Ajph20113501_pomeranz 1.6SCIENTIFIC EVIDENCE, SOCIAL RESPONSIBILITY, AND GOVERNMENTAL INTERVENTION Over-the-Counter and Out-of-Control: Legal Strategies toProtect Youths From Abusing Products for Weight Control Abuse of widely available, Jennifer L. Pomeranz, JD, MPH, Lisa M. Taylor, JD, S. Bryn Austin, ScD over-the-counter drugs andsupplements such as laxa- ABUSE OF WIDELY AVAILABLE, control, including laxatives and with a clinical sample of patients tives and diet pills for weightcontrol by youths is well over-the-counter (OTC) drugs syrup of ipecac.9,13,14 OTC laxa- with eating disorders found that documented in the epide- and supplements such as laxatives tives are medically approved to 6% misused alli, most often in an miological literature. Many and diet pills by adolescents and treat constipation, but have re- effort to compensate for a binge such products are not med- adults for weight control is well ceived a fair amount of attention eating episode.20 documented as a national problem in the epidemiological and medical Despite the ineffectiveness and healthy weight control or in the United States in the epide- literatures because of their pre- potential harm of many products are especially susceptible miological literature.1,2 Many of valence of abuse. Based on their used and misused for weight con- to abuse, and their misuse these products are not medically review of more than 70 studies, trol, the global market for diet can result in serious health recommended for healthy weight Neims et al. estimated the lifetime management and weight loss control or are ineffective for prevalence of laxative abuse for products was estimated to be We analyzed the govern- weight loss, even in the short weight control to be 4% of the $363 billion in 2009 and is pro- ment's role in regulatingthese products to protect term.1,3--5 Abuse of these products general US population, affecting jected to reach $586 billion by public health. We examined affects both males and females many millions of Americans.15 Es- 2014.21 In addition, the sale of federal and state regulatory of all racial, ethnic, and socioeco- timates of the lifetime prevalence products not overtly marketed authority, and referred to in- nomic groups.1,6 The National of laxative abuse from studies of for weight loss but abused for ternational examples to in- Comorbidity Survey Replication, patients diagnosed with bulimia weight control generates millions form our analysis. Several a nationally representative study nervosa or eating disorders not of dollars each year. In 2008, total legal interventions are indi- of US households, found that 50% otherwise speciﬁed have ranged sales of OTC laxatives in the US cated to protect youths, in- of people with bulimia nervosa, from 15% to as much as 62%.16 In approached $290 million.22 It is cluding increased warnings a disorder often associated with a large, community-based sample signiﬁcant that OTC laxatives are and restrictions on access abuse of laxatives and diet pills, of adolescents, past-year use of substantially less expensive than develop the illness by age 18 laxatives for weight control pur- alli, and thousands of pills can be placement or age verification.
We suggest future di- years.7 Among US adolescents, poses was estimated to be 2% in purchased for a fraction of the rections for governments 6% of girls and 4% of boys re- girls and 1% in boys.6 price of alli.23,24 Both drug prod- internationally to address ported past-month use of diet In 2007, the US Food and Drug ucts are widely available in retail this pervasive public health products without physician ad- Administration (FDA) approved establishments, pharmacies, and vice.2 Serious health consequences the ﬁrst nonprescription diet drug, on the Internet, and both are Health. Published online can result from abuse of these orlistat, for OTC status. Orlistat is advertised directly to consumers, ahead of print December OTC products, such as acute and a weight-loss drug that prevents with the manufacturer of alli 13, 2012: e1–e6. doi:10.2105/ chronic impairment of gastrointes- the absorption of fat from food employing a celebrity spokesper- tinal and cardiovascular systems, and has a laxative-like effect.17 son in its advertisements.25 sometimes resulting in death.8 Ad- Prescription strength orlistat was In light of the epidemiological verse effects include dehydration, approved at 120 milligrams in evidence documenting the abuse chronic diarrhea and constipation, 1999 for obesity management, of OTC laxatives and the increas- metabolic acidosis, hypokalemia, and in 2007, the FDA approved ing concerns over potential misuse and other ﬂuid and electrolyte dis- orlistat 60 milligrams for OTC of alli, we obtained a pilot grant to orders; cardiac arrhythmia; hem- status under the name alli. Con- examine current US regulations orrhagic and ischemic stroke; and cerns about potential misuse and pertinent to these 2 OTC drug hepatic and renal failure.3,4,9--12 abuse of orlistat were raised by products. We analyzed the US Products and product cate- eating disorder experts upon its government's legal authority to gories that have been widely OTC approval18 and continue to increase regulation to address abused for weight control include be raised globally as the drug outstanding public health con- those explicitly marketed for such becomes more accessible interna- cerns. Available legal methods in- purposes, but also other products tionally.19 Studies are emerging to clude requiring warning labels and only believed to aid in weight support these concerns. A study regulating permissible locations Published online ahead of print December 13, 2012 American Journal of Public Health Pomeranz et al. Peer Reviewed Analytic Essays e1 SCIENTIFIC EVIDENCE, SOCIAL RESPONSIBILITY, AND GOVERNMENTAL INTERVENTION where such products may be sold.
including listing ingredients, ex- Government regulations that products that encourages the dis- We thus analyzed federal and planations of proper use, and require the disclosure of factual closure of weight-loss related in- state regulatory authority and warnings against unsafe use, side information are consistent with formation and product-speciﬁc looked to speciﬁc international effects and adverse reactions.29 the First Amendment of the US examples of countries with known Because no drug is absolutely risk- Constitution.35 Industry chal- In general in the United States, regulation of diet products to in- free, labels are intended to address lenges to disclosure requirements prescription drugs are adminis- form our analysis and provide outstanding concerns of harm, are generally only successful tered by a pharmacist and OTC context for the consideration of toxicity and conditions of safe use when the government has sought drugs can be sold in any retail alternative restrictions. We have to allow for OTC status.30,31 to require subjective information establishment on open shelves.
set forth this research and pro- Beyond basic instructions, the be placed on the product pack- The designation of speciﬁc drugs vided recommendations for in- FDA often establishes speciﬁc aging.36 Requiring purely factual as being available behind-the- warnings for products that may disclosures, warnings, and dis- counter (BTC) is a recent intro- cause harm under proper use, claimers have been upheld as duction to the US market. The REGULATORY AUTHORITY such as potential allergic reactions a valid use of government au- FDA and Congress have not cod- or organ damage.32 The FDA also thority to protect and inform iﬁed this "third class" of drugs to The FDA has regulatory au- has the regulatory authority to create an ofﬁcial designation, but thority over the safety, efﬁcacy, require warnings for a product The Federal Trade Commission the federal government has per- and labeling of prescription and when "foreseeable risks of harm is responsible for regulating the mitted or required certain drugs to nonprescription drugs. In 1951, posed by the product could have advertisement of OTC drug prod- be sold BTC for reasons directly the US Congress codiﬁed the dis- been reduced or avoided by the ucts. Advertisements for OTC relevant to the speciﬁc drug, the tinction between prescription and provision of reasonable instruc- drugs must be truthful and non- approved user, and public health OTC drugs. A prescription drug tions or warnings."33 For example, deceptive and manufactures must considerations.41 For example, reports in the medical literature have a "reasonable basis" for any the FDA granted the emergency and data accumulated by the FDA claim they make.38 If a claim re- contraceptive, Plan B, nonpre- because of its toxicity or other indicated that consumers were lates to health, safety, or product scription BTC pharmacy-only sta- potentiality for harmful effect, confused about proper dosing of efﬁcacy, it must additionally meet tus for women older than 18 years or the method of its use, or thecollateral measures necessary to sodium phosphate laxatives, the standard of "competent and in 2006.41 (The drug remains its use, is not safe for use except resulting in death, so the FDA reliable scientiﬁc evidence."39 prescription-only for those youn- under the supervision of a practi- required a warning stating that, This means that tests, studies, and ger than 18 years.) In a similar tioner licensed by law to admin-ister such drug.26 "Taking more than the recom- research must be objectively con- vein, Congress enacted a law re- mended dose in 24 hours can be ducted, based on accurate and quiring cold medicines containing This distinction is intended to harmful."34 Therefore, if misuse reliable procedures, and evaluated pseudoephedrine to be located both protect the public and relieve becomes reasonably foreseeable, by qualiﬁed people.39 The Federal BTC because of concerns over its pharmacists and the public from increased factual warnings are Trade Commission additionally use in illicit drug-making.42 The burdensome restrictions on dis- considered necessary to protect supports a set of voluntary guide- law limits the amount an individ- pensing drugs that are generally lines for marketers of weight-loss ual may purchase within a 30-day recognized as safe.27 The box onthis page deﬁnes dispensationterms.
Definitions of Terms Relating to Drug Dispensation The FDA has the authority to designate a drug as OTC or pre-scription but more frequently, OTC drug manufacturers can le- Behind the counter of any retail establishment (no pharmacist required to be on the premises) gally market drugs without preap- Behind the counter of pharmacies only (requiring contact with pharmacy staff) proval as long as they comply with Over-the-counter of any retail establishment (not requiring prescription or contact with the previously established OTC drug monograph, which typically Over-the-counter in pharmacies only but not requiring contact with a pharmacist lists acceptable ingredients and Requires physician prescription (only available in pharmacies and requiring contact with required labeling information.28 pharmacy staff to obtain drug) The FDA, therefore, does not re- Retail establishment Place that sells over-the-counter products view each OTC drug product or Place that sells over-the-counter products and prescription-only products; also called drug stores label but it does require a speciﬁcformat and content for OTC labels, e2 Analytic Essays Peer Reviewed Pomeranz et al.
American Journal of Public Health Published online ahead of print December 13, 2012 SCIENTIFIC EVIDENCE, SOCIAL RESPONSIBILITY, AND GOVERNMENTAL INTERVENTION period and requires photo identi- FDA.47 However, states can regu- A common OTC laxative ingredi- common health effects result from ﬁcation for purchase.43 late the practice of pharmacies,47 ent, bisacodyl, is OTC in Australia Considerations relevant to al- and this includes the ability to and the United Kingdom, but is Even with the addition of ap- tering the drug classiﬁcation sys- regulate the location of products, OTC pharmacy in Italy and the propriate labeling, laxatives may tem in the US, such as increased such as requiring OTC drugs to be Netherlands.44 Bisacodyl is also rightly be the focus of access re- costs or increased need for phar- located BTC. For example, New available for purchase online in strictions because some people macists,44 are outside the scope of York recently passed a law requir- 1000 pill count bottles for little who abuse laxatives engage in this article because the current ing that ipecac be located BTC.48 pervasive use despite knowledge analysis is limited to only 2 drugs.
Similarly, prior to the federal act, of potential harm or experiences However, it is noteworthy that several states enacted laws re- with poor health effects because the American Pharmacists Associ- quiring that pseudoephedrine- of their underlying disordered ation released a statement sup- containing products be placed eating behaviors.58--60 Unlike diet porting the development of a reg- BTC and several retailers volun- drugs, laxatives may be medically ulatory process for a third class tarily did the same.49 Now, 2 appropriate in a situation where of BTC drugs.45 Furthermore, states have enacted, and many OTC laxatives are medically in- time may be of the essence.
unlike the United States, other states are considering, laws that dicated only to relieve constipa- Therefore, a requirement that countries have multiple drug clas- require prescriptions to obtain tion but are misused by many as a laxatives be maintained BTC of siﬁcations. The US General Ac- misperceived method of weight pharmacies only may unreason- counting Ofﬁce conducted a study control. Epidemiological research ably hinder healthy users' access of nonprescription drug practices conﬁrms that a substantial portion when medically needed so less of select countries and found that CURRENT REGULATIONS of patients with eating disorders restrictive access restrictions may they include prescription, BTC FOR OVER-THE-COUNTER and other people seeking weight ultimately be indicated.
pharmacy, BTC, OTC pharmacy, control abuse laxatives. Research If increased labeling alone does OTC, and OTC but a pharmacist also indicates that young people not alter consumption patterns, must be present for consumer The FDA established a drug start abusing laxatives without or if an authoritative medical body consultation.44 For example, the monograph for OTC laxatives.51 knowledge of the enormous health determines that laxatives should United Kingdom follows a 3-tier Manufacturers may produce prod- risks. Because it is established from not be used by minors (younger drug classiﬁcation system (pre- ucts with the approved ingredients research that abuse and misuse than 18 years) without physician scription, BTC pharmacy-only, and must provide appropriate is reasonably foreseeable, the FDA or parental supervision, or that and OTC) that has been in place instructions for use, including should consider requiring warning minors are the primary or persis- since 1995. The European Union daily dosing.51 Except for FDA labels on these products.
tent over-consumers of laxatives, has a centralized approval process action on sodium phosphates, The lack of adequate instruc- the government might deem it but leaves to each member state there has been relatively little tions and warnings makes a prod- appropriate to regulate access to the decision to designate the loca- regulation of OTC laxatives and uct dangerous in light of the fore- laxatives. A speciﬁc method would tion of approved products among no required warnings associated seeable risks of harm posed by be to require that laxatives be sold the various classiﬁcations.44 Con- with their misuse. Perhaps be- the product.33 The FDA should from BTC in all retail establish- versely, in Australia each state and cause laxatives have been medi- consider amending the OTC laxa- ments and pharmacies to prohibit territory has the authority to de- cally utilized for centuries,16 little tive drug monograph to include the purchase of large quantities termine drug classiﬁcation inde- restriction has been placed on several requirements. First, the at a time. This stipulation could be pendently, but they have all adop- instructions on use should not only coupled with an age restriction ted the national scheduling orders, Only 1 US state has a restriction recommend daily dosage but to limit the quantity purchasable which include 4 classiﬁcations: related to dispensing laxatives should also indicate an appropriate prescription, BTC pharmacy, OTC and this is based on reports of duration of administration.54 Sec- Retailers of all types are re- pharmacy, and OTC.44 laxative abuse among individuals ond, in addition to a statement of quired to keep certain products In the United States, states and engaged in sports with weight re- the purpose for which such drug behind the counter, such as to- local governments (collectively quirements.16 In California it is is intended,55 the FDA should bacco for age veriﬁcation pur- states) cannot enact laws that a misdemeanor for a coach to give consider requiring a statement poses61 and pseudoephedrine conﬂict with federal law.46 In the laxatives to a minor for nonmedi- speciﬁcally noting that the drug is for quantity restrictions.43 Similar context of OTC products, this cal purpose, such as to lose weight not intended or effective for weight BTC requirements can be insti- prohibition includes warning and related to participation in control.56 Third, the packaging tuted for laxatives. Although this labeling requirements on packag- should include a warning that con- would not prevent consumers from ing and shelf signs that are not Internationally, there is also lit- sumers should "Stop use and ask purchasing many small quantities identical to those required by the tle regulation on OTC laxatives.
a doctor if" dependence or other from several establishments, such Published online ahead of print December 13, 2012 American Journal of Public Health Pomeranz et al. Peer Reviewed Analytic Essays e3 SCIENTIFIC EVIDENCE, SOCIAL RESPONSIBILITY, AND GOVERNMENTAL INTERVENTION a restriction could assist in deter- Union approved the switch from requirements. By simply doubling health literature, among other ring consumption and would relay prescription to nonprescription for the dose, consumers could take an disciplines, and suggests that efﬁ- the message that consuming large alli for use by adults with a BMI equivalent to the prescription cacy varies for different types of quantities of laxatives is harmful of 28 or higher.67,68 In the Neth- product without physician super- products and different outcomes to one's health. The revised loca- erlands, orlistat is OTC phar- vision. If evidence of misuse, assessed.75,76 But research does tion would impact only people at macy.44 In the United Kingdom abuse, or underage use accumu- indicate that individuals who read risk for abusing them and not those and Ireland, alli is classiﬁed as lates, the government might con- warning messages are more likely consumers who would purchase a BTC pharmacy drug and the sider requiring alli for BTC to comply with them and that the the proper amount for the medi- onus is on the pharmacists to pharmacy-only status. The BTC presence of the warning alone in- cally indicated use.
verify age and determine BMI designation is most relevant and creases the likelihood of hazard prior to sale.19,69,70 The manufac- appropriate for drugs that are reduction even when the danger is CURRENT REGULATIONS turer and pharmacy societies train prone to abuse or have age re- known.75 Importantly, studies the pharmacists in both countries strictions placed on their pur- show that consumers are likely to but consumer groups found that chase.41 BTC status would enable underestimate the risks associated The FDA approved alli (which a large percent of pharmacists age veriﬁcation. Pharmacy-only with products when a warning is is exactly half the dose of the were not verifying BMI prior to status could encourage customers not present.75 This ﬁnding is es- prescription-strength product) for dispensing alli. In Australia, orli- to consult a pharmacist. This is pecially pertinent to OTC laxa- OTC status for weight loss in stat is approved for BTC phar- pertinent because of the risk of tives, which carry no precautions overweight (deﬁned on the pack- macy status and indicated for persons doubling the dose to ob- or indications of adverse conse- aging as having a body mass index adults 18 to 74 years old with tain the prescription strength quences of misuse. In addition, [BMI, deﬁned as weight in kilo- a BMI greater than 30 or a BMI amount without physician autho- researchers found that adolescents grams divided by the square of greater than 27 with other serious rization. Additionally, access to appeared willing to read labels height in meters] of approximately comorbidities.44,71,72 The Aus- diet drugs is not associated with an and learn about side effects and 27) adults aged 18 years and tralia pharmacist professional so- immediate need, so BTC phar- dosage requirements.77 older.62 These usage conditions ciety recommends pharmacists macy status would not unneces- Despite the necessity of and instructions are disclosed on consider a customer's BMI, waist sarily impede access for a medi- strengthening the warning labels the product label, including circumference, and age upon a re- cally approved use.
for certain OTC products abused a weight chart for consumer refer- quest for orlistat.73 The literature does not reveal for weight control, risks can ence. Since its approval, the FDA how the pharmacy recommenda- sometimes be best reduced by has required increased warnings tions to verify BMI in the United requiring a health care profes- related to possible organ damage.63 REGULATIONS FOR ALLI Kingdom, Ireland, and Australia sional to educate consumers or Although alli is approved for have been carried out in practice determine proper dispensation overweight adults only, the FDA Unlike for OTC laxatives, in- or how they are enforced. There is criteria.77 In the context of the does not enforce this requirement, structions and approved condi- a concern of stigmatizing over- products analyzed, BTC place- and alli can be purchased in retail tions for use are stated on alli's weight people if pharmacists are ment may be warranted to en- establishments, pharmacies, and packaging. The label speciﬁcally required to weigh consumers or courage pharmacist consultation online without age or weight ver- indicates that the product is for otherwise verify BMI. This could or allow for age veriﬁcation.
iﬁcation. The manufacturer re- adults 18 years old or older and inadvertently result in people who Restricting direct-consumer ac- portedly has requested that retail that one should not take the would beneﬁt from the weight loss cess to products that have poten- partners examine the customer's product if one is not overweight drug not requesting the product to tial public health ramiﬁcations age at time of purchase (L. M. T., or take more than the recommen- avoid such a measure.
is a common feature of the US telephone interview with Fran ded dose.62 If studies continue regulatory environment, such as Cilella, Customer Sales Manager, to reveal that alli is a product of the case of prescription drugs, GlaxoSmithKline; 2010); how- abuse, increased warnings may be RECOMMENDED ACTIONS tobacco, and alcohol.55 Restrict- ever, not all retailers follow this warranted to educate consumers ing access in the alcohol context, practice,64 and online Web sites so they can make informed The FDA has determined that for example, aims to protect do not check the age of online the disclosure of usage and safety youths from the potentially neg- customers.65,66 Furthermore, re- In terms of regulating access, information on OTC drug pack- ative consequences of engaging tailers are not requested to de- alli is the only FDA-approved OTC aging is important to allow con- in a behavior for which they termine BMI prior to selling the weight loss aid. However, it has sumers to protect themselves and may not be developmentally product to consumers.
many indications for use that are their families.74 Research into prepared, and has been found to Regulations are diverse inter- not enforced in the United States, the effects of warning labels ap- successfully reduce youth con- nationally. In 2009, the European including age, dosing, and BMI pears in the marketing, policy, and sumption.78 A similar rationale is e4 Analytic Essays Peer Reviewed Pomeranz et al.
American Journal of Public Health Published online ahead of print December 13, 2012 SCIENTIFIC EVIDENCE, SOCIAL RESPONSIBILITY, AND GOVERNMENTAL INTERVENTION relevant for products that have Edwards Street, Box 208369, New Haven, Neumark-Sztainer D, Croll J, Story eating disorders. Int J Eat Disord. 2010; age requirements for their use CT 06520-8369 (e-mail: jennifer.
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