HCP Frequently Asked Questions
FD is a remitting-relapsing functional bowel disorder. It is characterized by recurring indigestion with no known organic cause. It is a relatively common, under-diagnosed,1 under-managed 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 where the digestion and absorption of food nutrients is affected.
In addition to impacting the digestion and absorption of food nutrients, the main symptoms of FD include, at varying times, some or all of the following*:
- Abdominal pain, discomfort, or cramping
- Difficulty finishing a meal
In the absence of a known organic cause, it is thought that FD is associated with the disruption in the lining of the gut (gut mucosal barrier) and reversible, localized, low-grade immune activation.2,3,4 Gut mucosal barrier disruption can cause motility dysfunction (spasms) and irritated nerve endings (abdominal pain and cramps). All of this also involves the impaired ability to digest and absorb food nutrients.5
Caraway oil and l-Menthol have anti-inflammatory,6 pro-motility,7 gastro-protective,8,9 and synergistic visceral analgesic properties.10 Caraway oil and l-Menthol can help to enhance nutrient absorption through the intestinal walls,11 making it well suited for the management of FD. Caraway oil and l-Menthol has also been shown to help normalize intestinal transit times7 - thus helping normalize nutrient absorption. Common triggers are food,12 stress,13 and environment.14
If FD is suspected, consult with a physician about confirming FD and then developing a program to manage it.
The combination of caraway oil and peppermint oil (primary component: 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 can include, at varying times, some or all of the following*:
- Abdominal pain, discomfort, or cramping
- Difficulty finishing a meal
If you suffer from FD, you are not alone. It is estimated that one in six adults in the United States have FD.4 FD can begin at any age.
FDgard is a medical food specially formulated for the dietary management of FD. The combination of caraway oil and peppermint oil (primary component: l-Menthol) has been shown in several clinical studies15 to be effective in helping manage FD. FDgard capsules are designed to 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 amino acids (from gelatin protein).
FDgard should be taken as directed by a physician. (Usual adult dosage: two capsules, two times a day. Take 30-60 minutes before meal(s) with water.* Do not exceed six capsules per day. Swallow capsules whole or open capsules and mix contents with applesauce. Do not chew.) FDgard sachets (institutional packs) should be administered by a healthcare provider through a nasogastric or gastrostomy tube.
Patients should consult with a physician before taking FDgard with or without other products. FDgard may interact with certain medications such as cyclosporine, affecting how the body can break them down.
Caraway oil and peppermint oil (primary component: 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 through the precision of SST® (Site Specific Targeting). 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.
Caraway oil and l-Menthol have anti-inflammatory,6 pro-motility,7 gastro-protective properties,8,9 and synergistic visceral analgesic properties.10 Caraway oil and l-Menthol can help to enhance nutrient absorption through the intestinal walls,11 making it well suited for the management of FD. Caraway oil and l-Menthol have also been shown to help normalize gastric accommodation, transit times,7 and the lining of the GI tract- thus helping normalize nutrient absorption.
As FDgard goes to work, one may sometimes experience a mild tingling sensation in the gut, often within 30 minutes. This sensation should subsequently subside. FDgard is designed to release the trapped gas in the gut and therefore, one may sense a pleasant aroma when the trapped gas gets burped out. This is not an unusual experience and indicates the product is working.
FDgard should be taken as directed by a physician. Peppermint and caraway have been part of the diet for centuries. Many physicians recommend FDgard be taken on a daily basis, preferably before a meal. Like many other medical food products, there is no chronic use data available.
FDgard is available in the digestive aisle at CVS, Walgreens, and Rite Aid, and online at Amazon.com.
The FDgard product line includes capsules and an institutional pack (sachets). In some cases, when there is difficulty swallowing whole capsules, FDgard capsules can be opened and the microspheres sprinkled on applesauce. The institutional pack is designed for nasogastric tube or gastronomy tube administration in an institutional setting.
Never crush or chew the FDgard capsule. Swallow capsules whole or mix the microspheres with applesauce.
Consult with the physician for use in children.
Each capsule contains: 25 mg caraway oil and 20.75 mg l-Menthol
Other ingredients include microcrystalline cellulose, gelatin, methacrylic acid copolymer, methycellulose, hypromellose, triethyl citrate, croscarmellose sodium, glycerol monostearate, FD&C Red #3 and FD&C Blue #1.
FDgard is manufactured in the USA under Good Manufacturing Practices with no added fat, sugar, salt, starch, yeast, wheat, gluten, corn, lactose, egg, soy, peanuts, shellfish, tree nuts, milk, fish, or preservatives.
The fiber and amino acids (from gelatin protein) in FDgard are designed to further help normalize the lining of the gut. In addition to caraway oil and l-Menthol, each FDgard serving of 2 capsules provides approximately 360 mg of fiber and approximately 290 mg of amino acids (from gelatin protein). These, too, are intended to help toward normalizing the lining of the gut (gut mucosal barrier) and reversible, localized, low-grade immune activation.7,16 The l-Menthol in peppermint oil has anti-inflammatory,6 pro-motility,7 and synergistic, visceral analgesic properties.10
FDgard utilizes breakthrough science via SST (Site Specific Targeting). This technology delivers microspheres of caraway oil and l-Menthol, along with fiber and amino acids (from gelatin protein), quickly and reliably where they are needed the most in FD—in the upper belly.
Never before have caraway oil and l-Menthol been formulated into individually enteric-coated microspheres delivered to the upper belly. Each microsphere in an FDgard capsule has three layers of coating, specifically designed for the travel and release of actives in the desired sections of the GI tract.
- The outermost layer is non-mucoadhesive. This allows the microspheres to travel easily through the esophagus and prevents their mucoadhesion to the stomach wall and large food particles.
- The middle layer contains a pH-triggered coating that should not dissolve until it passes the pylorus.
- The innermost layer preserves the caraway oil and l-Menthol matrix in the core until the pH change triggers the desired release in the upper belly.
- The core of the microspheres contains a fiber matrix that entraps caraway oil and l-Menthol in a solid state and enables the release of caraway oil and l-Menthol, along with fiber and amino acids (from gelatin protein) in the upper belly.
FDgard has been developed to be free of gluten and lactose.
Doctors use guidelines and their own experience in deciding how to proceed. In the vast majority of patients, an organic cause is neither suspected nor seen by physicians. The list of possible organic causes the doctor may test for include:17
- Peptic ulcers
FDgard is a medical food specially formulated for the dietary management of Functional Dyspepsia, which occurs primarily in the upper belly, above the navel. IBgard is a medical food specially formulated for the dietary management of Irritable Bowel Syndrome (IBS), which occurs primarily in the lower belly, below the navel.
People with FD often do not eat regularly or normally, which may affect their normal intake of nutrients. Also, their digestion of food and absorption of nutrients may be affected due to motility disturbances in the GI tract. Patients with FD have been known to experience weight loss because of reduced food intake or retention of food.18
The inflammatory cascades19 (e.g. eosinophils in the duodena)2 related to FD are associated with permeability dysfunction, which, in turn, affects the digestion and absorption of nutrients.
Deficiency of folate and B12 has been shown in FD. There is an association of other micronutrient deficiencies and FD.20
There is increasing evidence that impaired mucosal defense mechanisms are implicated in the pathogenesis of functional gastrointestinal disorders (FGIDs), allowing inappropriate immune activation.21,22
More recently, perturbations of GI microbiota, altered mucosal permeability and abnormal mucosal defense mechanisms have been implicated in the pathogenesis of some FGIDs.23-28
Over 90% of nutrient digestion and absorption takes place in the small intestine.29 With FD, this digestive and absorptive process is disrupted in several ways. The bile acid flow is disrupted as part of the FD cascade of disruption.30 Peppermint oil (primary component: l-Menthol) helps restore secretory function such as bile flow.31 The German Commission E monograph for peppermint oil (primary component: l-Menthol) lists its use as an anti-spasmodic for bile ducts.32 This and other known activities of peppermint oil (primary ingredient: l-Menthol) are helpful in digestion and absorption.
Dietary modification alone, as a management strategy, has had mixed success. Fiber is helpful. Exclusionary diets help in the short term but lead to nutritional imbalances and adherence issues in the long-term. Diet alone does not address the complex disruptions of the upper belly.15
To effectively manage FD, it is important to help normalize the gut mucosal barrier dysfunction and its associated reversible, localized, low-grade inflammation.2
Now, doctors increasingly use medical foods, such as FDgard, to help normalize the digestion and absorption of food nutrients and to help manage FD symptoms.
FDgard is specially formulated to meet the distinctive nutritional requirements of FD that cannot be met with dietary modification, alone. FDgard is designed to supply microspheres of caraway oil and l-Menthol, along with fiber and amino acids (from gelatin protein), to the upper belly. The anti-inflammatory,6 pro-motility,7 and visceral analgesic properties10 of caraway oil and l-Menthol, help toward normalizing the digestion and absorption of food nutrients, and to manage the symptoms of FD.
By improving gut health in the first place, FDgard helps prevent nutritional problems later.
FDgard is a medical food product and not a drug or a dietary supplement. Medical foods are often described as a medical products category between foods and drugs. Like all medical foods, FDgard does not require prior approval from the FDA but is subject to regulations. While FDgard does not require a prescription, it should be used under medical supervision.
Like all medical foods, FDgard does not require prior approval from the FDA but is subject to regulations. Peppermint and caraway have been consumed by mankind for centuries as part of the diet. As a medical food, FDgard must contain ingredients that are Generally Recognized as Safe (GRAS) or are approved food additives. A post-marketing safety analysis of consumers who took FDgard over a 1 year period** found that there were no reported serious adverse events associated with the use of FDgard. The reported non-serious adverse events showed no trend in tolerability and may represent normal event patterns associated with an FD population.**
As with many food extracts, in rare cases, peppermint oil (primary component: l-Menthol) and caraway oil can cause allergic reactions. Please consult with a physician for an FD management program that may include FDgard. If pregnant or breastfeeding, be sure to consult with a physician.
A medical food belongs to a product category 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 or a condition. It is required to be used under medical supervision. It is allowed to be sold as a nonprescription product.
A dietary supplement also belongs to a product category regulated by law. Dietary supplements can make what are called structure/function claims. The products are intended to maintain health and wellness in a healthy population. Dietary supplements cannot make disease or treatment claims. Supplements, like medical foods, are available as nonprescription products.
A drug and its claim structure are approved by the FDA based on safety and efficacy. A drug is usually sold as a prescription product.33
Like all medical foods regulated under section 5 (b) of the Orphan Drug Act (21 U.S.C. 360ee (b) (3)), FDgard must be given only to patients receiving active medical supervision for their FD. A physician should provide an FD management program and instructions for use of FDgard.
Like many nonprescription products, FDgard is not generally covered by health insurance. In the marketplace, patients welcome the efficacy, the relatively low out-of-pocket cost, the freedom from insurance company bureaucracy, the good tolerability profile and the endorsement of many physicians. Marketplace satisfaction with FDgard is well over 80%.§
Patients should consult their medical plan to find out whether medical foods, such as FDgard are reimbursable through FSAs. Some plans have been known to provide reimbursement for medical foods based on physician requests.
No. FDgard is available without a prescription and accessible in the digestive aisle at most retail drug chains. However, FDgard should be used under medical supervision.
FDgard has not been studied in a pediatric population.
To ask to see a representative, please click on the Contact Us tab above and fill out the information. A representative should be in touch with your office shortly.
Please visit the FDgard Samples site and fill out the sample request form to ask to obtain complimentary FDgard samples or call 1-855-GUT-GARD (1-855-488-4273).
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, can lower the level of acid in the stomach, which may cause a premature release of actives in 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 (upper belly), just beyond the stomach.
*Please note that this recommendation has been updated based on input from the company's medical advisors.
The capsule shell contains approved food dyes. Therefore, if a patient is concerned about consuming food dyes, he/she should be instructed to open the capsule and mix the microspheres (which do not contain food dyes) with applesauce. The microspheres should not be chewed.
IM HealthScience® (IMH) is the innovator of IBgard® and FDgard® for the dietary management of Irritable Bowel Syndrome (IBS) and Functional Dyspepsia (FD), respectively. In 2017, IMH added Fiber Choice, a line of prebiotic fibers, to its product line via an acquisition. IMH is a privately held company based in Boca Raton, Florida. It was founded in 2010 by a team of highly experienced pharmaceutical research and development and management executives. The company is dedicated to developing products to address gastrointestinal issues where there is a high unmet need. The IM HealthScience® advantage comes from developing products based on its patented, targeted-delivery technologies called Site Specific Targeting (SST®). For more information, visit www.imhealthscience.com to learn about the company, or www.IBgard.com or www.FDgard.com.