F.A.Q's

Results of Clinical Testing of FORM™

This clinical trial was designed to define its clinical efficacy and safety. From December 2007 through February 2008, thirty participants were evaluated at four clinical sites located at physician-managed medical weight loss clinics. Each enrollee signed an informed consent and was provided with ninety 750mg capsules our product. Participants were instructed to take as directed and return weekly for weigh-ins, consultation and to answer study questionnaires. Information was collected weekly for four weeks from each person regarding:

• Certain personal information
• Diet and eating habits and behaviors
• Utilization
• Effectiveness
• Hunger status
• Meal portion sizes
• Any associated side effects or adverse events

The findings are summarized below:*

Participant Statistics:
Average Age: 49
Average Beginning: BMI - 30.5; Weight - 183 lbs; Height - 65 in
Average Ending: BMI - 29.3; Weight - 175 lbs; Height - 65 in
Responders: 94.1%
Average 4-week Weight Loss: 7.6 lbs (4.2% of Body Mass)
Average Number of Capsules Taken per Day: 2.1
Average Reduction in Meal Portion Size: 34.3%
Average Rating of Hunger Control Effectiveness: 86.7%
Average Time to "feel" Fullness Effect: 33 minutes
Average Duration of "Fullness" Effect: 2.5 hours
Total Doses Administered: 2,000
Total Incidence of Side-effects: 3.6%; Adverse Events: None
Additional information was also analyzed as below:*

In this study, participants were asked to rate their responses from our product's effects at each of breakfast, lunch and dinner. Our product generated a sensation of fullness or early satiety 94.1% of the time. In 5.9% of meals, patients described that "No Effect" was noted.

One of the most important findings of this or any clinical study is the determination of side effects and the recording of any study-related adverse events. Total incidence of occurrence of all study related side effects equaled 3.6%

Of importance, no adverse events were reported during the study. Slight burping for a few minutes as the capsules dissolved (within 10 minutes of ingestion) was the most common side effect reported. Occasionally, these burps were accompanied with a mild taste that lasted a few minutes.

The ability to assist participants in losing weight was also measured. Participants lost an average of 1.9 pounds per week, with an average weight loss of 7.6 pounds over the 4-week study.

Most weight management experts agree that if weight is lost too rapidly it will generally not be sustainable. Therefore, most recommend that people lose weight more slowly - generally in the range of 1 to 2 pounds per week so that the weight that comes off can stay off. Our product is designed to help people lose weight sensibly and progressively without feeling hungry or deprived in the process.

Summary:
We are very encouraged by these results. None of the investigators or any patients has any relationship with or financial interests in the Company or the technology. Both the independent investigators and the study participants volunteered to undertake the study without payments or promises of any kind.

The findings of this study, while promising, are by no means conclusive. Larger controlled trials are indicated. We are encouraged and intend to pursue larger studies in the future to learn more about the role as a novel hunger management tool.*

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FAQs

Question: What is FORM™? (Carbomer Homopolymer)
Carbomer is an industry trade name which identifies a series of crosslinked hydrogel polymers of acrylic acid. Carbomers have been in wide commercial use for decades since they are non-toxic, not absorbed, and are listed as "generally recognized as safe (GRAS)." A wide variety of carbomers are FDA-approved in products used as: bulking agents, laxatives, thickening agents, drug delivery excipients, pharmaceutical adjuvants, cosmetic emollients, and food additives, among others.*

Question: How does FORM™ work?
It's all about meal portion control...

FORM™ is NOT a "miracle weight loss pill." Each FORM™ capsule contains hundreds of microbeads made from our proprietary, non-toxic, superabsorbent polymer called SWELL™ that has been designed to expand 500 to 1,000 times its weight in water when taken as directed.*

Each FORM™ rapid-acting capsule dissolves within minutes of ingestion. The microbeads absorb the free water and expand to partially fill the stomach; promoting the release of hormones that signal the hunger center in the brain to suppress your appetite.* So by the time you sit down and start eating, you are already beginning to "feel full."*

Simply stated: FORM™ lets you eat less without feeling hungry.* And in combination with a healthy lifestyle and weight management program, most people using FORM™ tend to lose more weight than with dieting and/or exercise alone.*

Question: How do I use FORM™?
FORM™ is typically taken as 1 or 2 capsules with 6 to 12 oz. of water, 30 to 60 minutes before eating. Whether you need 1 or 2 capsules varies by individual, so see what works best for you. As a general guideline, you should start with 1 capsule, especially if you weigh 150 lbs. or less.* If you don't have a sense of fullness during the meal from one capsule, then next time try 2 capsules.* Everyone is different, so FORM™ works slightly differently for everyone.*

Question: Can FORM™ clog up my system?
NO: SWELL™ microbeads have an extremely slick and slippery surface so they do not stick to one another and they do not adhere to the mucous membranes or the linings of the GI tract.* Fully expanded, each microbead is about the size of a grain of steamed rice allowing it to easily and gently slide through the GI tract without clumping or sticking to anything.*

Question: Is FORM™ associated with GI or bowel problems?
NO: FORM™ is totally bio-inert.* It is made from a water-swelling polymer that is not absorbed or digested, neither does it absorb nutrients or other ingested materials.* FORM™ is designed to behave like many natural foods that pass through the GI tract undigested (i.e., corn, lentils, peanuts, etc.).*

Question: Does FORM™ have any significant side effects?
NO: FORM™ is a mechanical gastric bulking agent that has no nutritional value.* It does not contain ephedrine, or any stimulants. FORM™ promotes bowel regularity, but it is not a laxative; nor does it interfere with digestion, metabolism, or blood sugar levels.*

FORM™ is not known to promote any significant side effects.* It is non-fermenting and does not cause flatulence (gas).*

Question: Do I have to drink water with FORM™ capsules?
YES: Drinking 6-12 oz of tap water with each FORM™ capsule is VERY IMPORTANT for 2 reasons:

First, FORM™ capsules work best if they are swallowed whole - without chewing or breaking them open in the mouth.

Second, once the capsules dissolve in the stomach, the microbeads expand by absorbing water.* In order for the beads to expand properly, the stomach needs to have enough free water present. Six to 12 ounces of water must be taken with each capsule 30 to 60 minutes before meals for FORM™ to work safely and achieve maximal swelling effectiveness.*

(Maximum Limit- 2 capsules per meal or 6 capsules per day).*

Question: What is the maximum number of capsules that I can take with each meal?
TWO: Taken as directed, SWELL™ microbeads are designed to expand 500 to 1,000 times their weight in water (about the size of an apple).

Taking more than 2 capsules at a time (unless directed by a physician) for a single meal is NOT RECOMMENDED since this may over-distend the stomach causing severe cramping, nausea, vomiting or other complications.*

Question: How soon does FORM™ begin to work?
LESS THAN 15 MINUTES: Taken as directed, FORM's™ specialized fast-dissolving capsules release the SWELL™ microbeads quickly, which gently expand fully within about 15 minutes of ingestion.*

Once the stomach begins to expand with meals, the brain's hunger center is signaled to slow down the hunger drive; providing the user with a more rapid sense of "Fullness."*

Question: Is FORM™ recommended as a stand-alone diet or weight management tool?
NO: FORM™ works best if used as part of a healthy lifestyle in combination with regular exercise, a low-fat nutritious whole-food diet, smoking cessation, and other positive decisions that are part of a comprehensive health and weight management program.*

The makers of FORM™ also recommend supplementing the diet with a multi-vitamin formula to ensure complete absorption of all of the necessary vitamins and minerals needed for good health - some of which may become restricted in some diets and weight management programs.

Remember, before beginning FORM™ or any weight management program you should always consult with your doctor first.

Question: Can FORM™ be used with other diet products?
YES: FORM's™ natural mechanism of action compliments other weight loss products, as well as those weight management programs that may be recommended by your doctor. FORM™ can be used in combination with these technologies to obtain maximal and synergistic results.*

Question: Once I Reach my Target Weight, Can I use FORM™ as part of my daily lifestyle?
YES: FORM™ has no nutritional value.* Each capsule is drug free, stimulant free, and is non-habit-forming.* Once most people reach their target weight, the brain will attempt to adjust to the new body mass and reset its "hunger-stat" (the amount of food it needs to consume).* For some people, this process can take a year or more. In the meantime, if you still feel hungry before meals after reaching your target weight, for best results and as part of a healthy daily weight maintenance program, FORM™ consumption can be adjusted to a one or two doses daily before the main meal of the day, whatever works best for you and your body.*

Question: What happens in an overdose?
In the event of an overdose: If enough water is consumed such that the microbeads expand to cause over-distension of the stomach, gastric cramping, nausea and vomiting will ensue, which will mechanically clear the body of the excess material.*

If FORM™ is ingested in an overdose amount without sufficient water to cause vomiting, the microbeads will pass on their own with severe abdominal cramping as the primary outcome.* Intestinal obstruction is theoretically possible, but has never been reported.*

Question: Does FORM™ Damage the Environment?
NO: Carbomers are listed on the EPA's Inert Ingredients List (4B) and the Exempt from Residues List (CFR 180.960). FORM™ is incinerated with the residual biomass in waste treatment facilities. It is non-toxic and does not accumulate in groundwater, lakes, or other ecosystem niches.*

Question: Can I use FORM™ with my overweight pets?
NO: FORM™ is not intended for veterinary use.

These statements have not been evaluated by the FDA. This product is not intended to diagnose, treat, cure or prevent any disease.