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.
Thank you for submitting a comment on this article. It will be reviewed by JAMA Pediatrics editors. You will be notified when your comment has been published. Comments should not exceed 500 words of text and 10 references.
Do not submit personal medical questions or information that could identify a specific patient, questions about a particular case, or general inquiries to an author. Only content that has not been published, posted, or submitted elsewhere should be submitted. By submitting this Comment, you and any coauthors transfer copyright to the journal if your Comment is posted.
* = Required Field
Disclosure of Any Conflicts of Interest*
Indicate all relevant conflicts of interest of each author below, including all relevant financial interests, activities, and relationships within the past 3 years including, but not limited to, employment, affiliation, grants or funding, consultancies, honoraria or payment, speakers’ bureaus, stock ownership or options, expert testimony, royalties, donation of medical equipment, or patents planned, pending, or issued. If all authors have none, check "No potential conflicts or relevant financial interests" in the box below. Please also indicate any funding received in support of this work. The information will be posted with your response.
Some tools below are only available to our subscribers or users with an online account.
Download citation file:
Web of Science® Times Cited: 1
Customize your page view by dragging & repositioning the boxes below.
More Listings atJAMACareerCenter.com >
The Rational Clinical Examination: Evidence-Based Clinical Diagnosis
Original Article: Is This Adult Patient Malnourished?
All results at
Enter your username and email address. We'll send you a link to reset your password.
Enter your username and email address. We'll send instructions on how to reset your password to the email address we have on record.
Athens and Shibboleth are access management services that provide single sign-on to protected resources. They replace the multiple user names and passwords necessary to access subscription-based content with a single user name and password that can be entered once per session. It operates independently of a user's location or IP address. If your institution uses Athens or Shibboleth authentication, please contact your site administrator to receive your user name and password.