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  5. Omega Wonders LLC. - 613279 - 05/26/2021
  1. Warning Letters

WARNING LETTER

Omega Wonders LLC. MARCS-CMS 613279 —


Delivery Method:
VIA Electronic Mail
Reference #:
21-HAFE4-WL-05
Product:
Dietary Supplements

Recipient:
Recipient Name
Mr. Timothy Gooding
Recipient Title
Manager
Omega Wonders LLC.

8000 Health Center Blvd.
Unit 100
Bonita Springs, FL 33145
United States

info@omegawonders.com
Issuing Office:
Office of Human and Animal Food Operations East Division IV

United States


Dear Mr. Gooding:

This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address https://www.omegawonders.com/ in March and May 2021 and has determined that you take orders there for the products Cardia 7 Heart Health OMEGA 7 and Advanced Tear Health OMEGA 7. In addition, FDA reviewed your website at https://tersuslifesciences.com/, which directs consumers to https://www.omegawonders.com/ to purchase your products, and reviewed the webpages for your Cardia 7 Heart Health OMEGA 7 and Advanced Tear Health OMEGA 7 products at www.amazon.com. The claims on your websites establish that these 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 FDA’s home page at www.fda.gov.

Examples of some of the website claims that provide evidence that your products are intended for use as drugs include:

Cardia 7 Heart Health Omega 7 / Cardia 7 Purified Omega 7 Softgels – 60 Count

On the product webpage at https:/www.omegawonders.com/
• “Cardia 7 Omega 7 helps support healthy LDL/HDL cholesterol levels …”
• “Purified Omega 7 nutritional supplements offer targeted support for healthy cholesterol levels . . . and c-reactive protein (CRP) levels, an important marker for inflammation.”

Your website also contains evidence of intended use in the form of personal testimonials recommending or describing the use of this product for the cure, mitigation, treatment, or prevention of disease. Examples of such testimonials include:
• “Reduced my LDL . . .” (Feb 09, 2015 by Tom)
• “Cardia 7 and familial hypercholesterolemia . . . CRP normalized in patient with FH. Cardia 7 excelled where statins . . . did not.” (Dec 22, 2014 by Physician in Alabama)
• “I have been taking cardia7 for almost a year and my total cholesterol has already normalized without taking any Mevacor . . . My . . . ldl, hdl, vldl are also normal.” (May 16, 2014 by pierre lepoureau)
• “LOWER BLOOD PRESSURE . . .Cardia 7 is great for lowering my BP . . .” (April 11, 2014 by Pat)
• “I was on Cardia 7 . . . my cholesterol . . . and glucose have all gone down to normal.” (Feb 23, 2014 by Sau Wan Chun)
• “I am a type 2 diabetic . . . all my blood levels have improved.” (Feb 21, 2014 by Anton R. Simon)

On your product webpage for Cardia 7 Heart Health Omega 7 – 30 Count at https://www.amazon.com/stores/Cardia+7/page/20267E97-CC23-4EB6-B2A3-F57FC876564C?ref_=ast_bln
• “. . . contains Provinal, a concentrated source of omega-7 fatty acids with inflammation-fighting properties . . .”

On the webpage for Purified Omega 7 [described as a component of your product] at https://tersuslifesciences.com/
• “Ideal for cholesterol, cardiovascular, diabetes. . .”
• “PURIFIED OMEGA-7 IN THE FIGHT AGAINST ATHEROSCLEROSIS”
• “Breakthrough’ Health Supplement Targets Chronic Inflammation and C-Reactive Protein (CRP) Levels[-] Cardia 7 is a purified Omega 7 supplement that has been clinically shown to reduce C-reactive protein (CRP) levels and chronic inflammation — the best predictor of heart disease . . .”
• “This is exciting news because Purified Omega 7 ‘antagonizes’ all three because it has been shown to decrease insulin resistance . . . and decrease acute and chronic inflammation . . . ”

On the webpage for Provinal® (“About Provinal® Purified Omega 7”) [described as a component of your product] at https://tersuslifesciences.com/provinal/
• “Omega 7 is a naturally-occurring monosaturated fatty acid that has . . . beneficial effects in dealing with insulin resistance, obesity and cardiovascular complications.”

On the webpage: https://tersuslifesciences.com/news/
• “[O]mega 7 (palmitoleic acid) can potentially help in the fight against diabetes . . . and atherosclerosis.”

Advanced Tear Health Omega 7 / Tear Health TM Eye Health Support- 60 count

On your product webpage at https://www.omegawonders.com/:
• “TearHealth™ has been shown to manage dry eye symptoms by increasing tear production, reducing tear evaporation and improving tear quality.” On your product webpage at https://www.amazon.com/Cardia-TearHealth-All-Natural-Production-Irritation/dp/B08C4SYZSW/ref=sr_1_5?dchild=1&keywords=advanced+tear+health+omega+7&qid=1617830688&sr=8-5
• “. . . Manage Dry Eye Symptoms – Increase Tear Production and Soothe Irritation”
• “MANAGE DRY EYE SYMPTOMS: TearHealth has been shown to manage dry eye symptoms by increasing tear production, reducing tear evaporation, and improving tear quality.”
• “Our formula can help relieve dry eyes and deliver necessary eye nutrition. . .”
• “. . . get the essential Omega-7s to . . . manage dry eye symptoms.”
• “Increase Tear Production”

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)]. With certain exceptions not applicable here, 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), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating 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 Cardia 7 Heart Health OMEGA 7 and Advanced Tear Health OMEGA 7 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 Cardia 7 Heart Health OMEGA 7 and Advanced Tear Health OMEGA 7 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)].

This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations 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 FDA regulations.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.

Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any 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 actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.

Your written response should be directed to the Food and Drug Administration, Attention to: Mr. Ramon Hernández, District Director, 466 Fernández Juncos Avenue, San Juan, Puerto Rico 00901-3223. If you have any questions regarding this letter, please contact Ms. Beira Montalvo, Compliance Officer, at (561) 416-1065 ext. 1108 or via e-mail at Beira.Montalvo@fda.hhs.gov.


Sincerely,
/S/
Ramon A. Hernandez
Director, San Juan District Office
Program Division Director
Office of Human and Animal Food Operations,
Division IV East

 
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