Overview: Supplements ! Dietary Supplements ! Ergogenic Aids

! Supplement Regulations ! DHEA ! Story of Ephedrine ! USP verification

! Red Flags for Deception ! Video clip: Bigger, Faster, Stronger

What are dietary supplements? ! Contains 1 or more of the following: Vitamins Minerals Herbs Amino acids (makes protein) Substance increases total dietary intake Concentrate, metabolite, constituent, extract or combo of any of the above. ! Many supplements marketed as ergogenic aids ! ! ! ! ! !

What is an ergogenic aid? ! A performance enhancing substance. ! A product used to enhance sports performance beyond the effects that could be obtained through training.

Dietary Supplements ! Do not have to prove they are safe ! Do not have to prove they are effective ! Product label may not contain all the ingredients in declared amounts ! Product may contain ingredients not listed

DSHEA - Dietary Supplement Health and Education Act ! A legislative act passed in 1994. ! Broadened the regulatory definition of dietary supplements ! Altered the federal government’s oversight of supplement products.

DSHEA Requirements ! Safety: Supplement company not required to test product for safety ! FDA can only step in if product proven to cause harm

! Effectiveness: Supplement company does not have to prove product does what it claims. ! Claims: “energy enhancer”, “builds muscle”, “boosts immune system” ! Not reviewed by FDA. Based on companies interpretation of scientific studies. ! Must include disclaimer

Disclaimer Statement “This statement has not been evaluated by the FDA. This product is not intended to diagnose treat, cure or prevent any disease”.

DSHEA Label Requirement ! Label must include Facts Panel & list of ingredients ! Appearance very similar to Nutrition Facts on food ! Food regulated by FDA; supplements are not

! May contain ingredients not on label, omit ingredients stated on label.

Challenge Question Which statement do you agree with? a)  Supplements are regulated by the FDA. b)  Supplements are tested for effectiveness prior to marketing the product c)  Supplements do not have to prove they are safe.

The Story of Ephedrine ! 1995: The FDA meet to discuss adverse events ! 1996: The FDA recommended warning labels ! 1997: Proposed rules for product ! 8 mg or less of ephedrine ! Label must state that product not used for more than 7 days

! 1998: The GAO began a study ! 1999: GOA concluded that ephedrine-containing supplements can cause serious health problems. ! 1999-2003: Many independent reviews. The RAND report identified 21 adverse events including stroke, heart attack and death.

The Story of Ephedrine ! 2003: GAO testifies – adverse outcome when followed recommended dose, frequency and duration. ! 2004: The FDA bans the sale of ephedra supplements ! 2004: Nutraceutical International Corporation sues -low doses of ephedrine have not been proven dangerous. ! 2005: U.S. District Court judge in Utah overturns ruling. Low dose Ephedrine products return to the market ! 2006: U.S. Court of Appeals overturns 2005 Utah ruling ! 2007: Nutraceutical International Corporation challenges in the U.S Supreme Court but denied. The ban of all products containing ephedrine upheld.

USP Verification Indicates: ! Contains amounts & potency of ingredients on the label ! Does not contain harmful contaminants ! Easily released into body ! LABEL DOES NOT MEAN: •  The product is effective •  The product is safe

Supplement Verification

Red Flags for Deceptive Products 1.  Does the claim sound too good to be true? 2.  Are claims supported with results from a single study or studies not published in scientific journals? 3.  Does the product promise quick improvement? 4.  Does it provide anecdotes or testimonials? 5.  Does the person recommending it, financially gain by your purchase? What are their qualifications? 6.  Does the product include a disclaimer statement?