Who Owns Omega XL: Great HealthWorks, FDA Warnings, Billing

Omega XL is owned by Great HealthWorks, Inc., a privately held direct-to-consumer health and wellness company headquartered in Fort Lauderdale, Florida. The company was founded in 2003 by Ken Meares, who still serves as Executive Chairman, and employs roughly 255 people in the United States. Omega XL is its flagship product and the one that drives most of its national television advertising.

Who Runs Great HealthWorks

Ken Meares founded the company after identifying a market among aging baby boomers interested in joint health, built the Omega XL brand around New Zealand green-lipped mussel oil, and shaped the business around direct-response television marketing rather than retail distribution. He no longer holds the CEO title. Day-to-day operations are run by Andrew LaBarbera as Chief Executive Officer, and Dr. Sharon McQuillan serves as Chief Science Officer.1Great HealthWorks. About Us – Section: Executive Leadership

Because the company is privately held, the Meares family retains equity that would otherwise be distributed to public shareholders. That gives leadership the ability to make strategic decisions without answering to outside investors or quarterly earnings pressure.

Corporate Structure and Headquarters

Great HealthWorks lists its principal address as 4150 SW 28th Way, Fort Lauderdale, Florida 33312, which serves as both its corporate headquarters and distribution center. Florida’s Division of Corporations classifies it as a Foreign Profit Corporation, meaning it was incorporated in another state and registered in Florida to do business there. Its registered agent for legal service is Northwest Registered Agent LLC, based in St. Petersburg.2Florida Division of Corporations. Detail by Entity Name

The company describes itself as one of the largest vertically integrated direct-to-consumer health firms in the country, controlling manufacturing, marketing, and fulfillment rather than selling through Amazon, pharmacy chains, or health food stores.3Great HealthWorks. About Us Its brand portfolio has grown to include a family of products under the XL name and a women’s health and beauty line called NEW YOU, but Omega XL remains the revenue driver.

Because the company is not publicly traded, it is not required to publish annual revenue figures, profit margins, or detailed financial statements. Its financial health and internal operations are largely opaque to consumers.

FDA Warning Letters Against the Company

In June 2021, the FDA issued a warning letter to Great HealthWorks stating that Omega XL was being marketed as an unapproved new drug. The agency found that the company’s website made claims about treating or relieving joint pain due to inflammation, which crossed the line from permissible supplement marketing into drug-level claims that require FDA approval.4U.S. Food and Drug Administration. Great Healthworks, Inc. – 611686 – 06/23/2021 Language the FDA flagged included claims like “shown to help relieve joint pain due to inflammation” and references to an “89% improvement in joint discomfort.”

The FDA followed up in January 2022, evaluating the company’s corrective actions in response to the original letter.5U.S. Food and Drug Administration. Great Healthworks, Inc. – 611686 – 01/25/2022 A dietary supplement can legally say it “supports” joint health, but it cannot claim to treat, cure, or relieve a medical condition without going through the drug approval process.

Subscription Billing and Consumer Complaints

Omega XL is sold primarily through a subscription-based autoship program. When consumers call the number in television ads, the sales pitch typically includes a promotional price on the first order followed by automatic monthly shipments at a higher recurring price. Complaint records show recurring charges in the range of roughly $85 to $90 per month.

The Better Business Bureau’s profile for Great HealthWorks shows 111 complaints filed over a three-year period, with billing disputes forming a notable category. Common patterns include consumers who say they were not clearly told they were signing up for recurring charges, and customers who report being charged for shipments they say never arrived but are still told to return the product before receiving a refund.

A class-action lawsuit filed in 2017 in the Southern District of California alleged that the company deceptively enrolled customers in automatic subscriptions without adequate disclosure. The case was voluntarily dismissed without prejudice in March 2018, meaning it could have been refiled but never was. No public settlement was announced.

If you are considering ordering Omega XL, ask explicitly whether you are signing up for recurring shipments, and get the cancellation terms in writing before you provide payment information.

What FDA Registration Does and Does Not Mean

Like all companies that manufacture or distribute dietary supplements in the United States, Great HealthWorks must register its facilities with the FDA under the Bioterrorism Act of 2002.6Food and Drug Administration. Registration of Food Facilities and Other Submissions Registration does not mean the FDA has approved or tested the product. It means the agency knows the facility exists and can inspect it.

The FDA does not approve dietary supplements before they reach the market. It can only act after a product is already being sold, which is what happened with the 2021 warning letter. That lighter regulatory framework is the backdrop against which Great HealthWorks operates, and it helps explain both the aggressive marketing you see on television and the periodic government intervention that follows.