The Washington Weather Report

The Washington Weather Report

by Beth Clay

The dietary supplement industry is facing a series of stormsin Washington this year, best known as SB 722 and HR 3377. The first storm wasweathered, and kept Sen. Richard Durbin (D-Ill.) from tacking SB 722 onto anAppropriations Billlargely because of the early predictions by industryinsiders watching the positioning of Durbin and others, but also because a coregroup of individuals got very busy early on in fighting this storm.

It is obvious that the second half of the 108th Congress willbe as critical to this industry as it was in 1994. If Reps. Henry Waxman(DCalif.) and John Dingell (D-Mich.) achieve their goalscreating a divisionbetween single-agent vitamin products and combination and botanical products,mandatory adverse event reporting with possible post marketing surveillance, andpre-market approval for many productsthe industry is looking at significantlyhigher prices for supplements and a death knell for many companies. Higherprices mean those who need supplements the mostindividuals who are strugglingfinancially or are on limited incomes, such as the elderlywould no longer beable to buy products and may suffer declining health as a result. Lost jobs meana burden on an already strained U.S. economy.

Durbin has not given up his battle; rather, he continues torail in the media, spreading misinformation about the extent of the legislationhe has introduced. According to the senator, products such as calcium, vitaminsC and E, and Flintstones vitamins would not be affected. However, if there hasever been one serious adverse event reported for calcium, Flintstones vitaminsor vitamins C and E, then these products would be subject to enforcementactions, which are extremely subjective and can include banning of the productoutright and mandatory post-marketing surveillance, which can be indefinitelyextended from the original three years if the Food and Drug Administration (FDA)deems it necessary.

SB 722 and HR 3377 are not in the best interest of theAmerican people. A recent survey showed 85 percent of Americans used dietarysupplements in 2003, with about 70 percent doing so regularly. A study publishedin December showed vitamin D and calcium work together to prevent colon cancer,but only in higher doses. Other studies continue to substantiate the importanceof protecting access to dietary supplements.

It is absolutely essential the industry leadership remainactively engaged in working with trade associations and the newly formedCoalition to Preserve DSHEA (Dietary Supplement Health and Education Act). Thereis strength in numbers. There is also strength in a unified message. I havespoken to numerous company executives in recent months who have not yetcommunicated with their own legislators and have not participated in the tradeassociations. I have been around politics all my life and actively engaged inthe federal legislative process for the last dozen years. Your customers, the grass roots, need youthe grass topstohelp them preserve their freedom to access dietary supplements. Getting involved and staying involved is essential. Companiessuch as General Nutrition Co. (GNC) have already engaged in activities to informtheir customers of pending legislation. Project FANS (Freedom of Access toNutritional Supplements) (www.projectfans.org) has been active in getting theword out on the radio and television. Such actions won the day during theappropriations process because most senators have been receiving lots of mailfrom their constituents and most offices have been visited by industryleadership. This activity needs to continue in the Senate, as well in the Houseof Representatives.

In my conversations with legislative staff and electedofficials, those who have been contacted by their constituents in the industryare obviously more knowledgeable about the true regulatory framework and aremore likely to want to preserve DSHEA.

SB 722 and HR 3377 should be opposed en bloc. Only byworking together are we going to achieve success.

Beth Clay is president of BC & A International LLC, anintegral health consulting and government relations firm. Prior to formingBC&A, Clay led Rep. Dan Burtons health care oversight activities on theHouse Committee on Government Reform and the Subcommittee on Human Rights andWellness. She can be reached via e-mail at [email protected].

Editors Note: INSIDER welcomesindustry commentary and letters to the editor. Direct your comments to HeatherGranato, group editor, 3300 N. Central Ave., Ste. 2500, Phoenix, AZ 85012, FAX(480) 990-0819, [email protected]. Letters may be edited for content or clarityand do not necessarily represent the views of Virgo Publishing or INSIDER.