
Food and Drug Administration
Minneapolis District Office
Central Region
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone: (612) 334-4100
FAX: (612) 334-4142

February 15, 2012




Refer to MIN 12 -24

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 and 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 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 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 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


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 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.

Unapproved New Drugs [§§ 301(d) and 505(a)]

Based on the claims noted above for the mitigation or treatment of the common cold, flu, bronchitis, sinusitis, and rhinitis, as well as mitigation or treatment of the symptoms of the common cold, flu, bronchitis, sinusitis, and rhinitis, the Umcka products are drugs under section 201(g)(1)(B) of the Act (21 U.S.C. § 321 (g)(1)(B)), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man, and under section 201(g)(1)(C) of the Act (21 U.S.C. § 321(g)(1)(C)), because they are intended to affect the structure or any function of the body. We recognize that a number of the pages on your websites contain a disclaimer stating that the product is not intended to diagnose, treat, cure, or prevent any disease. However, notwithstanding this disclaimer, the claims made on your websites for the Umcka products clearly demonstrate that these products are drugs as defined by section 201 (g)(1) because they are intended for the treatment, mitigation, and/or prevention of disease, and/or to affect the structure or any function of the body of man.

Moreover, based on the active ingredients and the claims made for the Umcka products, they are new drugs within the meaning of section 201(P) of the Act (21 U.S.C. § 321(P)) because they are not generally recognized as safe and effective for their labeled uses. Drug products intended for indications such as those for which the Umcka products are labeled are subject to the final over-the-counter (OTC) drug monograph for "Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products" (OTC Cough/Cold Final Monograph). See 21 C.F.R. Part 341. This final monograph does not include any of the active ingredients in the Umcka products, nor were the active .ingredients in the Umcka products evaluated as part of the OTC drug review for any use, including any of the indications found in the labeling for the Umcka products. 1 Furthermore, indications for treatment of bronchitis, rhinositis, and non-group A beta-hemolytic streptococcus tonsillopharyngitis are not included in the OTC Cough/Cold Final Monograph. Additionally, we are not aware of a product with these ingredients, to treat any of the intended uses of the Umcka products, having been available in the U.S. market as an OTC drug on or before the inception of the OTC drug review. Accordingly, the Umcka products are not subject to the OTC drug review.

Under sections 301(d) and 505(a) of the Act (21 U.S.C. §§ 331(d) and 355(a)), a new drug may not be introduced or delivered for introduction into interstate commerce unless an application approved by FDA under either section 505(b) or (j) of the Act (21 U.S.C. §§ 355(b) or (j)) is in effect for the product. Based upon our information, there are no FDA approved applications on file for the above products. Therefore, the marketing of the Umcka products without approved applications constitutes a violation of these provisions of the Act.

We recognize that these products are identified as homeopathic drugs with active ingredients measured in homeopathic strengths. 2 The definition of"drug" in section 201(g)(1) of the Act (21 U.S.C. § 321(g)(1)) includes articles recognized in the official Homeopathic Pharmacopeia of the United States (HPUS), or any supplement to it. Homeopathic drugs are subject to the same regulatory requirements as other drugs; nothing in the Act exempts homeopathic drugs from any of the requirements related to adulteration, labeling, misbranding, or approval. We acknowledge that many homeopathic drugs are manufactured and distributed without FDA approval under enforcement policies set out in the Agency's Compliance Policy Guide titled "Conditions Under Which Homeopathic Drugs May be Marketed (CPG 7132.15)" (the CPG). As its title suggests, the CPG identifies specific conditions under which homeopathic drugs may ordinarily be marketed; thus, in order to fall under the enforcement policies set forth in the CPG, a homeopathic product must meet the conditions set forth in the CPG. The CPG defines a homeopathic drug as "Any drug labeled as being homeopathic which is listed in the Homeopathic Pharmacopeia of the United States (HPUS), an addendum to it, or its supplements." The CPG additionally states that "Drug products containing homeopathic ingredients in combination with non-homeopathic active ingredients are not homeopathic drug products."

Although Aconitum napellus, Bryonia alba, Eucalyptus globulus, Eupatorium perfoliatum, Gelsemium sempervirens, Ipecacuanha, and Phosphorus are all recognized homeopathic ingredients included in the HPUS, Pelargonium sidoides is not included in the HPUS or any of its addenda or supplements. Furthermore, to our knowledge, Pelargonium sidoides is not listed in any recognized materia medica containing information on the preparation of homeopathic medicines. Therefore, Pelargonium sidoides is not a homeopathic ingredient and the Umcka products are not considered homeopathic drug products under the CPG. Accordingly, the policies set forth in the CPG for the marketing of homeopathic drug products do not apply to the Umcka products.

Misbranding [§§ 503(b)(4) and 301(a)]

As stated above, publications listed on your website discuss therapeutic uses of pelargonium sidoides, the active ingredient of all Umcka products, including use for treatment of acute bronchitis in adults and children, treatment of acute rhinosinusitis, and treatment of acute non-GABHS tonsillopharyngitis in children. Section 503(b)(1) of the Act (21 U.S.C. § 353(b)(1)) identifies criteria for determining the prescription status of a product. The Umcka products are prescription drugs within the meaning of section 503(b)(1) of the Act. The publications on your website summarize the results of the studies of the active ingredient (pelargonium sidoides) in all the Umcka products. Based on these studies, the Umcka products are intended to treat diseases that require diagnosis and treatment by a physician or are intended to provide treatment for symptoms usually caused by an underlying disease process that requires diagnosis and treatment by a physician. Because prescription drugs may be dispensed only by prescription of a licensed practitioner, these products are misbranded under section 503(b)(4) of the Act (21 U.S.C. § 353(b)(4)) in that their labels fail to bear the symbol "Rx only." Your marketing of these misbranded products violates section 301(a) of the Act (21 U.S.C. § 331(a)).

The issues and violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all applicable requirements of federal law and FDA regulations.

You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction. Other federal agencies may take this Warning Letter into account when considering the award of contracts.

Within 15 working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct the violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will complete the corrections. Furthermore, please advise this office of what actions you will take to address product(s) that you have already distributed.

Address your reply to the U.S. Food and Drug Administration, Attention: Tyra S. Wisecup, Compliance Officer, at the above letterhead address. If you have any questions, please contact Ms. Wisecup at (612) 758-7114.

Joann M. Givens
Acting District Director
Minneapolis District Office

1 We acknowledge that homeopathic drug products were excluded from the OTC drug review. 37 F.R. 9464, 9466 (May 11, 1972). However, as discussed below, FDA does not consider your Umcka products to be homeopathic drug products.

2 For example, the label for ColdCare® FastActives™ Powder Packets (Mint-Methol) includes the ingredient "Pelargonium sidoides 1X".