The FDA cited device manufacturer Sybaritic of Bloomington, Minnesota following a Feb. 22 to March 7 inspection for failing to comply with the terms of a consent decree.
The firm had signed a consent decree of permanent injunction in January 2010 and the agency inspection found that it continued to market its products with unapproved health claims even though the decree specifically prohibited it from designing, manufacturing, processing, packing, repacking, holding, distributing, importing or exporting any device.
When an injunction is granted, the FDA has a continuing duty to monitor the injunction and to advise the court if the defendants fail to obey the terms of the decree. If a decree is violated, the agency must consider a civil or criminal contempt of court, or other regulatory action.
Sybaritic makes a number of products for which it makes health claims. For example, it markets medical spas such as its Cocoon Wellness Pro that the firm said increases circulation and metabolism, removes toxins and helps manage weight loss.
It also markets the SaunaLux 360 infrared sauna, which the firm claims has healing and energy benefits. On its website, Sybaritic said that the SaunaLux 360 “harnessed the power of red chromotherapy,” and made a number of claims that the red chromotherapy lighting increases vitality, strength, alertness, circulation and the body’s natural healing properties. It also claimed the lighting helps heal colds, arthritis, sluggish conditions and stimulates blood flow, as well as stimulating and producing red blood cells.
Additional claims included cosmetic healing, cardiovascular health, decreased heart rate and kidney filtration due to reduced loss of electrolytes.
The 483 said the firm failed to comply with the consent decree because it did not provide a copy of the consent decree to new associates, including suppliers.
The company also failed to comply with the consent decree because it failed to notify the agency “before any creation or dissolution of subsidiaries, franchises, affiliates, or ‘doing business as’ entities.”
Read the Sybaritic Form 483 here: www.fdanews.com/07-11-18-sybariticinc483.pdf.