Fit America  touts itself as the very best and most practical 100% Natural system of weight loss that helps an individual lose weight without dieting.  Fit America is a natural weight control that is composed of 13 herbs and minerals that supposedly "help suppress appetite, regulate the bowels and kidneys, and stimulates the metabolism so the body uses the foods consumed more efficiently."  The Fit America program requires a high protein, low carbohydrate diet.  Fit America promises that an individual can expect to lose up to 10 to 18 pounds per month with a proper balance of food and water consumption.  These herbal supplements include astragalus, bitter orange, cascara sagrada, fo-ti, gingko, english hawthorn, henna, licorice root, ma huang, and valerian root.  It is recommended that individuals who utilize the Fit America program begin by taking one gray colored herbal capsule twice a day and one peach colored herbal capsule once a day.  The Fit America program then encourages the individual to gradually increase their dosage of grey colored capsules but to take no more than eight in one day¹.  For a 7 - 10 day starter kit of Fit America, the price is $29.95.  For a 45 day supply, the cost is $139.00.  I will attempt to review the safety of these herbs and their effects on the human body.  

Herbal Regulations 

    When a pharmaceutical company desires to market a prescription drug, they must meet certain procedures and standards established by the Food and  Drug Administration (FDA).  These procedures can last many years and incur hundreds of millions of dollars of cost for the pharmaceutical company.  Before a drug can be marketed, it must first be patented and then pass three phases of clinical investigation.  In Phase I, the drug is tested by giving a small amount of it to a limited number of people.  At this stage, the researchers are looking for the pharmacological effects on the body such as side effects.  In Phase II, individuals who have the condition that the drug is supposed to treat are tested.  Approximately 100 people are tested in this phase.  If Phase II shows signs of promise, then clinical investigations move into Phase III.  Phase III is the most extensive phase, whereby the drug (as in Phase II), is administered to those who have the condition the drug is supposed to treat, but this time it is administered to thousands of people from different parts of the country, different races, genders, and ages.  If Phase III is successful and the drug is found to be effective, the FDA weighs the potential dangers and benefits before allowing it to go on sale to the public.  On average, before a new drug is allowed to go on sale to the general public, the pharmaceutical company will have invested approximately 8 - 10 years and 360 million dollars².
    Traditional herbal therapies, such as Fit America, cannot be patented and thus do not have to undergo the exhaustive and expensive FDA required clinical trials.  By default, many medicinal herbs are not regulated by the FDA because they are not legally considered drugs.  The most the FDA can do is suggest that manufacturers of herbal therapies provide customers with scientific data in support of advertising claims but in no way can they require them to perform tests like they do drug companies.

The Problem with Herbs

    Herbal dietary supplements such as Fit America, are touted as being all "natural".  Many people who consume these herbs and believe them to be all "natural", fail to realize that herbs are composed of chemicals that are bioactive in nature and include some that contain the possibility of being toxic.  Medicinal herbs are not required by law to demonstrate safety or efficacy before they are marketed and they are not regulated for quality like FDA approved over-the counter and prescription medications.  The herbs that are ingested contain an array of chemicals.  These chemical concentrations vary considerably depending on genetics, growing conditions, plant parts used, time of harvesting, preparation, and storage.  In addition, at any stage of the process, from harvesting to packaging, herbs may be contaminated and/or misidentified³. The makers of natural herbal products such as Fit America are allowed to make claims without evidence and are not required by law to track, investigate, or report any adverse reactions their products may have-- another safety precaution required of drug manufacturers⁴.
 

Herbal Safety Concerns
 
    The herbs that are encapsulated in Fit America, all produce bioactive chemicals which have various effects on the body.  Two of the herbs contained in Fit America are cascara sagrada and henna.  Both of these herbs are known for their laxative effects.  Cascara sagrada is marketed as one of natures better laxatives, a great remedy for constipation  http://vitawise.com/topic110 and are designed for occasional use.  Cascara is historically known as a strong stimulant laxative and diuretic.  Cascara is not supposed to be used for more than a week and prolonged usage results in dependency, cramping, diarrhea, and an imbalance in essential electrolytes- calcium, sodium, and potassium- that the body needs for energy.  Abuse of laxatives such as cascara deplete the body's potassium stores which can induce life threatening hypokalemia.  An individual frequently using laxatives may induce dependency where laxative usage is necessary in order to incur normal bowel movements.  After chronic use of laxatives, the individual may suffer from constipation and reflex peripheral edema.  Using a stimulating laxative, like cascara, longer than the recommended 1 or 2 weeks can also cause intestinal sluggishness  http://www.pyruvate1.com/products/cc/ .
    Another herb that is found in Fit America is Valerian root.  Valerian root is advertised and marketed as an herb that is used to alleviate pain and promote sleep.  It is intended for use by individuals who possess a nervous disposition  http://1001herbs.com/valerian/ .  This herb is also not without its negative side effects.  In one case study conducted by Gargas et al, they presented a man with a case of serious cardiac complications and delirium associated with withdrawal of valerian root.  The man in question had taken 530 mg - 2 gm of valerian root 5 times a day for many years.  When the patient discontinued use of valerian root, he had high output cardiac failure and a mental status examination that revealed signs of delirium.  Since Valerian root is similar to benzodiazepines, doctors placed him on benzodiazepines which resulted in an improvement of signs and symptoms.  It is believed that the benzodiazepines exerted an anxiolytic  and adverse effect.  These researchers hypothesized that valerian root produces a benzodiazepine-like withdrawal syndrome after an abrupt stop of large doses of valerian root.  Reversal of symptoms with benzodiazepines  strengthened their hypothesis and led them to conclude that physicians should be made aware that valerian root may be associated with serious withdrawal symptoms when followed by abrupt discontinuation⁵.
            While these two previous herbs seem to have negative effects, there lies a more potentially dangerous herb in Fit America capsules.  This herb is known as ma huang.  Ma huang is "used...to treat bronchial asthma, cold and flu, chills...and is considered to have a diaphoretic, diuretic, CNS stimulating and anti-asthmatic activity."  http://www.smartbasic.com/glos.herbs/ephedra.html .  Ma huang is more commonly known as ephedra and ephedrine.  From December 1993 to September 1995, the Texas Department of Health (TDH) received approximately 500 reports of adverse events in individuals who used dietary supplements that contained ephedrine.  Adverse effects of this herb range from tremor and headache to death.  There have also been reports of stroke, chest pain, seizures, vomiting, palpitations, coronary spasm, paranoid psychoses, and coma⁶. To date, the FDA has linked 17 deaths to ma huang, and more than 800 people have been treated for side effects.
    One side effect of ma huang is known as ephedrine nephrolithiasis, or renal toxicity of ephedrine.  Powell, et al⁷. conducted research on individuals with kidneys stones.  With assistance from Louis C. Herring and company, they analyzed kidney stones.  Within these stones, there were three compounds-ephedrine, norephedrine, and pseudoephedrine, which are normally not present in kidney stones.  Questionnaires were then sent to 15 individuals who had ephedrine metabolites in their kidney stones.  6 individuals admitted some use of ephedrine and seven individuals admitted abusing ephedrine.  The researchers came to the conclusion that use of ephedrine containing substances induced ephedrine nephrolithiasis- meaning ephedrine usage had led to the formation of kidney stones.  This ephedrine nephrolithiasis was supported by a case study by Blau⁸, who reported ephedrine nephrolithiasis due to chronic ephedrine abuse.
    Another side effect which has led to death in some ma huang users has been myocardial infarction.  One case study by Cockings and Brown⁹ describes a case of myocardial infarction in a 25 yr. old man.  This man injected himself intravenously with ephedrine.  The individual became afebrile, and was rushed to the hospital.  It is hypothesized by the researchers that the myocardial infarction was caused by the ephedrine which intensely diffused vasoconstriction of the coronary and systemic arterial systems.  This led to a decrease in myocardial diffusion, leading to left ventricular failure and a fallen blood pressure.
    A final study investigated why botanical ephedrine such as ma huang has an increased incidence of toxicity in comparison to synthetic ephedrine.  Gurley, et al¹⁰. attempted to link toxicity with differing rates of absorption by the body.  They took ten volunteers who were in good health, and not taking any continuous medications or using alcohol.  There were four phases where subjects were given one of four products during each phase.  Three of the products were "natural", botanical ephedrine, while one product was synthetic ephedrine.  They then performed tests to examine the pharmacological effects of each product.  The researchers found minimal differences in the rate of absorption between the four products, thus disproving the possibility that absorption rates profoundly impacted and increased the incidence of ma huang toxicity.  They then searched for why products containing ma huang have been associated with high incidences of morbidity and mortality.  They came to the conclusion that product marketing is the likely contributor to recent episodes.  It is believed that ma huang toxicity is a result of accidental overdose prompted by exaggerated off-label claims and a belief that "natural" medicinal agents are inherently safe.  People believe the more they consume, the greater the results.
    Ma huang may be touted as "natural", but that does not mean that it is safe.  Toxic effects occur in the cardiovascular and central nervous systems.  In addition to all of its side effects, ma huang can produce tachyphylaxis "(a progressive decrease in response after repetitive administration of a pharmacologically active substance) to its effects on blood vessels and bronchial smooth tissue."¹¹  Finally, these adverse effects do not always depend on the dose consumed.  Adverse effects such as acute cardiovascular effects also occur with low dosages in healthy people.
 

Final Comment

    When people purchase products such as Fit America dietary supplements, there is a sense of hope and trust in its ability to work safely.  Unfortunately, many who have used herbal dietary supplements in the hope of losing weight have found themselves fighting for their lives.  While not ignoring the many positive effects herbs can have, one must be cautious when consuming them.  Along with an expectation of a 10-18 pound loss per month, (which is still unproven) one can expect palpitations, dizziness, nervousness, electrolyte imbalance, and diarrhea (which is probably why Fit America is offering a free water bottle with purchase!).
 

Bibliography

    1- Men's Health Magazine.  February 1999.  "Rating the Fat Fighters", Czarnecki, Joanne.
    2- Ray, Oakley and Ksir, Charles.  Drugs, Society, and Human Behavior.  McGraw-Hill.  1999.
    3- Jones, TL.  "Dangerously revved. Ephedrine misuse poses health hazards."  Texas Medicine.  92(5):52-3, 1996 May.
    4- O'Hara M, et al.  "A Review of 12 commonly used medicinal herbs"  Archives of Family Medicine.7(6):523-36, 1998 Nov-Dec
    5- Gargas HP, et al.  "Cardiac complications and delirium associated with valerian root withdrawal"  JAMA. 280(18):1566-7, 1998 Nov 11
    6- Anonymous.  "Adverse Events Associated with Ephedrine-Containing Products--Texas, December 1993 - September 1995"  JAMA. Vol 276, No. 21, Dec 4, 1996.
    7- Powell T, et al.  "Ma-huang strikes again: ephedrine nephrolithiasis"
American Journal of Kidney Diseases. 32(1):153-9, Jul 1998.
    8- Blau JJ.  "Ephedrine nephrolithiasis associated with chronic ephedrine abuse"  Journal of Urology 160(3 Pt 1);825, 1998 Sep.
    9- Cockings, JG. and Brown, M.  "Ephedrine abuse causing myocardial infarction."  Medical Journal of Austrailia.  167(4):199-200, 1997 Aug 18.
    10- Gurley, BJ et al.  "Ephedrine pharmacokinetics after the ingestion of nutritional supplements containing Ephedra sinica (ma huang)."  Theraputic Drug Monitor.  1998 Aug;20(4):439-45
    11- Mack, RB.  "All but death, can be adjusted.  Ma huang (ephedrine) adversities."  North Carolina Medical Journal.  58(1):68-70, 1997 Jan-Feb.

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