0
We're unable to sign you in at this time. Please try again in a few minutes.
Retry
We were able to sign you in, but your subscription(s) could not be found. Please try again in a few minutes.
Retry
There may be a problem with your account. Please contact the AMA Service Center to resolve this issue.
Contact the AMA Service Center:
Telephone: 1 (800) 262-2350 or 1 (312) 670-7827  *   Email: subscriptions@jamanetwork.com
Error Message ......
Viewpoint |

Dietary Supplementation in Children and Adolescents:  Supplementing With the “Correct” Amount

Michael M. Madden, PhD1; G. Elliott Cook, PharmD, BCPS2
[+] Author Affiliations
1Lake Erie College of Osteopathic Medicine School of Pharmacy, Erie, Pennsylvania
2Provider Resources, Inc, Erie, Pennsylvania
JAMA Pediatr. 2013;167(11):991-992. doi:10.1001/jamapediatrics.2013.2908.
Text Size: A A A
Published online

Extract

The drug approval process of the US Food and Drug Administration (FDA) has evolved into the world’s gold standard for ensuring that drugs introduced to the public are safe and effective for their intended use. One important and often overlooked part of the FDA’s approval process by health care professionals is that of manufacturing. The FDA ensures, through premarket approval standards, that drugs contain the labeled amount of active pharmaceutical ingredient, even if the product is generic. Unfortunately, the same cannot be said about products that do not undergo premarket review, such as dietary supplements. Dietary supplements are regulated separately from drugs under the regulatory framework created by the Dietary Supplement Health and Education Act of 1994. The Dietary Supplement Health and Education Act of 1994 allows dietary supplements to forgo premarket review by the FDA, instead initially relying on dietary supplement manufacturers’ compliance with FDA regulation and guidance. Given the lack of premarket review, dietary supplement manufacturers should follow dietary supplement current good manufacturing practices (cGMPs), as required. Through cGMP, the FDA can ensure the identity, strength, quality, and purity of dietary supplements through adequate regulation of manufacturing operations and processes. Compliance with cGMP could ultimately attenuate concern about the differences between dietary supplement labeling and container content. Unfortunately, dietary supplements have been riddled with cGMP noncompliance. Problems found in cGMP inspections of dietary supplement manufacturers are reported in a majority of inspections, lending little credence to the notion of safety and compliance without premarket review.1 Health care providers and the public may expect the label of dietary supplements to reflect the contents of the container, but a recent study by LeBlanc et al2 has defied those expectations and points to a potential serious public health concern.

Topics

diet

Sign in

Create a free personal account to sign up for alerts, share articles, and more.

Purchase Options

• Buy this article
• Subscribe to the journal

First Page Preview

View Large
First page PDF preview

Figures

Tables

References

Correspondence

CME
Meets CME requirements for:
Browse CME for all U.S. States
Accreditation Information
The American Medical Association is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The AMA designates this journal-based CME activity for a maximum of 1 AMA PRA Category 1 CreditTM per course. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Physicians who complete the CME course and score at least 80% correct on the quiz are eligible for AMA PRA Category 1 CreditTM.
Note: You must get at least of the answers correct to pass this quiz.
You have not filled in all the answers to complete this quiz
The following questions were not answered:
Sorry, you have unsuccessfully completed this CME quiz with a score of
The following questions were not answered correctly:
Commitment to Change (optional):
Indicate what change(s) you will implement in your practice, if any, based on this CME course.
Your quiz results:
The filled radio buttons indicate your responses. The preferred responses are highlighted
For CME Course: A Proposed Model for Initial Assessment and Management of Acute Heart Failure Syndromes
Indicate what changes(s) you will implement in your practice, if any, based on this CME course.
Submit a Comment

Multimedia

Some tools below are only available to our subscribers or users with an online account.

Web of Science® Times Cited: 1

Sign in

Create a free personal account to sign up for alerts, share articles, and more.

Purchase Options

• Buy this article
• Subscribe to the journal

Related Content

Customize your page view by dragging & repositioning the boxes below.

Articles Related By Topic
Related Collections
PubMed Articles
Jobs
brightcove.createExperiences();