Economic Value of Initial Implementation Activities for Proposed Ban on Sales of Over-The-Counter Diet Pills and Muscle-Building Supplements to Minors.

Introduction: Over-the-counter diet pills, weight-loss supplements, and muscle-building supplements often contain harmful ingredients and are associated with eating disorder diagnoses and other negative health outcomes. This study estimated the value of state initial implementation activities, for example, regulation development, to implement a ban on the sale of dangerous over-the-counter diet pills and muscle-building supplements to minors. Methods: We enumerated minimum, best, and maximum values for 22 inputs among 11 activities state employees may undertake if the legislation were signed into law. For employment costs, we estimated staff hours on the basis of data from 10 key informants and obtained salary ranges from a state government website. Data were collected and analyzed between September 2021 and January 2022. We calculated 95% CIs using 10,000 Monte Carlo simulations that varied inputs simultaneously and probabilistically. We conducted two sensitivity analyses using all minimum and all maximum salaries. Results: The estimated value of state start-up activities was $47,536 (95% CI=$36,831-$57,381). Inputs with the largest impact on this estimate corresponded to combinations of the highest salary and greatest hours per task. Conclusions: The state's one-time opportunity cost to initiate this age-restriction policy would be minimal considering potential health gains. Sensitivity analyses did not change the conclusion, especially if the state produces subregulations linked to existing law rather than new regulations.

Liver Transplantation for Fulminant Hepatic Failure Precipitated by Pheochromocytoma Crisis in the Setting of Using Garcinia cambogia Weight Loss Supplement: A Case Report.

We report the first case of liver transplantation for fulminant hepatic failure precipitated by hepatocellular injury due to the synergistic effect of pheochromocytoma crisis and simultaneous use of Garcinia cambogia. Complex diagnosis and treatment decisions are discussed, as well as possible pathophysiology that led to liver failure.

Resistant Polymorphic Ventricular Tachycardia in a Patient Taking Raspberry Ketones Weight Loss Supplement.

A 32-year-old female with no cardiac risk factors was admitted for treatment of a perianal abscess. During her hospital stay, she had a pulseless electrical activity arrest with a return of spontaneous circulation after one round of cardiopulmonary resuscitation (CPR). After transfer to the Intensive Care Unit (ICU), the patient had polymorphic ventricular tachycardia (PVT) requiring defibrillation shock. Her PVT was resistant to medical interventions. She was shocked a total of 33 times before her arrhythmia was terminated by passing a temporary transvenous pacemaker with overdrive pacing. After an extensive review of her history and presentation, no clear cause of her resistant arrhythmia was identified, however, she was found to have recently started taking over-the-counter weight loss supplements containing raspberry ketones which is a potentially cardiotoxic ingredient.

Adulteration of Weight Loss Supplements by the Illegal Addition of Synthetic Pharmaceuticals.

Weight loss supplements that have illegal additives of pharmaceutical drugs or analogues have additional health risks, and customers may not be aware of what they are taking. This research is an essential investigation and quantification of illegally added pharmaceuticals or prescription medications, specifically fluoxetine, phenolphthalein, and sibutramine, in herbal weight loss supplements offered for sale in the United Arab Emirates (UAE). In this case, 137 weight loss supplements were collected and analyzed in this study. Reversed-phase high-performance liquid chromatography with UV absorption detection coupled to tandem mass spectrometry (RP-HPLC-MS/MS) analyses were used to determine the presence of the pharmaceutical chemicals. Among the weight loss supplements, 15.3% (95% CI: 9.2-21.4) contained undeclared sibutramine, 13.9% (95% CI: 8.01-19.7) contained undeclared phenolphthalein, and 5.1% (95% CI: 1.4-8.8) contained undeclared fluoxetine. Amongst all weight loss supplements, 17.5% (95% CI: 11.07-24) contained significant concentrations of either sibutramine, phenolphthalein, or fluoxetine. Whilst weight loss herbal supplements offered for sale in the UAE have relatively low percentages of undeclared pharmaceuticals, many people take several different supplements daily and may encounter quite high levels of combined exposure to toxic compounds.

Body Building and Aminotransferase Elevations: A Review.

In addition to liver injury, elevation of aminotransferases can be caused by strenuous exercise and use of muscle-building and weight-loss supplements. The purpose of this review is to discuss the various mechanisms of elevation of aminotransferases related to body building. A literature review was performed on clinical trials and case reports involving exercise or supplement use and their effects on aminotransferases. Normal aminotransferase levels varied according to gender, age, body mass index, and comorbidities. Strenuous exercise and weight lifting, especially in the unaccustomed, can cause elevated aminotransferases in the absence of liver damage. Supplements such as anabolic steroids, ephedra, and LipoKinetix, amongst others, have also been associated with aminotransferase elevations. The pattern of elevation of aminotransferases is not helpful in distinguishing liver from muscle injury. Other associated muscle enzymes can be useful in making that distinction. To prevent aminotransferase elevations, subjects not accustomed to moderate-high intensity workouts, are recommended to undertake gradual increase in intensity. When causes of liver injury have been ruled out, investigation into bodybuilding, extreme exercise, and supplement use is warranted.

The stimulant higenamine in weight loss and sports supplements.

BACKGROUND: Higenamine is a stimulant with cardiovascular properties recently prohibited in sport by the World Anti-Doping Agency (WADA). Higenamine is also a natural constituent of several traditional botanical remedies and is listed as an ingredient in weight loss and sports supplements sold over-the-counter in the United States. OBJECTIVES: We analyzed dietary supplements available for sale in the United States prior to WADA's prohibition of higenamine in sport for the presence and quantity of higenamine. METHODS: All supplements labeled as containing higenamine or a synonym (i.e., norcoclaurine or demethylcoclaurine) available for sale in the United States were identified. For each brand, one sample was analyzed by NSF International (Ann Arbor, MI) and one sample by the Netherland's National Institute for Public Health and the Environment (RIVM). NSF International carried out qualitative and quantitative analyses using ultra high performance liquid chromatography (UHPLC) with tandem mass spectrometry. RIVM carried out qualitative analysis using UHPLC quadrupole time of flight mass spectrometry for an independent confirmation of identity. RESULTS: Twenty-four products were analyzed. The majority of supplements were marketed as either weight loss (11/24; 46%) or sports/energy supplements (11/24; 46%); two brands did not list a labeled indication. The quantity of higenamine (±95% CI) ranged from trace amounts to 62 ± 6.0 mg per serving. Consumers could be exposed to up to 110 ± 11 mg of higenamine per day when following recommended serving sizes provided on the label. Five products (5/24; 21%) listed an amount of higenamine, but none were accurately labeled; the quantity in these supplements ranged from <0.01% to 200% of the quantity listed on the label. CONCLUSION: Dosages of up to 62 ± 6.0 mg per serving of the stimulant higenamine were found in dietary supplements sold in the United States.

Acute liver injury following Garcinia cambogia weight-loss supplementation: case series and literature review.

Herbal weight-loss supplements are sold as self-medication products, and are often used under the misconception that their natural origin guarantees their safety. Food supplements are not required to provide any benefit/risk profile evaluation before marketing; however, possible risks associated with use of herbal extracts in food supplements are becoming more and more documented in the literature. Some herbs are listed as the leading cause of herb-induced liver injury, with a severe or potentially lethal clinical course, and unpredictable herb-drug interactions. Garcinia cambogia (GC) extract and GC-containing products are some of the most popular dietary supplements currently marketed for weight loss. Here, we present four cases of acute liver failure in women taking GC extract for weight loss, and a literature review of clinical evidences about hepatic toxicity in patients taking dietary supplements containing GC extract.

Application of HRAM screening and LC-MS/MS confirmation of active pharmaceutical ingredient in "natural" herbal supplements.

The growing market of herbal remedies worldwide could pose severe problems to consumers' health due to the possible presence of potentially harmful, undeclared synthetic substances or analogues of prescription drugs. The present work shows a simple but effective approach to unequivocally identify synthetic anorectic compounds in allegedly 'natural' herbal extracts, by exploiting liquid chromatography/time of flight (Q-TOF LC/MS) technology coupled to liquid chromatography/triple quadrupole (LC-MS/MS) confirmation and quantitation. The procedure was applied to five tea herbal extracts and pills sold as coadjutant for weigh loss. The method exploited liquid-liquid sample extraction (LLE) and separation in a C18 (2.1mm×150mm, 1.8µm) column. QTOF acquisitions were carried out both in scan mode and all ion MS/MS mode and results were obtained after search against ad hoc prepared library. Sibutramine, 4-hydroxyamphetamine, caffeine and theophylline were preliminary identified samples. Confirmation and quantitation of the preliminary identified compounds were obtained in LC-MS/MS after preparation of appropriated standards. Sibutramine, caffeine and theophylline were finally confirmed and quantitate.

1,5-Dimethylhexylamine (octodrine) in sports and weight loss supplements: Natural constituent or synthetic chemical?

In the past years, there has been a mounting trend toward the addition of sympathomimetic stimulants in sports and weight loss supplements sold in the US and claimed to be from natural constituents. The latest among those pharmaceutical stimulants is 1,5-dimethylhexylamine (1,5-DMHA or octodrine), an ingredient in newly introduced sports and weight loss supplements with its 'natural' origin being cited from Aconitum or Kigelia plants. In order to validate the natural existence of 1,5-DMHA, two GC/MS methods were developed. One method involved using thick film megabore capillary columns to analyze the underivatized 1,5-DMHA. The second method was to determine enantiomeric distribution of 1,5-DMHA. Fifteen Aconitum or Kigelia plant samples originating from various locations were analyzed, and none of them contained 1,5-DMHA within the limit of detection (25 ng/mL) of the method. In contrast, although 1,5-DMHA was listed on the labels or website for all the 13 dietary supplements, only four products were found to contain this compound, with the highest quantity being reported as 112 mg per serving size. This is equivalent to more than three times the highest pharmaceutical dose established in Europe. The enantiomeric ratios of 1,5-DMHA in these products were determined to be between 0.9-1.0 (expressed as peak area ratio of one enantiomer over another), suggesting racemic nature. Interestingly, two byproducts from 1,5-DMHA synthesis were identified in commercial supplements containing 1,5-DMHA, indicating that 1,5-DMHA indeed originated from a poor quality source. Overall, the significant amount of 1,5-DMHA observed in the supplements, the enantiomeric distribution and the presence of the synthetic byproducts all suggested the synthetic origin of 1,5-DMHA in the commercial products.

Four experimental stimulants found in sports and weight loss supplements: 2-amino-6-methylheptane (octodrine), 1,4-dimethylamylamine (1,4-DMAA), 1,3-dimethylamylamine (1,3-DMAA) and 1,3-dimethylbutylamine (1,3-DMBA).

BACKGROUND: The United States Food and Drug Administration banned the stimulant 1,3-dimethylamylamine (1,3-DMAA) from dietary supplements and warned consumers that the stimulant can pose cardiovascular risks ranging from high blood pressure to heart attacks. OBJECTIVES: We designed our study to determine if a new stimulant similar in structure to 1,3-DMAA has been introduced as an ingredient in supplements sold in the United States (US). METHODS: We analyzed six brands of supplements that listed an ingredient on the label (e.g., Aconitum kusnezoffii, DMHA or 2-amino-isoheptane) that might refer to an analog of 1,3-DMAA. Supplements were analyzed by two separate laboratories using ultra-high-performance liquid chromatography mass spectrometry and reference standards. RESULTS: Two previously unidentified 1,3-DMAA analogs (2-amino-6-methylheptane [octodrine] and 1,4-dimethylamylamine [1,4-DMAA]) and two banned stimulants (1,3-DMAA and 1,3-dimethylbutylamine [1,3-DMBA]) were identified. Octodrine was found at a dose (±95% CI) of 72 ± 7.5 mg per serving. In Europe, octodrine was previously sold as a pharmaceutical in multi-ingredient medications at dosages from 8 to 33 mg. The quantity of octodrine found in our study was more than twice the largest pharmaceutical dose. The other new stimulant, 1,4-DMAA, has not previously been approved for human consumption, and its safety in humans is unknown. 1,4-DMAA was found at dosages between 21 ± 11 mg to 94 ± 48 mg per serving. In addition, two banned stimulants - 1,3-DMAA and 1,3-DMBA - were also identified: 24 ± 7.6 mg to 35 ± 11 mg of 1,3-DMAA and 51 ± 16 mg of 1,3-DMBA. In one product, 24 ± 7.6 mg of 1,3-DMAA was combined with 21 ± 11 mg of 1,4-DMAA. 1,3-DMAA has been investigated as potentially contributing to hemorrhagic strokes and sudden death, whereas the safety of 1,3-DMBA in humans is unknown. CONCLUSION: Two banned stimulants (1,3-DMAA and 1,3-DMBA) and two previously unidentified stimulants (1,4-DMAA and octodrine) were identified in supplements sold in the United States.

Dangerous dietary supplements: Garcinia cambogia-associated hepatic failure requiring transplantation.

Commercial dietary supplements are marketed as a panacea for the morbidly obese seeking sustainable weight-loss. Unfortunately, many claims cited by supplements are unsupported and inadequately regulated. Most concerning, however, are the associated harmful side effects, often unrecognized by consumers. Garcinia cambogia extract and Garcinia cambogia containing products are some of the most popular dietary supplements currently marketed for weight loss. Here, we report the first known case of fulminant hepatic failure associated with this dietary supplement. One active ingredient in this supplement is hydroxycitric acid, an active ingredient also found in weight-loss supplements banned by the Food and Drug Administration in 2009 for hepatotoxicity. Heightened awareness of the dangers of dietary supplements such as Garcinia cambogia is imperative to prevent hepatoxicity and potential fulminant hepatic failure in additional patients.

Liver Injury from Herbal, Dietary, and Weight Loss Supplements: a Review.

Herbal and dietary supplement usage has increased steadily over the past several years in the United States. Among the non-bodybuilding herbal and dietary supplements, weight loss supplements were among the most common type of HDS implicated in liver injury. While drug induced liver injury is rare, its consequences are significant and on the rise. The purpose of this review is to highlight case reports of weight loss products such as Hydroxycut and OxyElite Pro as one form of HDS that have hepatotoxic potential and to characterize its clinical effects as well as pattern of liver injury. We also propose future strategies in the identification and study of potentially hepatotoxic compounds in an effort to outline a diagnostic approach for identifying any drug induced liver injury.

The liberating effect of weight loss supplements on dietary control: a field experiment.

OBJECTIVES: Taking weight-loss supplements may create illusion of protection against weight gain and thereby loosen subsequent dietary self-control. The current study examined whether taking weight-loss supplement would increase food intake and further tested whether positive attitudes toward supplements would increase susceptibility to overeating. METHODS: Participants were randomly assigned to take either a known placebo or a purported weight loss supplement (actually, the same placebo). After supplement provision, participants' actual food consumption at a reward buffet lunch was recorded. RESULTS: Compared with controls, participants receiving a purported weight loss supplement ate more food at the reward buffet. Perceived progress toward the goal of weight reduction mediated the connection between use of weight loss supplements and subsequent food consumption. Participants with more positive attitudes toward weight loss supplements were more susceptible to the liberating effect of taking weight loss supplements on food intake. CONCLUSION: Using weight loss supplements may produce unintended consequences on dietary self-regulation. The public should pay more attention to the notion of psychological liberation when using weight loss supplements.

Taking weight-loss supplements may elicit liberation from dietary control. A laboratory experiment.

Given that changes in diet and exercise habits are difficult to initiate and maintain, the use of weight-loss supplements has become an appealing alternative approach to weight management for many individuals. The current research examined whether the use of weight-loss supplements induced overly optimistic assessments of progress toward weight reduction, leading to psychological abdication of dietary regulation. Participants were randomly assigned to take either an identified placebo or a purported weight-loss supplement (actually the same placebo). Each participant reported perceived progress toward weight reduction following the manipulation. Consumption of snacks in a taste test and choice of sugary drinks were recorded. The results showed that participants receiving a purported supplement ate more in a taste task and preferred larger quantities of sugar in their reward drinks than did controls. Mediation analysis supported that the perception of progress toward weight reduction contributed to the liberating effect. Using weight-loss supplements may increase perceived progress toward weight reduction but decrease dietary self-regulation. These thought-provoking findings can serve as a basis for educating the public about the myth that they are free to feel liberated from the need to regulate their eating when using weight-loss supplements.