Judul : Dietary Supplement Health And Education Act
link : Dietary Supplement Health And Education Act
Dietary Supplement Health And Education Act
mr. mizer: good afternoon. i am benjamin mizer,the principal deputy assistant attorney general for the civil division at the united statesdepartment of justice. we are here today to explain critical steps the federal governmentis taking to stem the tide of unlawful dietary supplements being sold to consumers nationwide.almost every day new sources on the internet, television, and in print feature stories aboutthe dangers of dietary supplements: a supplement
Dietary Supplement Health And Education Act, is laced with an undeclared pharmaceuticalingredient. a study is released about adverse health effects of a so-called natural remedy.an athlete or a member of the military falls ill after taking an untested energy product.these stories arise across the country all too often.consumers turn to supplements when they want
to lose weight, get an edge in athletic performance,or improve their overall well-being. from california to maine consumers ingest pills,powders, and liquids every day not knowing whether they are wasting money or whetherthey may end up harming, rather than helping, themselves.unfortunately, many of these products are not what they purport to be or cannot do whatthe distributors claim they can do. in some instances, consumers might be choosing supplementsover other proven therapies for serious conditions under the mistaken belief that these productscan help. i'm honored to be joined at the podium todayby my colleagues from the federal trade commission, the food and drug administration, the u.s.postal inspection service, the department
of defense, and the united states anti-dopingagency. today we are announcing a sweep of actionstargeting unlawful dietary supplement makers and marketers. over the past year we havepursued civil and criminal cases against more than 100 makers and marketers of dietary supplementsand similar products. a centerpiece of the sweep announced todayis the indictment of usplabs relating to widely popular workout and weight loss supplements.best-selling dietary supplements like jack3d, oxyelite pro, and oxyelite pro new formulaand advanced formula raked in hundreds of millions of dollars in sales.as alleged in the indictment unsealed today, the defendants were on a perpetual searchfor the next miracle ingredient. that search
generally focused on chinese chemical manufacturers.when they found an ingredient that they believed was promising, and knowing full well how themarket for dietary supplements worked, they doctored packaging, labeling, and other paperworkto defraud others about what the product was. much of the alleged fraud focused on the defendants'claims that their products were made from natural plant extracts. in truth, as one defendantput it, "lol, stuff is completely, 100 percent synthetic." these fraudulent claims ensuredthat the synthetic chemicals entered the united states, got on store shelves, and were purchasedby consumers. as alleged in the indictments, the defendantfalsified paperwork to stay off the radar of regulatory agencies both when the productscrossed the border and as they circulated
in commerce. they made misrepresentationsto convince well-known retailers who had concerns about untested synthetic materials to selltheir products. they falsified labeling and marketing materials to convince consumerswho prized natural ingredients to buy their products.all of these people -- regulators, retailers, and consumers -- trusted that the defendantswere telling the truth about their products. all of these people were deceived. this deceptionput lives at risk. the indictment describes the safety testingor, more accurately, the lack of safety testing that the defendants undertook before hockingtheir factory-made supplements. for instance, the indictment alleges that the defendantssometimes tested the products on themselves
and sold the ones that made them feel good.with one product the defendants allegedly recognized that the substance could potentiallycause liver toxicity, yet without conducting a single test to determine whether the substancewas safe they went ahead and sold it, working from the baseless assumption that they werenot using enough of the toxic substance in their products to cause problems, but therewere problems. there was an outbreak of liver injuries allegedlyassociated with the oxyelite pro new formula. consumers experienced jaundice. several neededtransplants to save their lives. how did the defendants respond? as the indictmentalleges, they promised the fda and the public that they would stop distributing the productat issue, but they did not. instead, they
undertook a surreptitious, all hands on deckto sell as much of the product as they could. we are here today in part to take an importantstep in holding usplabs accountable for its actions. the indictment unsealed today chargesusplabs in texas, four of its executives, and one of its consultants with a series ofcrimes associated with the sale of dietary supplements.charged with these defendants is sk laboratories based in southern california which manufacturedmany of usplabs' products, and one of sk labs' executives.as noted, this is just one step. whatever the outcome, i'm confident that the dedicatedmen and women from the department of justice and the special agents from the fda and irscriminal investigation who have worked so
hard to bring us to this point will ensurethat justice is served. the allegations against usplabs and its operatorsshould serve as a wake up call to the supplement industry. the unmistakable message is thatthe department of justice and its federal partners will be vigilant when it comes tothe health and safety of the american public. fighting illegal activity in the dietary supplementindustry is a high priority of our consumer protection agenda. the usplabs case announcedtoday is only one of the many cases brought as part of the sweep that we are unveiling.for the past year law enforcement and regulatory officials have focused efforts on many additionalproducts that cause high levels of concern among health officials nationwide.many of the cases that we have brought relate
to products that misrepresent the ingredientsthey contain. we have also brought cases involving products that make unsupported claims abouttheir effects. in numerous matters, the defendants are sellingproducts online through websites and touting their products to consumers for the cure,treatment, and prevention of diseases that range from cancer, to alzheimer's disease,to herpes. making these disease cure claims defines theseproducts as drugs under the law, and even though they were warned by the fda, and insome cases through joint letters with the ftc, to stop making such claims, a numberof the individuals and companies at issue continued to make these claims and promotetheir products as treatments or cures for
diseases; yet these drugs lacked substantialevidence of safety and effectiveness. they're also being sold without adequate directionsfor their use. therefore, selling them in interstate commerce in these circumstancesis illegal. the government is taking a multifaceted approachto combating the problems of unlawful dietary supplements. in addition to criminal actionswe are using civil and administrative tools to safeguard consumers from harmful products.as part of the sweep announced today, the justice department brought a dozen civil actions,including just five in the last week, under the food, drug, and cosmetic act, and in somecases using the civil mail fraud injunction statute, seeking to stop the defendant entitiesand individuals from violating the law.
in these cases we are asking the courts toorder the defendants to stop their illegal conduct and to put in place processes andprocedures to prevent them from violating the law in the future. our partner agencies,including the ftc, the fda, uspis, dod, and usada, are taking other measures both to enforcethe law and to educate the public. as i mentioned, i stand here in partnershipwith other agencies with whom we have joined forces to address this problem. through enforcementand education each agency is performing its own mission to protect consumers, and servicemembers, and athletes from dangerous, ineffective products.you will hear more from my colleagues about the actions their agencies are taking. together,through cooperation and teamwork, we can multiply
the impact of our efforts. these efforts won'tput an end to this widespread problem, but they will go some distance toward bringingchange to the industry. we are not here to criticize the entire supplementmarketplace. not every supplement contains an undisclosed ingredient, not every labellies about what is contained in the bottle, and not every claim about dietary supplementsis unsupported by scientific evidence, but consumers must be on guard before taking dietarysupplements. oftentimes it may be difficult or impossibleto tell the conditions under which the supplements are manufactured, and it is challenging tosort through real scientific substantiation for a product as compared to unsupported hype.how can consumers perform their own due diligence?
talk to your healthcare provider. ask thephysician whether the bottle that you see on the store shelf or on the internet willcause you harm or whether the money you're going to spend on it is worth it.consult the public education materials provided by ftc, fda, dod, and usada. the fda's website,for example, includes tips for making informed decisions in evaluating dietary supplements,and the ftc's website also contains a wealth of information.the department of defense and usada have developed extraordinary tools, including a cell phoneapp, to help consumers make informed choices about supplements.this is only the beginning. thanks to the partnerships we've built, our efforts in thisarea will continue. we will keep investigating
violators and we will use all available toolsat our disposal to advance our enforcement goals and to protect consumers.with that, i'd like to turn the podium over to my colleague deputy commissioner for globalregulatory operations and policy, howard sklamberg, of the food and drug administration.mr. sklamberg: thank you. dietary supplements are one of the most challenging areas thatfda regulates. this arena encompasses a vast array of products and has a complicated supplychain. we see a number of serious issues with dietary supplements and products falsely marketedas dietary supplements, including companies not adhering to good manufacturing practicesand products with hidden pharmaceutical ingredients, both of which have the potential to causesafety issues.
we also find products making false claimsthat are in violation of our laws. some examples include products that claim to treat seriousdiseases such as cancer or alzheimer's. we find that a company using one name and onesupply chain can change course the very next day, switch its name, and we're back to squareone, but we take vigorous enforcement action. recently, the fda took action to prevent additionaldeaths from the use of pure powdered caffeine, a dangerous product that has already resultedin the known deaths of two young men. indeed, during the past several years we'veissued hundreds of warning letters, worked with firms to voluntarily recall products,and pursued civil and criminal enforcement against persons marketing illegal products.in addition, the agency works with firms to
achieve voluntary compliance such as removingviolative claims, destroying unsafe inventory, and ceasing distribution. we leverage resourcesacross the agency, but still have to prioritize our efforts to maximize impact, focusing firston safety concerns. we're also working with our government partnerssuch as the department of justice, the federal trade commission, states attorneys' general,and with members of industry who have a strong vested interest in seeing bad actors heldaccountable. consumers should be mindful of scams in whichproducts claim to prevent, treat, or cure diseases or other health conditions but arenot proven safe and effective for those uses. these health fraud scams lead to delays ingetting proper diagnosis and treatment and
waste money. and these scams can also causeserious, or even fatal, injuries. today's joint agency effort is a testamentto our commitment to protecting consumers from potentially unsafe dietary supplements.the criminal charges against usplabs should serve as notice to industry that if your productsare found to be severely harming public health, the fda will exercise its full authority underthe law to bring you to justice and to protect consumers.thank you. with that, i will introduce acting deputy chief inspector gary barksdale of theu.s. postal inspection service. mr. barksdale: thank you. so as he said, myname is gary barksdale. i'm the acting deputy chief for the united states postal inspectionservice.
on friday, as part of a nationwide sweep ondietary supplement marketers, postal inspectors executed federal search warrants in ocala,florida. today, two additional search warrants were served in hyannis, massachusetts andlos angeles, california. at all three locations postal inspectors seizedevidence to support mail fraud charges and food and drug charges against the companiesdoing business as vibrant life, viruxo, optimum health, and regeneca worldwide.despite legitimate medical breakthroughs, scammers, like the companies i just mentioned,continue to peddle worthless pills, oils, and ointments, promising miracles and defraudingour postal service customers and the american public. it's the mission of the postal inspectionservice to enforce the laws that defend the
nation's mail system from illegal use.in the outlined scheme, victims lose their money by ordering a product that promises,but doesn't deliver. victims are also expecting certain health improvements by using the product,but their health suffers when none of the advertised claims actually work, and it caneven pose health risks. postal inspectors have a long history of effectivelyenforcing the mail fraud statute to halt scammers from using the mail to sell their wares tounsuspecting citizens. working with our law enforcement partners and our regulatory partners,we hope to protect the american consumer by keeping these scams at bay through our multi-prongedapproach of prevention, education, and prosecutive action.so with that, i'd like to turn the podium
over to acting director reilly dolan fromthe federal trade commission. mr. dolan: thank you very much. again, myname is reilly dolan and i am the acting deputy director for the ftc's bureau of consumerprotection. like to thank our colleagues at the department of justice and our other agenciesfor organizing and participating in this initiative. we are pleased to participate, as part ofthe ftc's ongoing consumer protection mission, to combat deceptive and unfair marketing practicesin connection with dietary supplements, and as part of that we are announcing three newactions, one complaint, and two recent settlements, 20 warning letters, to go along with 11 othercases the ftc has announced within the last year.according to the nutrition business journal,
americans spend nearly $40 billion a yearon dietary supplements. many deliver what they promise, but unfortunately, some supplementsare nothing more than 21st century snake oil. disreputable companies are always on the prowlto capitalize on changes in demographics, new public health scares, and growing epidemics.our law enforcement actions announced as part of this initiative reflect the false claimswe've seen recently: supplements marketing to an aging demographic to stop memory declineor graying hair, weight loss pills targeting the growing percentage of people who are battlingobesity, and even herbal remedies seeking to profit off an epidemic of opiate drug addiction.today we filed a complaint in federal district court seeking a permanent injunction and otherrelief against sunrise nutraceuticals for
its marketing of elimidrol, a concoction ofvitamins, minerals, and herbs purported to alleviate the terrible physical and mentalsymptoms of opiate withdrawal. sunrise said elimidrol allowed addicts toget and stay clean on the first try but, as alleged in the ftc complaint, they didn'thave the science to back up that claim. still, they charged $75 a bottle for the product.the company targeted vulnerable consumers who were trying to get clean, using movingtestimonials from addicts who claimed that elimidrol had saved their lives.we also are announcing recent settlements obtaining injunctive and monetary relief froma number of individuals and companies involved in two different weight loss scams.in the health nutrition matter we settled
with several defendants involved in a classicweight loss scam promising rapid, dramatic weight loss with bogus experts and fake scientificstudies. the products were named "weight-b-gone" and "quick and easy".in the second matter in npb we reached a settlement with several companies and individuals whocapitalized on the green coffee bean diet fad, a fad first touted on the dr. oz show.in this case, the ftc alleged the defendants launched the pure green coffee extract justweeks after the dr. oz segment aired and alleged false weight loss claims in news stories postedon the web. marketers must understand and comply withthe basic requirements that claims must be truthful, accurate, and supported by solidscience. the ftc will continue to be an active
enforcement presence in the enormous dietarysupplement marketplace. for those who don't, we will prioritize cases that serially affectconsumer health or safety or prey on vulnerable populations.however, law enforcement alone cannot solve this problem. if you're looking for a dietarysupplement to improve your health, you're going to have to wade through an awful lotof misleading advertising. be skeptical about -- for supplements thatclaim to cure diseases, reverse the signs of aging, cause weight loss without diet orexercise, or tout miracle cure or scientific breakthrough, talk to your healthcare professionalabout supplements you're considering, and please visit ftc.gov/dietarysupplements forthe materials that were referenced earlier.
now i'd like to introduce dr. david smith,the deputy assistant secretary for defense for health, readiness, and policy oversight.dr. smith: well, good afternoon. i'm here today representing the department of defense,and more specifically the military health system. and many of you may be aware thatthe military health system is responsible for medical care for more than 9.5 millionbeneficiaries around the world, including active-duty service members and their families,retirees, reserve and national guard beneficiaries. and i want to say that the dod and the militaryhealth system is in full cooperation and support with the department of justice and their initiativeto curb the use of unsafe dietary supplements. and ensuring the readiness of the force isone of the department's top goals, and unsafe
dietary supplements are a threat to readinessin the dod. now, why do i say that? well, more than 70percent of active duty service members take some type of supplement. and we also knowthat 20 percent of those take performance-enhancing, body-building, or weight-loss supplements.some dietary supplements, including some performance-enhancing and body-building supplements, may be unsafe,according to the fda. and our overall goal is to keep our servicemen fit to serve.and in december of 2011, dr. jonathan woodson, my boss and the assistant secretary of defensefor health affairs, asked to have a dod-wide initiative created to promote education indietary supplements, which resulted in the development of a project called operationsupplement safety, or opss, and the consortium
of health and military performance, champ,at our medical school, the uniform services university of the health sciences, leads opss.and the operation supplement safety, or opss, website is our go-to resource in the dod forinformation about dietary supplements. and since 2012, the opss team has developed manyproducts to educate our service members, leaders, family members, providers, and retirees onhow to choose supplements wisely. and champ, this dod center of excellence for health andmilitary performance, and the u.s. anti-doping agency, have also partnered since that timeto develop additional educational resources for opss, or operation supplement safety.and they released the opss high-risk supplement list in february of this year.and today, this partnership, along with funding
from the u.s. army comprehensive soldier andfamily fitness program, have produced two additional educational products that werebeing released today: one, an online interactive educational module called get the scoop onsupplements; and a mobile application that allows mobile downloading of our high-risksupplement list. and these new products are now available on the opss website to anyonethat wants to access that. the dod is proud to participate in the dietarysupplement sweep, alongside our federal agencies here today, and to address that issue of unlawfuland potentially unsafe dietary supplement products being marketed to our service membersand to our citizens. we applaud the team for taking on this clearpublic health issue for the nation. thank
you.and now it's my pleasure to introduce dr. amy eichner, who is the special advisor ondrug and supplements of the u.s. anti-doping agency.dr. eichner: hi. my name is dr. amy eichner. i'm from the u.s. anti-doping agency, andi'm the special advisor on drugs and supplements. i am here on behalf of usada and clean athletesto fully support the enforcement actions announced today. elite athletes, but all athletes, includingrecreational level, youth athletes, masters athletes, even the kids on playing fieldsin your neighborhoods are very heavily targeted by dietary supplement companies wanting tosell their products, especially sport and performance-enhancing products.the actions announced today are a real win
for clean athletes. we will continue workingwith the federal agencies to share information about risky products as we become aware ofthem, and we will also continue to directly educate u.s. athletes and the general publicon the dangers of the dietary supplement industry, and provide guidance on how people can choosesafe supplements. we offer this education on our supplement411.orgwebsite, on which we also host the usada supplement-411 high-risk list. the high-risk list is a listof products that are known to contain or advertise to contain substances prohibited in sport.for those of you who are familiar with the world anti-doping agency prohibited list,you will realize that nothing on that list has anything to do with nutrition. those substancesshould not be in dietary supplements.
i would also like to announce that we arealso launching the supplement-411 high-risk list application, similar to opss. so i inviteanybody who would like to view that to visit the apple store. it will be available in androidin two weeks time. i would also like to acknowledge our veryimportant partnership with the uniform services university. working together with that agencyhas strengthened all of our educational materials, and i can tell you this is just the beginning.again, we fully support the agencies here and the actions that they've taken today.thank you very much. mr. mizer: questions?(no audible response.) dr. eichner: well, if there are no questions,then --
(whereupon, at 3:59 p.m., the press conferencein the above-entitled matter was concluded.)
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