The QMN Weekly Bulletin
Pharmaceuticals / Inspections and Audits

Texas Drugmaker Warned for Misbranded Products

Feb. 2, 2018

The FDA warned Young Health Products for marketing drug products on its website that are not safe and effective for their promoted uses.

Several of the Addison, Texas firm’s supplement products, such as Balance Drops, Omega 3-6-9 Fish Oil and Liquid Vitamin D3, were being marketed as drugs because their intended uses were to treat, cure or prevent disease, the agency said.

Because the drugs were not approved by the FDA for their advertised uses, they are considered “new drugs” and may not be introduced into interstate commerce without prior agency approval.

For example, the firm advertised on its website that its Omega 3-6-9 Fish Oil product contains ingredients that help treat neurological illnesses and cardiovascular disease, while claiming its Liquid Vitamin D3 product “helps regulate blood pressure” and “relieves body aches & pains by reducing muscle spasms.”

In addition, it claimed its Balance Drops product helps prevent osteoporosis, as it “help[s] the body maintain the acid/base balance in blood and other tissues.”

The products were also found to be misbranded, as they did not include adequate directions for their intended uses. Because they were intended to treat one or more diseases that are not self-diagnosable or treatable without a physician, the firm could not possibly write adequate directions for the average person.

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