Setting: All-Mart Mega Store, near Antinomos provincial capital, 19 April 2011.
Kanye Moody, MD, Outer MVTV medical journalist: “Last month my colleague Nima Amin visited this exact store, querying Antinomians about the impact of the recently enacted Repeal and Exemption of Advertising Policies, or REAP Law, upon their buying habits. We are here this busy Saturday afternoon with a slightly different probing intent: What do health-minded shoppers think in relation to the virtually eclipsed provision in REAP that removes the need for companies to demonstrate to the Food and Dietary Supplement Administration, or FDSA, the safety of new ingredient or finished goods, specifically foods, beverages, nutraceuticals, and cosmetics.” [Dr. Moody, approaching a lean, muscular, 30-something male consumer exiting the store] “Good morning. I’m Dr. Kanye Moody with MVTV. What’s your name, sir? “
Shopper: “Hi. My name is Shane Rodgers.”
Dr. Moody: “Nice to meet you, Shane. You look like you work out hard—you’re in great shape. Has REAP affected or influenced the way you shop for… [Dr. Moody pauses, looking into hand transporter pod] sports nutrition and energy products? I see you have a few here.”
Shane: “Not at all. I consider myself an educated consumer. I read a lot on the supranet, and I was a biochemistry major at university. I’m also the strength coach at Antinomont Prep School, so I have to know what’s out there because my guys hammer me with questions about what’s safe and what works.”
Dr. Moody: “Cool, Shane. I, too, was a biochemistry major before medical school. So then you are one of the very few, enlightened consumers who is aware that this [Moody gestures to place hand into transport pod]—may I? [Shane nods his head, affirmatively] …Torched Pre-Workout Energy Concentrate powder [Moody lifts product out of pod and MVTV camera frames it] contains an ingredient that was a drug 60 years ago, and in some animal studies was shown to be more lethal than ephedrine, and in higher doses—in humans—produces hypertension and mental confusion. [Camera focuses on Shane, who is visibly disturbed] And you recognize that the safety of this actual product—as you take it—is unknown, despite the ‘GMP Made’ seal on the top and sides?”
Shane [defiantly]:“I respect you but I think you’re mistaken, Doc. I’ve done my homework on this product. All of the ingredients are proven safe, and GMP means that the product is safe and effective. You’re going to have to show me some proof, especially about the ingredient that you said was MORE lethal than ephedrine.”
Dr. Moody [after being handed a binder]: “Shane, I respect your skepticism but here is the evidence [camera focuses on select scientific studies in the binder]. We, too, have done our homework. First, here are the studies showing one ingredient, purported to be an extract of geranium grown on Earth, is more lethal than ephedrine when given via injection in animals. Here is the human study showing this ingredient, when orally ingested, has hypertensive effects and creates mental confusion. Finally, here is the section of the FDSA law related to the manufacture of dietary supplements under Good Manufacturing Practices, or GMPs. Nowhere does it state that a finished product has to be systematically evaluated for safety, in hamsters nor humans, and REAP removed the requirement for pre-market safety validation. In fact, we contacted this company and they admitted they have no safety data on the actual product, in animals or humans.”
Shane:“Ouch, Doc. REAP paints a grim picture. I knew a lot less than I thought. Thanks for enlightening me. This is game changing…”
Nutraceuticals Multiverse: Energy Deficit
What if there were no regulations (and thus no enforcement) regarding nutraceutical ingredient or product safety?
By Anthony Almada
Published March 1, 2011