Inspections, Compliance, Enforcement, and Criminal Investigations
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|5100 Paint Branch Parkway
College Park, MD 20740
TO: firstname.lastname@example.org, email@example.com
Master Supplements, Inc.
1600 Arboretum Blvd., Suite 202
P.O. Box 240
Victoria, MN 55386
Vice President of Sales and Marketing
P.O. Box 633
Dalton, PA 18414
FROM: Food and Drug Administration
RE: Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus
DATE: JUL 16 2009
This is to advise you that the United States Food and Drug Administration (FDA) reviewed your websites at the Internet addresses
http://www.acidophilus-immune-health.com and http://www.master-supplements.com on 7/13/09. The FDA has determined that your websites, together, offer a product for sale that is intended to diagnose, mitigate, prevent, treat, or cure the H1N1 Flu Virus in people, as evidenced by claims on http://www.acidophilus-immune-health.com.This product has not been approved, cleared, or otherwise authorized by FDA for use in the diagnosis, mitigation, prevention, treatment, or cure of the H1N1 Flu Virus. This product is Theralac. The marketing of this product violates the Federal Food, Drug, and Cosmetic Act (FFDC Act). 21 U.S.C. §§ 331,351, 352. We request that you immediately cease marketing unapproved, uncleared, or unauthorized products for the diagnosis, mitigation, prevention, treatment, or cure of the H1N1 Flu Virus.
Some examples of the claims on http://www.acidophilus-immune-health.com include:
o "The saying goes 'an ounce of prevention is worth a pound of the cure'. Probiotics such as Theralac® are a very affordable 'ounce of prevention'. An up-regulated immune system is a healthy immune system. Order Theralac now.... Get one bottle to take ongoing and one to keep on hand if Swine Flu turns pandemic."
o "Dr. Allen S. Josephs, M.D. in an article 'Guard Yourself Against the Deadly Avian Flu Now' ... discusses various dietary supplements that can help fight the Avian and Swine Flu epidemics that may be around the corner. He places emphasis on supplements such as PROBIOTICS that enhance the immune system."
Clicking on the picture of the bottle of Theralac next to the first quoted claim from http://www.acidophilus-immune-health.com takes the consumer directly to your website at http://www.master-supplements.com. where the product is available for purchase.
The Secretary of Health and Human Services, under section 319 of the Public Health Service Act, 42 U.S.C. § 247d, has determined that a public health emergency exists nationwide involving the H1N1 Flu Virus that affects or has the significant potential to affect national security. Following this determination and in response to requests from the U.S. Centers for Disease Control and Prevention, FDA issued letters authorizing the emergency use of certain unapproved and uncleared products or unapproved or uncleared uses of approved or cleared products, provided certain criteria are met, under 21 U.S.C. § 360bbb-3. The marketing and sale of unapproved or uncleared H1N1 Flu Virus related products that are not authorized by and used in accordance with the conditions of an Emergency Use Authorization, is a potentially significant threat to the public health. Therefore, FDA is taking urgent measures to protect consumers from products that, without approval or authorization by FDA, claim to diagnose, mitigate, prevent, treat or cure H1N1 Flu Virus in people.
You should take immediate action to ensure that your firm is not marketing, and does not market in the future, products intended to diagnose, mitigate, prevent, treat or cure the H1N1 Flu Virus that have not been approved, cleared, or authorized by the FDA. The above is not meant to be an all-inclusive list of violations. It is your responsibility to ensure that the products you market are in compliance with the FFDC Act and FDA's implementing regulations. We advise you to review your websites, product labels, and other labeling and promotional materials to ensure that the claims you make for your products do not adulterate or misbrand the products in violation of the FFDC Act. 21 U.S.C. §§ 331, 351, 352. Within 48 hours, please send an email to FDAFLUTASKFORCECFSAN@fda.hhs.gov, describing the actions that you have taken or plan to take to address your firm's violations. If your firm fails to take corrective action immediately, FDA may take enforcement action, such as seizure or injunction for violations of the FFDC Act without further notice. Firms that fail to take corrective action may also be referred to FDA's Office of Criminal Investigations for possible criminal prosecution for violations of the FFDC Act and other federal laws.
FDA is advising consumers not to purchase or use H1N1 Flu Virus-related products offered for sale that have not been approved, cleared, or authorized by FDA. Your firm will be added to a published list on FDA's website of firms and websites that have received warning letters from FDA concerning marketing unapproved, uncleared, and unauthorized H1N1 Flu Virus-related products in violation of the FFDC Act. This list can be found at www.accessdata.fda.gov/scripts/h1n1flu. Once the violative claims and/or products have been removed from your website, and these corrective actions have been confirmed by the FDA, the published list will be updated to indicate that your firm has taken appropriate corrective action.
If you are not located in the United States, please note that unapproved, uncleared, or unauthorized products intended to diagnose, mitigate, prevent, treat, or cure the H1N1 Flu Virus offered for importation into the United States are subject to detention and refusal of admission. We will advise the appropriate regulatory or law enforcement officials in the country from which you operate that FDA considers your product listed above to be unapproved, uncleared, or unauthorized product that cannot be legally sold to consumers in the United States.
Please direct any inquiries concerning this letter to FDA at FDAFLUTASKFORCECFSAN@fda.hhs.gov or by contacting Felicia Binion Williams at 301-436-2566.
Roberta F. Wagner
Office of Compliance
Center for Food Safety
And Applied Nutrition