FDA or­ders a halt to mouth­wash claims

It says the mak­ers of three prod­ucts as­sert health ben­e­fits that have not been proved.

Los Angeles Times - - The Nation - An­drew Za­jac re­port­ing from washington aza­jac@latimes.com

The Food and Drug Ad­min­is­tra­tion has warned three com­pa­nies that mar­ket mouth-rinse prod­ucts to stop mak­ing un­sup­ported claims that they re­move plaque and pro­mote healthy gums.

The claims sug­gest that the prod­ucts, which are used by mil­lions of Amer­i­cans ev­ery day, are ef­fec­tive in pre­vent­ing gum dis­ease when no such ben­e­fit has been proved, the FDA said Tues­day.

The agency said warn­ing letters were sent to John­son & John­son, maker of Lis­ter­ine To­tal Care An­ti­cav­ity Mouth­wash; and to two drug­store giants: CVS Corp., which sells CVS Com­plete Care An­ti­cav­ity Mouth­wash; and Wal­green Co., which sells Wal­green Mouth Rinse Full Ac­tion.

The letters are the lat­est in a stream of warn­ings is­sued to food and drug pro­duc­ers by the FDA and the Fed­eral Trade Com­mis­sion since Pres­i­dent Obama took of­fice deal­ing with un­sub­stan­ti­ated health ben­e­fits on la­bels and in ad­ver­tis­ing.

“We’ve got a much more ag­gres­sive FDA and FTC, there’s no ques­tion about it,” said John Vil­lafranco, a Washington at­tor­ney who spe­cial­izes in ad­ver­tis­ing and con­sumer pro­tec­tion is­sues.

Vil­lafranco said that in con­trast to Europe, where

‘It’s the act of rins­ing [that is ef­fec­tive in fight­ing plaque]. Sodium flu­o­ride doesn’t re­move plaque.’

— Jonathan Shenkin, pe­di­atric den­tist and as­sis­tant pro­fes­sor, Bos­ton Uni­ver­sity

School of Den­tal Medicine

reg­u­la­tors list per­mis­si­ble claims for food and drugs, “and you’re ei­ther on the list or you’re not, in the U.S. there’s been a more flex­i­ble stan­dard,” which now is be­com­ing less for­giv­ing.

Un­der U.S. law, a com­pany can­not as­sert that a prod­uct is ef­fec­tive in treat­ing a dis­ease un­less the claim has been ap­proved by the FDA, or the ac­tive in­gre­di­ent has been gen­er­ally rec­og­nized as safe and ef­fec­tive for the claim.

All three mouth­washes cited con­tain as their ac­tive in­gre­di­ent sodium flu­o­ride, which pre­vents cav­i­ties, but which the FDA has not­found to be ef­fec­tive in re­mov­ing plaque or pre­vent­ing gum dis­ease.

In the case of Deerfield, Ill.-based Wal­green,, the com­pany has claimed that its Mouth Rinse Full Ac­tion “helps fight vis­i­ble plaque above the gum line.”

Rins­ing does dis­rupt plaque, but the ef­fect is sim­i­lar with plain wa­ter or mouth­wash, said Jonathan Shenkin, a pe­di­atric den­tist and as­sis­tant pro­fes­sor of health pol­icy at Bos­ton Uni­ver­sity’s School of Den­tal Medicine.

“It’s the act of rins­ing. Sodium flu­o­ride doesn’t re­move plaque,” Shenkin said.

By mak­ing an un­proven med­i­cal claim, Wal­green es­sen­tially po­si­tioned its mouth­wash as a new drug, for which tests to prove safety and ef­fec­tive­ness would be re­quired, ac­cord­ing to the FDA let­ter to the com­pany.

A Wal­green spokesman said that “we are com­mit­ted to work­ing with the FDA on this mat­ter and will be re­spond­ing to their let­ter ac­cord­ingly.”

The warn­ing to John­son & John­son, of New Brunswick, N.J., fol­lows a string of reg­u­la­tory prob­lems over the last year, in­clud­ing re­calls of hip implants and con­tact lenses, plus a mas­sive re­call of Chil­dren’s Tylenol and other over-the­counter med­i­ca­tions that are the sub­ject of con­gres­sional and grand jury in­ves­ti­ga­tions. Re­gard­ing the mouth­wash com­plaint, John­son & John­son said in a state­ment that the com­pany “will re­spond to the agency in an ap­pro­pri­ate and timely man­ner.”

A spokesman for Woonsocket, R.I.-based CVS said the com­pany was re­view­ing the FDA’s let­ter, but “our pol­icy is to fully com­ply with all FDA la­bel­ing re­quire­ments.”

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