`U.S. FDA Warns Company Over Olive Oil-Related Claims - Olive Oil Times

U.S. FDA Warns Company Over Olive Oil-Related Claims

Feb 18, 2014 9:21 AM EST
Julie Butler

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A recent U.S. Food and Drug Administration warn­ing let­ter is a sober­ing reminder for dietary sup­ple­ment com­pa­nies to be care­ful in the claims they make online about their prod­ucts.

The let­ter last month to Pennsylvania-based Exclusive Supplements raised issues includ­ing that the FDA con­sid­ers ther­a­peu­tic claims on the company’s web­site about its BioRhythm brand Olio prod­uct — which con­tains extra vir­gin olive oil — showed it was intended for use as a drug, and was an unap­proved new and mis­branded drug.”

Cholesterol-low­er­ing claim among those cited by FDA

The FDA said exam­ples of the web­site claims pro­vid­ing evi­dence BioRhythm Olio is intended for use as a drug include:

- Supports reduc­tion of bad’ cho­les­terol”


- Research indi­cates a diet that includes olive oil yields less over­all dis­ease and lower mor­tal­ity rates”

The online claims estab­lish the prod­uct is a drug because it is intended for use in the cure, mit­i­ga­tion, treat­ment, or pre­ven­tion of dis­ease,” it said, and intro­duc­ing or deliv­er­ing such prod­ucts for intro­duc­tion into inter­state com­merce for such uses vio­lates the Federal Food, Drug, and Cosmetic Act (Act).

Drugs’ need prior FDA approval

The FDA said BioRhythm Olio — which also con­tains omega fatty acids and con­ju­gated linoleic acid — was not gen­er­ally rec­og­nized as safe and effec­tive for the above uses and was there­fore con­sid­ered a new drug” under the Act. New drugs require prior approval from the FDA, which approves new drugs on the basis of sci­en­tific data show­ing they are safe and effec­tive.

It also said that it was offered for con­di­tions that are not amenable to self-diag­no­sis and treat­ment by indi­vid­u­als who are not med­ical prac­ti­tion­ers; there­fore, ade­quate direc­tions for use can­not be writ­ten so that a layper­son can use the drug safely for its intended pur­poses.” Thus the prod­uct is mis­branded because its label­ing fails to bear ade­quate direc­tions for use.”

Firms can con­tract out man­u­fac­tur­ing but not respon­si­bil­ity

Furthermore, the FDA said that even if the Olio prod­uct did not have ther­a­peu­tic claims which made it an unap­proved new and mis­branded drug, it would be con­sid­ered an adul­ter­ated dietary sup­ple­ment” because it was pre­pared, packed, or held under con­di­tions not meet­ing the Current Good Manufacturing Practice (CGMP) reg­u­la­tions for dietary sup­ple­ments.

As a dis­trib­u­tor that con­tracts with other man­u­fac­tur­ers to man­u­fac­ture dietary sup­ple­ments that your firm releases for dis­tri­b­u­tion under your firm’s name, your firm has an oblig­a­tion to know what and how these activ­i­ties are per­formed so that you can make deci­sions related to whether the prod­ucts con­form to estab­lished spec­i­fi­ca­tions and whether to approve and release the prod­ucts for dis­tri­b­u­tion,” the FDA said.

Although your firm may con­tract out cer­tain dietary sup­ple­ment man­u­fac­tur­ing oper­a­tions, it cannot…contract out its ulti­mate respon­si­bil­ity to ensure that the dietary sup­ple­ment it places into commerce…is not adul­ter­ated…,” it said.

Tweets and Facebook likes’ also fair game

NutraIngredients-USA online news ser­vice said other FDA warn­ing let­ters have also shown that reg­u­la­tions cov­er­ing health claims don’t apply only to prod­uct labels but also to web­sites, and that the FDA scru­ti­nizes activ­ity on Twitter and Facebook as closely as it does busi­ness web­sites. In one case the FDA said a com­pany had effec­tively endorsed an unau­tho­rized drug claim when it liked’ a con­sumer tes­ti­mo­nial on its Facebook page, it reported.

Exclusive Supplements, Inc. pres­i­dent Mark Mangieri told Olive Oil Times that the specifics the FDA cited were imme­di­ately removed from the biorhythm.us site and a revised descrip­tion of the ben­e­fits of sup­ple­men­tal olive oil are cur­rently being con­sid­ered.”

Although there is com­pelling research as to the var­i­ous health ben­e­fits of olive oil, we as a food and sup­ple­ment indus­try must be mind­ful of how and where that infor­ma­tion is com­mu­ni­cated,” he said.


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