Omega Wonders LLC.
FDA issued a warning letter to Omega Wonders LLC (Bonita Springs, FL) regarding its Cardia 7 Heart Health OMEGA 7 and Advanced Tear Health OMEGA 7 dietary supplement products. The agency found that website and Amazon marketing claims — including statements about reducing cholesterol, fighting inflammation, managing dry eye symptoms, and targeting atherosclerosis and diabetes — rendered the products unapproved new drugs under the FD&C Act. FDA also determined the products were misbranded for lacking adequate directions for use, and warned that failure to correct violations could result in seizure or injunction.
Flagged claims (13)
Cardia 7 Omega 7 helps support healthy LDL/HDL cholesterol levels …
Omega 7 is a naturally-occurring monosaturated fatty acid that has . . . beneficial effects in dealing with insulin resistance, obesity and cardiovascular complications.
Ideal for cholesterol, cardiovascular, diabetes. . .
PURIFIED OMEGA-7 IN THE FIGHT AGAINST ATHEROSCLEROSIS
MANAGE DRY EYE SYMPTOMS: TearHealth has been shown to manage dry eye symptoms by increasing tear production, reducing tear evaporation, and improving tear quality.
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 . . .
[O]mega 7 (palmitoleic acid) can potentially help in the fight against diabetes . . . and atherosclerosis.
. . . contains Provinal, a concentrated source of omega-7 fatty acids with inflammation-fighting properties . . .
Our formula can help relieve dry eyes and deliver necessary eye nutrition. . .
Purified Omega 7 nutritional supplements offer targeted support for healthy cholesterol levels . . . and c-reactive protein (CRP) levels, an important marker for inflammation.
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 . . .
TearHealth™ has been shown to manage dry eye symptoms by increasing tear production, reducing tear evaporation and improving tear quality.
Manage Dry Eye Symptoms – Increase Tear Production and Soothe Irritation
Required actions (2)
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.
Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
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