WARNING LETTER
Wellness Resources, Inc. MARCS-CMS 537216 —
- Delivery Method:
- UPS
- Recipient:
-
Recipient NameMary Guignon
- Wellness Resources, Inc.
7155 Amundson Avenue
Edina, MN 55439-2020
United States
- Issuing Office:
- Minneapolis District Office
United States
Office of Human and Animal Foods - West Division 1 | |
November 30, 2017
WARNING LETTER
Via UPS Overnight Delivery Refer to CMS 537216
Mary Guignon, Owner and CEO
Ryan J. Richards, General Manager
Wellness Resources, Inc.
7155 Amundson Avenue
Edina, Minnesota 55439-2020
Wellness Resources, Inc.
7155 Amundson Avenue
Edina, Minnesota 55439-2020
Dear Ms. Guignon and Mr. Richards:
This is to advise you that the Food and Drug Administration (FDA) reviewed your website at www.wellnessresources.com in July 2017 and has determined that you take orders there for your DHA Daily, DHA Kids, Lipnital, and Green Tea Extract products. The claims on your website establish that the products are 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), 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. You can find the Act and FDA regulations through links on the FDA’s home page at www.fda.gov.
Examples of some of the claims that provide evidence that these products are intended for use as drugs include:
On your page entitled “Fish Oil Helps Prevent Osteoarthritis”:
- “New research has shown for the first time that omega-3 in fish oil (DHA/EPA) [an ingredient in your DHA Daily, DHA Kids, and Lepnital] could substantially and significantly reduce the signs and symptoms of osteoarthritis. There was strong evidence that omega-3 influences the biochemistry of the disease, and therefore not only helps prevent disease, but also slows its progression, potentially controlling established osteoarthritis….”
On your page entitled “DHA in the War on Cancer” (DHA is an ingredient in your DHA Daily, DHA Kids, and Lepnital products):
- “Scientists have just discovered that DHA is a potent anti-cancer compound.”
“[I]f DHA enters a nerve cell that has turned cancerous it now appears that DHA will act to kill the cancer.”
“[S]cientists believe that their discovery may lead to new treatments for a wide range of cancers, including neuroblastoma, medulloblastoma, colon, breast, and prostate cancers, among others.”
On your page entitled “Green Tea Extract Helps Patients with Chronic Lymphocytic Leukemia” (Green Tea Extract is an ingredient in your Green Tea Extract product):
- “[T]he biologically active extract of green tea…slows down cancer in patients with chronic lymphocytic leukemia.”
“EGCG, like many other anti-cancer nutrients and unlike most toxic cancer drugs, has the ability to protect healthy cells while killing cancer cells.”
“[A]s well as studies showing that it can also help prevent stroke as well as the amount of damage from stroke.”
Your 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 submitted by a drug sponsor to demonstrate that the drug is safe and effective.
A drug is misbranded under section 502(f)(1) of the Act, 21 U.S.C. § 352(f)(1), if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act, 21 U.S.C. § 353(b)(1)(A), can only be used safely at the direction, and under the supervision, of a licensed practitioner.
Your products are intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, your DHA Daily, DHA Kids, Lipnital, and Green Tea Extract products fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the Act, 21 U.S.C. § 352(f)(1). The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act, 21 U.S.C. § 331(a).
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 the Act and its implementing 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.
Within 15 working days of your receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will complete the corrections.
Please send your written reply to Boun M. Xiong, Compliance Officer, Food and Drug Administration, at the address on the letterhead. If you have questions about this letter, please contact Mr. Xiong at (414) 326-3976.
/S/
Michael Dutcher, DVM
Director, Division West 1
Office of Human and Animal Foods Operations