The role of good manufacturing practices for preventing dietary supplement adulteration

Whitsitt, Victoria; Beehner, Cindy; Welch, Cara

doi:10.1007/s00216-012-6663-6

Cited by 11 publications

(9 citation statements)

References 2 publications

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“…3). Such a three-layer approach is also in agreement with fundamental QC steps specified under identity, composition/strength, and purity, in U.S. cGMPs for dietary supplements [8,22,31].…”

Section: Exploring the Meaning Of Authenticity And Its Relation Tomentioning

confidence: 69%

“…World Health Organization (WHO) guidelines for QC of herbal materials defines adulterated material as “ herbal material, an herbal constituent or other substance that is either deliberately or non-intentionally (through cross-contamination or contamination) added to an herbal material, herbal preparation, or finished herbal product ” [1]. Another definition is: “ to make impure by adding foreign, extraneous, poisonous, insanitary, or inferior substances/ingredients to a (food) product ” [22]. Adulteration is also described in great detail under title 21 (covering food and drugs) of the U.S. code of Federal Regulations [23].…”

Section: Exploring the Meaning Of Authenticity And Its Relation Tomentioning

confidence: 99%

“…The so-called EMA (Economically Motivated Adulteration) is defined by the USP in the context of food fraud as: “ the fraudulent addition of non-authentic substances or removal or replacement of authentic substances without the purchaser’s knowledge for economic gain of the seller ” [27,30]. Under U.S. statutes, botanicals are deemed adulterated and subject to law enforcement if they have been manufactured, packaged, and/or distributed without compliance to the current Good Manufacturing Practices (cGMPs) [8,22,23], or, in the case of a commercially-available packaged botanical or herbal product, if they are found to contain an ingredient not indicated on the product label [23,27,31].…”

Section: Exploring the Meaning Of Authenticity And Its Relation Tomentioning

confidence: 99%

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Integrated analytical assets aid botanical authenticity and adulteration management

Simmler

Graham²,

Chen

et al. 2018

Fitoterapia

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This article reviews and develops a perspective for the meaning of authenticity in the context of quality assessment of botanical materials and the challenges associated with discerning adulterations vs. contaminations vs. impurities. Authentic botanicals are by definition non-adulterated, a mutually exclusive relationship that is confirmed through the application of a multilayered set of analytical methods designed to validate the (chemo)taxonomic identity of a botanical and certify that it is devoid of any adulteration. In practice, the ever-increasing sophistication in the process of intentional adulteration, as well as the growing number of botanicals entering the market, altogether necessitate a constant adaptation and reinforcement of authentication methods with new approaches, especially new technologies. This article summarizes the set of analytical methods - classical and contemporary - that can be employed in the authentication of botanicals. Particular emphasis is placed on the application of untargeted metabolomics and chemometrics. An NMR-based untargeted metabolomic model is proposed as a rapid, systematic, and complementary screening for the discrimination of authentic vs. potentially adulterated botanicals. Such analytical model can help advance the evaluation of botanical integrity in natural product research.

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“…3). Such a three-layer approach is also in agreement with fundamental QC steps specified under identity, composition/strength, and purity, in U.S. cGMPs for dietary supplements [8,22,31].…”

Section: Exploring the Meaning Of Authenticity And Its Relation Tomentioning

confidence: 69%

Section: Exploring the Meaning Of Authenticity And Its Relation Tomentioning

confidence: 99%

Section: Exploring the Meaning Of Authenticity And Its Relation Tomentioning

confidence: 99%

See 1 more Smart Citation

Integrated analytical assets aid botanical authenticity and adulteration management

Simmler

Graham²,

Chen

et al. 2018

Fitoterapia

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“…Implementing U.S. Food and Drug Administration good manufacturing practices for dietary supplements can mitigate risk of contamination and poor quality control. 158 Incorporating emerging findings from clinical and neurobiological 159 research of contextual and placebo effects can enhance the delivery 160 and understanding of some CAM approaches. Overall, the application of preventive medicine principles and recent quality improvement initiatives can strengthen integrative medicine in the context of a healthcare system moving to value-based care.…”

Section: Discussionmentioning

confidence: 99%

Disease Prevention and Health Promotion

Ali

Katz

2015

American Journal of Preventive Medicine

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As a discipline, preventive medicine has traditionally been described to encompass primary, secondary, and tertiary prevention. The fields of preventive medicine and public health share the objectives of promoting general health, preventing disease, and applying epidemiologic techniques to these goals. This paper discusses a conceptual approach between the overlap and potential synergies of integrative medicine principles and practices with preventive medicine in the context of these levels of prevention, acknowledging the relative deficiency of research on the effectiveness of practice-based integrative care. One goal of integrative medicine is to make the widest array of appropriate options available to patients, ultimately blurring the boundaries between conventional and complementary medicine. Both disciplines should be subject to rigorous scientific inquiry so that interventions that are efficacious and effective are systematically distinguished from those that are not. Furthermore, principles of preventive medicine can be infused into prevalent practices in complementary and integrative medicine, promoting public health in the context of more-responsible practices. The case is made that an integrative preventive approach involves the responsible use of science with responsiveness to the needs of patients that persist when conclusive data are exhausted, providing a framework to make clinical decisions among integrative therapies.

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“…5 It is nevertheless possible that a sympathomimetic component of some type, potentially as an adulterant or a previously unreported effect of the listed ingredients, could lead to the development of ventricular arrhythmias. 6 We report a case of ventricular tachycardia related to Hydroxycut Gummies (Muscle Tech).…”

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confidence: 99%

Ventricular Tachycardia Precipitated by the Use of the Diet Supplement Hydroxycut Gummies

et al. 2015

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Background: Dietary supplements have a long history of causing adverse effects. Ventricular arrhythmias have not been described with Hydroxycut Gummies. Objective: To report a case of ventricular arrhythmia after prolonged use of a popular dietary supplement, Hydroxycut Gummies. Case Report: An 18-year-old female with no significant past medical history presented with lifethreatening ventricular arrhythmia following about 10 days of use of Hydroxycut Gummies, a legal dietary supplement previously unreported to cause this complication. The patient received external cardioversion due to progressive decline in mental status and persistent hypotension and was initiated on intravenous procainamide at an outside hospital. Left ventricular ejection fraction was 45% to 50%, and cardiac MRI showed no definite finding of infarct, myocarditis, or fibrosis. Beta-blocker therapy was initiated, and there was a progressive reduction in ventricular arrhythmia burden with an improvement of symptoms over the next few days. Two and a half months after the initial hospitalization, follow-up Holter monitor revealed occasional accelerated idioventricular rhythm events and a significant reduction in, but still occasional, long monomorphic ventricular tachycardia events. None of the ingredients listed in this product have been associated with cardiac dysrhythmias in the literature. One phytochemical potentially in the product is alpha-quinidine, which could be the cause of the adverse event. However, there was no other identifiable etiology for the ventricular tachycardia, which resolved after the discontinuation of supplement and the addition of beta-blocker therapy. Conclusion: Hydroxycut Gummies should be considered a probable cause of this patient's arrhythmia given the lack of another etiology and a Naranjo Scale score of 6.

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The role of good manufacturing practices for preventing dietary supplement adulteration

Cited by 11 publications

References 2 publications

Integrated analytical assets aid botanical authenticity and adulteration management

Integrated analytical assets aid botanical authenticity and adulteration management

Disease Prevention and Health Promotion

Ventricular Tachycardia Precipitated by the Use of the Diet Supplement Hydroxycut Gummies

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