Department of Health and Human Services
|Public Health Service
Food and Drug Administration
Minneapolis District Office
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone: (612) 758-7114
FAX: (612) 334-4142
November 20, 2009
RETURN RECEIPT REQUESTED
Refer to MIN 10 - 05
Andrew J. Baechler
Owner and CEO
Wellspring International, Inc.
One Eniva Way
Anoka, Minnesota 55303
Dear Mr. Baechler:
An inspection of your facility located at One Eniva Way, Anoka, Minnesota, was conducted by investigators from the Food and Drug Administration (FDA) on September 1, 8, 10 and 11, 2009. During this inspection we obtained and subsequently reviewed the label and labeling of your Cholesterol Reducer Dietary Supplement. FDA's review found that your product is promoted with claims which cause it to be an unapproved new drug within the meaning of section 505 of the Act (21 U.S.C. § 355) and is therefore in violation of the Federal Food, Drug, and Cosmetic Act (the Act) and the applicable regulations in Title 21, Code of Federal Regulations (21 CFR). You can find copies of the Act and these regulations through links in FDA's home page at http://www.fda.gov.
Unapproved New Drug:
The claims made on your product's label establish that your Cholesterol Reducer Dietary Supplement is a drug because it is intended for use in the prevention, mitigation, and treatment of disease. Examples of some of the claims observed on your Cholesterol Reducer product label or promotional brochures include:
- "Eniva Cholesterol Reducer"
- "The Eniva Cholesterol Reducer nutraceutical is a high specialized dietary supplement designated to address unhealthy substances associated with heart and blood vessel challenges - Cholesterol and Homocysteine. This nutraceutical promotes a reduction in cholesterol** This formula also supports healthy homocysteine levels."
- "Use the Eniva Cholesterol Reducer™ to help achieve a healthy cholesterol level in just 8 weeks!"
- "Naturally Lower Your Cholesterol* Up to 15% in 8 weeks"
- "Specialized ingredients in a liquid formula can safely and naturally lower cholesterol."
- "Homocysteine is an amino acid that can act like 'grit' in blood vessels causing damage and contributing to unwanted cholesterol build-up."
- "Eniva Cholesterol Reducer ingredients promote healthy homocysteine levels by helping convert homocysteine to blood vessel friendly substances."
- "Enhanced liquid formula may reduce your risk of heart challenges."
- "A Safe Choice for Healthy Cholesterol*"
Your product is not generally recognized as safe and effective for the above referenced uses and, therefore, the product is a new drug under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective for its intended use.
We acknowledge your letter of September 22, 2009, and the corrections promised therein. However, the corrections made to the submitted revised labels do not correct all of the noted violations. Additionally, you did not state when the new labels and labeling would be in use, nor the disposition of the remaining label and labeling stock.
This letter is not an all-inclusive list of violations at your facility. It is your responsibility to ensure that your establishment and the products you market comply with the Act and its implementing regulations.
Failure to promptly correct the violations specified above may result in enforcement action without further notice. Enforcement action may include seizure of violative products and/or injunction against the manufacturers and distributors of violative products.
Please advise this office in writing within 15 days from your receipt of this letter of the specific steps you have taken to correct the violations noted above and to ensure that similar violations do not occur. Your response should include any documentation necessary to show that correction has been achieved. If you cannot complete all corrections before you respond, state the reason for the delay and the date by which you will complete the corrections.
Please send your reply to the attention of Tyra S. Wisecup, Compliance Officer, at the address in the letterhead. If you have any questions regarding this letter, please contact Ms. Wisecup at (612) 758-7114.
W. Charles Becoat
This page was posted on January 31, 2010.