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Hydroxycut, Proof or Placebo? By: Debbie McAlear &Kyle Heuer Stance The Food and Drug Administration does not provide enough regulation over dietary supplements such as Hydroxycut. Hydroxycut is a clear example of the money that can be made by tricking consumers into buying unsafe and ineffective products. The FDA must change their regulation policies to provide more protection for the naive consumer who needs aid in losing weight. Cultural Epidemic Obesity has become an increasingly important public health problem in the United States. More than 30% of adults are obese and 65% overweight Cultural Epidemic The use of dietary supplements for weight loss has become increasingly popular, $55.4 billion spent in the U.S. in 2006 for weight loss and diet control 36% of adults are using some form of complementary or alternative medicine, Cultural Epidemic Dietary Supplement Product Sales and Market Share by Distribution Channel, 1995 and 1996 Table 5.5 http://www.cfsan.fda.gov/~comm/ds-econ5.html#1 http://www.cfsan.fda.gov/~com m/ds-econt.html Dietary Supplement and Dietary Supplement and Health Education Health Education Act of Act of 1994 1994 Signed by Bill Clinton on October 25, 1994 Signed by Bill Clinton on October 25, 1994 To meet the concerns of consumers To meet the concerns of consumers and and manufacturers manufacturers Help ensure that safe and appropriately Help ensure that safe and appropriately remain available labeled labeled productsproducts remain available to thosetowho those who want to use them. want to use them. Dietary Supplement and Health Education Act of 1994 Assuring safety; guidelines for literature displayed where supplements are sold Provide use of claims and nutritional support statements Require ingredient and nutrition labeling Grant the FDA the authority to establish good manufacturing practice. What is the FDA? The FDA is a group provided and funded by the government of the United States known as the Food and Drug Administration. The FDA was established to protect the American people from foreign foods, diseases, and drugs that could harm the American people. The FDA also conducts clinical trials on pharmaceuticals before they are released to the general public Dietary Supplements Dietary Supplements A dietary supplement, also known as food supplement or nutritional supplement, is a preparation intended to provide nutrients, such as vitamins, minerals, fatty acids or amino acids, that are missing or are not consumed in sufficient quantity in a person's diet. Some countries define dietary supplements as foods, while in others they are defined as drugs. Hydroxycut Commercial http://www.youtube.com/watch?v= B8BeGgT1v5M Hydroxycut Thermogenic compund- aids your body in burning more fat by raising your metabolism Made of Natural and Laboratory Ingredients Ingredients Garcina cambogia Chromium Polynicotinate Gymnema sylvestre Oolong Tea Side Effects • Rapid Heart Rate •Itching • Hypertension •Difficulty swallowing • Seizures •Wheezing • Tachycardia •Insomnia • Difficulty breathing •Constant dreams • Anxiety •Acne on back and chest • Arrhythmia •Blurred vision • Heart palpitations •Weak jaw Case Study Procedure Subjects Workout program User Subjects Ag e Height (cm) 180.3 cm Weight (kg) (pretesting) 81.2 kg Body Fat % (pretesting) 16.75% Weight (kg) (posttesting) 80.7kg Body Fat % (posttesting) 17.66% Hydroxyc ut 1 Hydroxyc ut 2 Hydroxyc ut 3 Hydroxyc ut 4 Mean + S.D. 22 22 180.3 cm 70.3 kg 7.0% 69.9 kg 6.6% 23 174.0 cm 84.4 kg 15.4% 84.6 kg 13.7 % 22 176.5 cm 74.8 kg 12.9% 75.1 kg 14.5% 22. 25 + 0.5 177.8 cm + 3.1 77.7 kg + 6.33 13.01% + 4.31 77.6kg + 6.43 13.12% + 4.66 Table 2. Results of bioelectrical impedance testing before and after a three-week training period with Hydroxycut supplementation. Non-User Subjects Non-user 1 Non-user 2 Non-user 3 Mean + S.D. Age Height(cm) Weight (kg) (pretesting) 22 182.9 cm 88.5 kg 22 186.7 cm 98.9 kg 22 182.9 cm 93.9 kg 22 184.16 + 93.7 kg + 2.19 5.2 Body Fat % (pre-testing) 12.9 % 21.7 % 19.7% 18.1 % + 4.61 Weight (kg) (posttesting) 86.72 kg 99.8 kg 92.2 kg 92.9 kg + 6.6 Body Fat % (post-testing) 10.8% 23.1% 18.2% 17.37% + 6.19 Table 3. Results of bioelectrical impedance testing before and after a three-week training period where Hydroxycut was NOT supplemented. Is it Worth the Risk? NO! This study proves Hydroxycut to be ineffective. Therefore,in our opinion, the only weight loss that may occur with individuals who use the product would be those affected by the placebo effect. This brings on the question; if the pill does not help with weight loss, why risk any health problems? Seems to be nothing more than an economic breakthrough. Future Implications In the future the FDA should need to put government-imposed regulations on all dietary supplements. For instance, the labeling should be clearly stated and the side effects should be clear to the consumer before purchased. Just because dietary supplements claim they are all natural and non-addictive does not mean they do not have dangerous long-term side effects. As our research shows, dietary supplements are not regulated enough and prove to be dangerous under the FDA’s standards. If the FDA is meant to protect and make consumers aware of harmful substances then dietary supplements should be more closely studied and researched by the FDA.