Inspections, Compliance, Enforcement, and Criminal Investigations
Agora Publishing Inc 1/10/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Baltimore District Office|
6000 Metro Drive
Baltimore, MD 21201-2199
Telephone: (410) 779-5455
FAX: (410) 779-5705
January 10, 2012
RETURN RECEIPT REQUESTED
Myles Norin, CEO
14 West Mount Vernon Place
Baltimore, MD 21201
Re: CMS #210473
Dear Mr. Norin:
This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at www.northstamutritionals.com in December 2011 and has determined that your products "PureImmune Plus" and "Healthy Aging" are promoted for conditions that cause the products to be drugs 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 these products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of your products with these claims violates the Act. You can find the Act and its implementing regulations through links at FDA's home page at http://www.fda.gov.
Examples of some of the claims observed on your website include:
On the webpage entitled, "PureImmune Plus":
• "If you could take one easy step to help prevent your greatest fear wouldn't you take it? Stop living in fear of CANCER"
• "If you're "in the know" you may already know that selenium [an ingredient in the product] is helping us turn the corner in cancer protection."
• "Key to protecting you against cancer's deadly tricks before they start ... Anyone of selenium's [an ingredient in the product] following weapons could explain a positive effect on cancer protection. Studies suggest that . .. it impacts genes that are linked to the progression of cancer"
• "[I]t's [Epicor®, an ingredient in the product] free radical--fighting powers may actually have some natural anti-inflammatory properties ...."
On the webpage titled, "Healthy Aging":
• "Keeping your blood sugar in balance helps slow glycation - sugar eating away at your nerve and sensory cells."
• "Alpha Lipoic Acid (ALA) [an ingredient in the product] ... Studies show it improves insulin sensitivity, making it easier for your blood sugar to stay stable."
• "Chromium. [an ingredient in the product] Not just for supporting healthy blood sugar, Chromium may also help maintain glucose tolerance ...."
• "They're saying it [green tea, an ingredient in this product] can improve cholesterol."
• "And the proanthocyanidins in Leucoselect® [an ingredient in the product] have been shown to help folks fend off all kinds of blood vessel problems --from peripheral venous insufficiency (a big cause of leg pain) to ...."
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 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.
Furthermore, these products are misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] in that the labeling for these drugs fails to bear adequate directions for use. Because these products are intended for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written for them so that a layperson can use them safely for their intended uses. The introduction of a misbranded drug into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C.§331(a)].
This letter is not meant to be an all-inclusive list of violations in your products and their labeling. It is your responsibility to ensure that products marketed by your firm comply with the Act and its implementing regulations. We advise you to review your website, product labels, and other labeling and promotional materials for your products to ensure that the claims you make for your products do not cause them to violate the Act. You should take prompt action to correct the violations described above and prevent their future recurrence. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction
Please notify this office in writing within fifteen (15) working days from your receipt of this letter as to the specific steps you have taken to correct the violations noted above and to assure 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, please explain the reason for the delay and state the date by which the corrections will be completed.
Please send your reply to the attention of CDR Rochelle B. Young, Compliance Officer, Food and Drug Administration, 6000 Metro Drive, Suite 101, Baltimore, Maryland 21215. If you have any questions regarding any issue in this letter, please contact CDR Young at 410-779-5437.