OUTRAGEOUS! FDA Overzealous Regulations May Cost You

OUTRAGEOUS! FDA Overzealous Regulations May Cost You

New regulatory threats, some at the urging of the pharmaceutical industry, could make it impossible for seniors to purchase certain products like vitamins and minerals without a prescription.  It may sound outrageous, but seniors could soon be limited in their access to things as simple as protein shakes, vegetable juice and even herbal hand lotion without a prescription.  The U.S. Food and Drug Administration (FDA) recently began imposing new regulations on products used in "Complementary and Alternative Medicine" (CAM).  TSCL is concerned the expensive federal regulations will restrict seniors' access to commonly available items and drive up costs for those that remain on the market.

In a draft of regulations the FDA gave the following example: "if a person decides to produce and sell raw vegetable juice for use in juice therapy to promote optimal health, that product is a food subject to the requirements for foods … including the hazard analysis and critical control point system requirements for juices.  If the juice therapy is intended for use as part of a disease treatment regimen instead of for general wellness, the vegetable juice would also be subject to regulation as a drug under the act."

According to the FDA, "Complementary and Alternative Medicine" encompass a wide array of health care practices, products, and therapies that are distinct from conventional medicine.  Examples include botanical and animal-derived extracts, vitamins, minerals, amino acids and proteins, just to name a few.  In addition there would be new regulations of medical devices used by alternate medicine practitioners like chiropractors, massage and acupuncture therapists.

TSCL believes the regulations could be costly to seniors and to Medicare.  Alternative therapy and medical approaches are used by millions of Americans.  The Centers for Disease Control and Prevention estimated, that the U.S. public spent between $36 billion to $47 billion on CAM therapies in 1997, an amount that was more than the U.S. public paid out-of-pocket for all hospitalizations in that year, and an amount that was approximately one-half of that paid by the U.S. public for all out-of-pocket physicians' services.

TSCL recently submitted comments on the draft FDA regulations, stating "classifying CAM products as drugs, the cost of access would increase, as consumers may have to visit and pay a doctor for a prescription, instead of being able to choose their own vitamins, minerals and dietary supplement intake."  TSCL is further concerned about the impact such regulation would have upon Medicare beneficiaries.  Currently, Medicare reimburses few CAM therapies and products and seniors must pay out of pocket.  Most Part D drug plans, for example, don't cover vitamins and supplements.  TSCL called on the FDA to withdraw the regulations.

Sources:  "Complementary And Alternative Medicine Products And Their Regulation By The Food And Drug Administration," FDA, December 2006.  "Complimentary And Alternative Medicine Use Among Adults: United States 2002," CDC, May 27, 2004.