WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED   

Refer to MIN 11 - 10

Ken Evenstad
Chairman/Chief Executive Officer
Upsher Smith Laboratories, Inc.
6701 Evenstad Drive
Maple Grove, Minnesota  55369

Dear Mr. Evenstad:

This is to advise you that the United States Food and Drug Administration (FDA) has reviewed your website at the Internet address http://www.slo-niacin.com/¹ and has determined that your SLO-NIACIN® product is promoted for conditions that cause the product to be a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(g)(1)(B). The therapeutic claims on your website establish that the product is a drug because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.  The marketing of this product with these claims violates the Act.  You may find the Act and the FDA's regulations through links on FDA's home page at http://www.fda.gov/².

Examples of some of the claims observed on your website include:

• "SLO-NIACIN.Reduced risk of cardiovascular events* when combined with a statin."
• "SLO-NIACIN.Halted stenosis progression when combined with a statin."
• "Niacin is clinically proven to help manage cholesterol levels, a major factor in heart health.
• "SLO-NIACIN® Offers an affordable option for Cholesterol Management.
• "[N]iacin is the oldest of today's commonly used agents for lowering cholesterol."
• "See how.niacin complements statin therapy for heart health."

Furthermore, the "References" and "In the News" sections of your website for this product cite a number of articles about the usefulness of the ingredient niacin in treating and preventing diseases.  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 CFR 101.93(g)(2)(iv)(C), a citation of a publication or reference in the labeling of a product is considered to be 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.  The following are examples of reference citations used to market your product for disease treatment and prevention on your website:

1.  "Lavie CJ, Mailander L, Milani.  Marked benefit with sustained-release niacin therapy in patients with ?isolated' very low levels of high-density lipoprotein cholesterol and coronary artery disease.  Am J Cardiol.  1992; 69:1083-1085."
2.  "Gray DR, Morgan T, Chretien SD, Kashyap ML.  Efficacy and Safety of Controlled-Release Niacin in Dyslipoproteinemic Veterans.  Ann Intern Med. 1994; 121:252-258."
3. "Brown BG, Zhao XQ, Chait A, et al.  Simvastatin and niacin, antioxidant vitamins, or the combination for the prevention of coronary disease.  N Engl J Med. 2001; 345(22):1583-1592."
4. "Knopp RH, Retzlaff BM, Fish B, et al.  The SLIM study: Slo-Niacin and atorvastatin treatment of lipoproteins and inflammatory markers in combined hyperlipidemia.  J Clin Lipidol.  2009; 3(3):167-178."

Your product is not generally recognized as safe and effective for the above referenced uses and therefore the product is a new drug as defined in section 201(p) of the Act, 21 U.S.C. § 321(p). Under section 505(a) of the Act, 21 U.S.C. § 355(a), a new drug may not be legally marketed in the United States without prior approval from FDA.  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. Your SLO-NIACIN product is also misbranded within the meaning of section 502(f)(1) of the Act in that the labeling for this drug fails to bear adequate directions for use, 21 U.S.C. § 352(f)(1).

The above violations are not meant to be an all-inclusive list of deficiencies in your product and its labeling.  It is your responsibility to ensure that products marketed by your firm comply with the Act and its implementing regulations. You should take prompt action to correct the violations described above and prevent their future recurrence. Failure to do so may result in enforcement action without further notice.  The Act authorizes the seizure of illegal products and injunction against manufacturers and distributors of those products, 21 U.S.C. §§ 332 and 334.

We note that you provide several images on your website at the Internet address http://www.slo-niacin.com/³.  Under 21 CFR 101.93(g)(2)(iv)(E), an image may be considered as a claim to diagnose, mitigate, treat, cure, or prevent disease if in the context of the labeling it suggests that the product has an effect on a disease or diseases.

Please respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific actions you are taking to correct these violations and to ensure similar violations do not occur. You should include in your response documentation such as revised labeling or other useful information that would assist us in evaluating your corrections.  If you cannot complete all corrections within 15 working days, state the reason for the delay and the time frame within which any remaining violations will be completed.

Your written response should be directed to the U.S. Food and Drug Administration, Attention: Tyra S. Wisecup, Compliance Officer, at the address listed in the letterhead.  If you have questions regarding any issues in this letter, please contact Ms. Wisecup at (612) 758-7114.

Sincerely, 

 

/S/

Gerald J. Berg
Director
Minneapolis District