- Delivery Method:
- UPS Overnight Delivery
Temple E. Palmer
- Celletech, Ltd
518 Tasman Street, Suite E
Madison, WI 53714-3100
- Issuing Office:
- Minneapolis District Office
| || |
Office of Human and Animal Foods - West Division 1
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
August 28, 2018
Via UPS Overnight Delivery Refer to CMS 525396
Temple E. Palmer
518 Tasman Street, Suite E
Madison, Wisconsin 53714-3100
Dear Mrs. Palmer:
Based on our review of your product labeling, including product labeling on your website which was most recently accessed in August 2018, as well as product labels collected during an inspection from January 31 through February 2, 2017, of your facility located at 518 Tasman Street, Suite E, Madison, Wisconsin, we identified serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable U.S. Food and Drug Administration (FDA) regulations. You can find the Act and FDA regulations through links on the FDA’s home page at http://www.fda.gov
Unapproved new human drugs
FDA reviewed your website at the Internet address http://celletech.com in November 2017 and has determined that you take orders there for the products Easy Breath and Winter Tonic Plus. In addition, FDA has reviewed product labels collected during the inspection. Although the labels for these products include the term “dietary supplement,” the claims on your website and on the labels collected during the inspection establish that the 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 cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act.
Examples of some of the website and product label claims that provide evidence that your products are intended for use as drugs include:
- The product label: “Easy Breath” along with the terms “BRONCH” and “ASTHM”
- Your website’s product page: a photo of a man clutching his upper chest with a distressed facial expression combined with “this product can help open breathing passages when they get constricted” and “Contains…asthma…”
Winter Tonic Plus
- Your website’s product page: “Celletech’s Homeotherapeutic Winter Tonic Plus is a proprietary combination of every ‘winter illness’ type from 1918 to the present. It is updated every year with the latest ‘winter illness type’. The combination of ‘winter illness’ types are combined with additional targeting agents that help your body adjust and respond to this year’s ‘winter illness’.”
- “This new Winter Tonic Plus includes KrebsCycle Acids that helps feed and stimulate the cells of the body to help deal with new ‘winter illnesses’ more efficiently.”
- “Winter Tonic Plus is more than one seasons flu vaccine, it is 94 years of different types of ‘Winter Illnesses’, (1918 through 2017/18) along with the European Winter Illness types called La grippe.”
- “For the last 20+ years Winter Tonic and Winter Balance II have been a great alternative to the Over-The-Counter products.”
- “As a preventative Winter Tonic Plus, along with Winter Balance II should be taken once a week during the winter season.”
- “If you become ill, Winter Tonic Plus, along with Winter Balance II should be taken 4 times a day until better.”
- “Winter Tonic Plus: 1918 ‘Winter Illness,’ Celletech Proprietary ‘Winter Illness’ combination, Otitis; Sinusitis; Grippe.”
- “Winter Tonic Plus helps your body mount a defense against the onslaught of ‘Winter Illnesses’, but it does not address the symptoms associated with the onslaught. Your body will respond more quickly and effectively to the ‘Winter Illnesses’, but you won't get the symptom relief that helps you adjust. Taken together, Winter Tonic Plus and Winter Balance II can provide symptomatic relief as well as a deep response. For the best defense, we recommend that both formulas be taken on a weekly basis during the ‘Winter Illness’ season, and that they be carried in purse or backpack so that they can be taken at the first signs that you have picked up a bug.”
These products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” under section 201(p) of the Act, 21 U.S.C. § 321(p). New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act, 21 U.S.C. §§ 331(d) and 355(a). FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.
The 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 requirements of federal law, including 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.
We acknowledge receipt of your February 17, 2017, response to the Form FDA-483 issued at the close of the inspection. You committed to cease the manufacturing of drug products at your facility by February 17, 2017, to submit a request to FDA to terminate your drug registration by February 17, 2017, to terminate the marketing of all drug products produced at Celletech, Ltd. by March 1, 2017, to remove API and destroy label stock and drug products in inventory by March 1, 2017, and to delete by April 1, 2017, all references to Celletech-produced drug products (the Kent and Allen brand) from your website. The effectiveness of these corrective actions will be evaluated in a future inspection.
Please respond to this office in writing within 15 working days from your receipt of this letter. In your response, identify the procedures you have taken or will take to completely correct the current violations and prevent similar ones. In your response please include the timeframe in which the corrections will be completed and provide documentation that will effectively assist us in evaluating whether the corrections have been made and their adequacy. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration. If you are unable to complete the corrective actions within 15 working days, identify the reason for the delay and the time within which you will complete the corrections.
Please send your reply to the Food and Drug Administration, Attention: Boun M. Xiong, Compliance Officer, at the address listed in the heading of this letter. If you have questions regarding any issue in this letter, please contact Mr. Xiong at (414) 326-3976.
Michael Dutcher, DVM
Director, West Division 1
Office of Human and Animal Food Operations