Dietary Supplements Kaley McNay – Anda Shiarla –Nathan Sparks

Weight Loss Drugs Kaley McNay – Anda Shiarla –Nathan Sparks

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Up Until the 1930’s…

Legislation to protect consumers 1906 – Pure Food and Drugs Act (spawned FDA) was eventually ruled unenforceable for therapeutic drugs 1912 – Shirley Amendment made patent medicine fraud prosecutable, still nearly unenforceable as actual fraud had to be proven 1938 – Food Drugs and Cosmetics Act gave FDA more power over therapeutic drugs, added pre-market approval 1951 – Humphrey Durham Amendment 1962 – Drug Amendments now made it so drugs had to be safe and effective Laws since the 1960’s

Companies in Trouble  Trimspa  Fined $1.5 million by the FTC  Claims not supported by scientific evidence  CortiSlim  Surrendered assets worth $12 million to settle FTC charges  False claims of weight loss

Companies in Trouble  Bayer  Fined $3.2 million by the FTC  Violated order by FTC requiring scientific evidence  USA Prescriptions Inc.  Weight Watcher’s sued the software company  Pop-up ads for diet pills on Weight Watcher’s website  Deceived the customers

Dietary Supplements  Ingredients  Thyroid extracts  Acts like human thyroid hormones  Increase metabolism  Fat burners  Raise metabolism  Break down body fat  Ephedra  Originally used for asthma  Similar to amphetamines  Side effects  Heart attacks  Anxiety  Vomiting  Difficult urination  Manic episodes  Insomnia  Seizures  Racing heart  Kidney failure/stones  Severe headache  Death

Facts  Voluntary reports of adverse reactions  180 deaths linked to herbs and supplements over the past few years  Herbal supplements not regulated by the FDA  FDA will wait until it receives reports of problems caused by supplements before it can investigate and ban a dietary supplement

Ephedra Supplement Lawsuits  Misleading / deceptive advertising  Did not mention health risks (Xenedrine)  Increased blood pressure  Irritability of the heart  Heart conditions and death  Cytodine Technologies contends:  17 times faster  Strength, energy, and endurance

Baltimore Orioles pitcher Steve Bechler -Died February 17 at age 23 -Collapsed at spring training

 Ehedra banned by NFL, NCAA, and IOC  Baseball commissioner advising against use of products containing Ephedra  Want company to include health risk information in supplement ads  Warning labels: heart attack and strokes  Warning regarding warm weather  U.S. Food and Drug Administration  100 deaths linked to supplement

 Full ban  The standard that companies can't market dietary supplements "that pose a significant or unreasonable risk of illness or injury" still stands  The company has no immediate plans to begin selling the supplement again  Cytodyne Technologies stated:  It's not a coincidence that at this time the prosecutors have decided to file these allegations, given the current sensationalized climate surrounding ephedra."

Takeaway  As retailers move more into branding their own products, risk from product failure, from potentially false claims, and from consumer safety issues needs to be considered.  Damage from one product issue no longer just affects one product, but may affect the retailer’s other store brands and the retailer itself (consumer backlash)

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