WHAT IS FUNCTIONAL DYSPEPSIA (FD)?
FD (persistent or recurring indigestion with no known organic cause) is a relatively common and often frustrating condition. It is a disorder of sensation and movement in the organs of the upper digestive tract where the normal downward pumping and squeezing is altered, and the digestion and absorption of food nutrients is affected. FD often reoccurs over time.

WHAT ARE THE SYMPTOMS OF FD?

In addition to impacting the digestion and absorption of food nutrients, the main symptoms of FD are in the upper belly and include:

• Pain or discomfort
• Early fullness with meal
• Nausea
• Bloating
• Belching

WHAT CAUSES FD?

Most doctors are not sure what causes FD. In the absence of a known organic cause, it is thought that the function of the stomach and the first part of the small intestine (the duodenum) may be altered in some way, which can disturb the movement, digestion and absorption of food.

HOW COMMON IS FD?

If you suffer from FD, you are not alone. It is estimated that one in six adults in the United States have FD. FD can begin at any age.

WHAT ARE THE DISTINCT NUTRITIONAL REQUIREMENTS FOR PEOPLE WHO HAVE FD?

People with FD often do not eat regularly or normally which may affect their normal intake of nutrients. Also, the digestion of food and absorption of nutrients is affected due to disturbances in the GI tract.

WHAT IS FDgard®?

FDgard® is a medical food specially formulated for the dietary management of FD. The combination of caraway oil and peppermint oil (primary ingredient: l-Menthol) has been shown in several clinical studies* to be effective in helping manage FD. FDgard® capsules deliver individually triple-coated, targeted-release, solid-state microspheres of caraway oil and l-Menthol quickly and reliably to the upper belly.In addition to caraway oil and l-Menthol, FDgard® also provides fiber and protein.

WHAT SYMPTOMS OF FD DOES THE COMBINATION OF CARAWAY OIL AND PEPPERMINT OIL MANAGE?

The combination of caraway oil and peppermint oil (primary ingredient: l-Menthol) has been shown in several randomized, placebo-controlled studies* to be effective in the management of FD. Clinical studies have shown that the combination can help manage the syndrome of FD symptoms, which include the frequency and intensity of upper belly pain, discomfort, intensity of sensations of pressure, abdominal heaviness and fullness.**

IS FDgard® A DRUG OR A DIETARY SUPPLEMENT?

FDgard® is in a unique category called medical foods, which is separate from the drug or dietary supplement categories. Medical foods do not require FDA pre-approval but must comply with FDA regulations. While FDgard® does not require a prescription, it should be used under medical supervision. Medical foods may be accessible in retail stores as nonprescription products.

HOW DOES FDgard® WORK?

Caraway oil and peppermint oil (primary ingredient: l-Menthol) have a history of working in FD. Until now, targeted delivery to the upper belly has posed a challenge. FDgard®, utilizes breakthrough science to calm the angry upper belly™ through the precision of SST® (Site Specific Targeting) technology. This technology delivers individually triple-coated, targeted-release, solid-state microspheres of caraway oil and l-Menthol quickly and reliably where they are needed most in FD – the upper belly.

IS FDgard® APPROVED BY THE FDA AND IS IT SAFE?

Like all medical food products, FDgard® does not require prior approval from the FDA. However, even food products can be unsafe if used improperly. Caraway seeds and peppermint, the precursors of caraway oil and l-Menthol, have been consumed by mankind for centuries as part of the diet. FDgard® is a medical food and as required, contains only ingredients that are GRAS (Generally Recognized as Safe) or approved food additives. FDgard® is manufactured under GMP (Good Manufacturing Practices) with no added fat, sugar, salt, starch, yeast, wheat, gluten, corn, lactose, egg, soy, peanuts, shellfish or preservatives.

As with many foods and food extracts, in rare cases caraway oil or l-Menthol can cause allergic reactions.

Talk to your physician to see if FDgard® is right for you. If you suffer from gallstones, consult your physician before taking FDgard®. Be sure to let your physician know if you are pregnant or nursing.

WHAT IS A MEDICAL FOOD AND HOW DOES IT DIFFER FROM A DIETARY SUPPLEMENT OR A DRUG?

A medical food is a product regulated by law. It is often placed on the spectrum between a food and a drug. A medical food is used in the dietary management of a disease. It is required to be used under medical supervision. It is allowed to be sold as a nonprescription product.

A dietary supplement is an entity regulated by law. The products are intended to maintain health and wellness in a healthy population. Supplements are usually sold as a nonprescription product.

A drug and its purpose are approved by the FDA based on safety and efficacy. A drug is usually sold as a prescription product.

For more information on medical foods visit:
http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/MedicalFoods/ucm054048.htm

HOW DO I TAKE FDgard®?

FDgard® should be taken as directed by your physician. (Usual adult dosage: 2 capsules, 2 times a day or as needed. Do not exceed 6 capsules per day. Take at least 30 minutes before or 30 minutes after food, with water. Swallow capsules whole or mix contents with applesauce. Do not chew.)

HOW LONG SHOULD I TAKE FDgard®?

Consult with your physician on how long you can take FDgard® for the dietary management of FD. (Usual duration: Most of the FD challenges should be reduced or resolved within the first month of taking FDgard®. If they worsen at any time, consult with your physician. As with most medical foods, no chronic use data is available.)

SHOULD I KEEP TAKING MY ACID REDUCERS ALONG WITH FDgard®?

Ask your doctor if you should continue to take your acid reducer while also taking FDgard®. If you continue to take an acid reducer such as an antacid for heartburn or GERD, avoid taking it and FDgard® together. Take FDgard® first and then take your acid reducer one hour later. Antacids or H2 blockers (such as Zantac® or Pepcid®), can lower the level of acid in the stomach, which may cause a premature release of FDgard®.

FDgard® is designed to move through the stomach and release caraway oil and l-Menthol predominantly in the upper part of the small intestine - the duodenum — just beyond the stomach. Too much early release in the stomach may cause heartburn.

CAN FDgard® BE TAKEN BY CHILDREN WITH FD?

Consult with the physician for use in children.

IS THERE ANY GLUTEN OR LACTOSE IN FDgard®?

FDgard® has been developed to be free of gluten and lactose.

CAN THE CONTENTS IN THE FDgard® CAPSULE BE CRUSHED OR CHEWED?

The FDgard® capsule should never be crushed or chewed. If one has difficulty swallowing, one can open the capsule and mix the contents with applesauce.

WHAT MIGHT I FEEL AFTER TAKING FDgard®?

As FDgard® goes to work, you may sometimes experience a mild tingling sensation in your upper belly, often within 30 minutes. This sensation should subsequently subside. FDgard® is designed to release trapped gas in your gut. You may sense an aroma when the trapped gas is burped out. This is not an unusual experience and indicates the product is working to help calm the angry upper belly™.

WHAT DOES “USE UNDER MEDICAL SUPERVISION” MEAN?

Like all medical foods regulated under the Orphan Drug Act Amendments of 1988 in section 5 (360ee (b) (3)), FDgard® should be given to patients receiving active medical supervision for their FD. Physicians should provide a management plan for a patient’s FD and instructions for use of FDgard®.

WHERE CAN FDgard® BE FOUND?

FDgard® is available in the digestive aisle at CVS, Walgreens, and Rite Aid, and online at CVS.com.

WHAT ARE THE INGREDIENTS IN FDgard®?

Each FDgard® capsule contains 25 mg of caraway oil and 20.75 mg of l-Menthol. Other ingredients include microcrystalline cellulose, gelatin, methacrylic acid copolymer, methycellulose, hypromellose, triethyl citrate, croscaramellose sodium, glycerol monostearate, FD&C Red #3 and FD&C Blue #1.

FDgard® is manufactured under GMP (Good Manufacturing Practices) with no added fat, sugar, salt, starch, yeast, wheat, gluten, corn, lactose, egg, soy, peanuts, shellfish or preservatives.

IS FDgard® COVERED BY HEALTH INSURANCE?

FDgard® is not generally covered by health insurance. In the marketplace, patients welcome the effectiveness, the good tolerability profile, the relatively low cost, the freedom from insurance company bureaucracy and easy retail access.

IS FDgard® REIMBURSABLE UNDER FLEXIBLE SAVINGS ACCOUNTS (FSAs)?

Patients should consult their medical plan to find out whether medical foods such as FDgard® are reimbursable through their FSAs. Some plans have been known to provide reimbursement for medical foods based on physician requests.

ARE THERE ANY FOOD DYES IN FDgard®?

The food dyes are only in the capsule shell. You can open the capsule and mix the contents (which do not contain food dyes) with applesauce.

WHAT IS IM HealthScience®?

IM HealthScience®, a privately held company based in Boca Raton, Florida, that pioneered IBgard®, was founded in 2010 by a team of highly experienced pharmaceutical research, development and management executives. The company is dedicated to developing medical foods for the dietary management of gastrointestinal issues where there is a high unmet need, including Irritable Bowel Syndrome (IBS), Functional Dyspepsia (FD), Ulcerative Colitis (UC) and Crohn’s Disease (CD). The IM HealthScience® advantage comes from developing products based on its patented, targeted-delivery technology called SST® (Site Specific Targeting) technology.

*Coon JT, Ernst E. Systematic review: herbal medicinal products for non-ulcer dyspepsia. Aliment Pharmacol Ther. 2002;16:1689-1699.

**May, B. et al. Efficacy and tolerability of a fixed combination of peppermint oil and caraway oil in patients suffering from functional dyspepsia. Aliment Pharmacol Ther. 2000; 44:1671-1677.