Enzymatic Therapy Heartburn Free “Provides Lasting Relief,” Labeling Says

Enzymatic Therapy is positioning its Heartburn Free dietary supplement, which will be available nationwide by mid-January, as a "preventative regimen" to combat occasional heartburn and acid indigestion.

Promotional materials state the product "has been clinically shown to drastically reduce the occurrence of occasional heartburn and acid indigestion for an extended period of time."

Each Heartburn Free softgel contains 1,000 mg of the proprietary ingredient ROH10 , which labeling describes as orange peel extract (citrus sinesis) "standardized to contain a minimum of 98.5% d-limonene." Enzymatic Therapy said it licenses the patent-pending ingredient, but would not disclose the source.

Directions advise adults 18 and older to, "upon first experiencing symptoms, take one softgel capsule every other day for 20 days, and one softgel capsule as needed for occasional relief thereafter."

"While Heartburn Free may have immediate positive effects on occasional heartburn starting with the first dose, the full 20-day preventative regimen results in optimal, long-lasting relief - relief that can last six months or longer," promotional materials state.

Enzymatic Therapy noted research is underway to more clearly define the long-term effects of supplementation with d-limonene. Galveston, Tex.-based Wilkins Research Services is conducting the trial.

Wilkins also is in the process of analyzing results from a placebo-controlled, double-blind study of 20 people that concluded in December 2000. The trial found nearly 90% of participants experienced heartburn relief after two weeks of d-limonene supplementation, Enzymatic Therapy said.

Heartburn Free began shipping in early December. The supplement will be available in the digestive aid section of health food stores and will be sold to pharmacies by the firm's PhytoPharmica division. A bottle of 10 capsules carries a suggested retail price of $29.95.

Labeling claims for the product include: "Dietary supplement to relieve occasional heartburn, acid indigestion and upset stomach"; "Clinically tested"; "Provides lasting relief"; and "Does not disrupt stomach acids, allowing proper digestion."

Enzymatic Therapy originally had intended to include the claim: "Decreasing the potential for the highly acidic stomach fluid to splash up into the esophagus" in labeling, but decided to drop the language after receiving a Nov. 19 "courtesy" letter from FDA.

In the letter, the agency notes "the statement that you are making for these products, including the use of the term 'heartburn' as the name of the product, suggests... they are intended to treat, prevent or mitigate disease, namely esophageal reflux disease and heartburn." The letter responded to a structure/function claim notification from the company.

Although Enzymatic Therapy agreed to remove the questionable claim from labeling before launching the supplement, the firm chose not to remove the word "heartburn" from the product name.

Separately, Rexall Sundown said it is reviewing a Nov. 14 FDA "courtesy" letter challenging several claims made for the firm's Calcium Citrate Malate supplement.

FDA takes issue with the claim: "It helps build and maintain strong, healthy bones. Up to 40% more effective for maintaining bone density. It also offers up to 40% greater bone density in postmenopausal women over the age of 55 compared to the calcium carbonate form used in most other calcium supplements."

The agency maintains it has authorized a health claim for calcium and osteoporosis and "failure to make a claim in accordance with the requirements...subjects the product to regulation as a drug...because the product is intended to treat, cure, prevent or mitigate a disease, osteoporosis."

Rexall said it will respond to FDA in writing before the end of the year. The firm launched Calcium Citrate Malate and three other calcium supplements in September (¹ (Also see "Rexall Sundown Complete Multivitamins Feature Bilberry, Soy, Cranberry" - Pink Sheet, 29 Oct, 2001.), p. 11).

Pharmavite received a second "courtesy" letter from FDA on Nov. 14 for its Nature Made Cholest-Off supplement. The agency originally questioned several of the product's claims referring to the relationship between plant sterols/stanols and the risk of coronary artery disease (² (Also see "Pharmavite Cholest-Off Claims Cited In FDA “Courtesy” Letter" - Pink Sheet, 26 Nov, 2001.), p. 19).

In its most recent letter, FDA says the claims "Heart healthy" and "Cholesterol fighter" represent the product "as being intended to reduce blood cholesterol levels and support cardiovascular health."