United States: GNC Lawsuit Reflects FDA's Crackdown On Dietary Supplement Industry

The Oregon Attorney General's Office hit General Nutrition Centers (GNC) with a lawsuit last week alleging that the company knowingly sold supplements that contained FDA-banned ingredients. The action should serve as a cautionary tale to the dietary supplement industry facing renewed FDA scrutiny. Although denied by GNC, the accusations and allegations continue as evidenced by the complaint filed by the Oregon State Attorney General and recent FDA Warning Letters, including several issued six months prior that specifically addressed one of the suspect ingredients in Oregon.

The impact on the industry is yet to be fully known, however, the dietary supplement industry can be assured that if nothing else, there is a heightened awareness of its activities by both public and government entities. In light of these recent events, supplement manufactures should conduct a careful internal review of ingredients, labels and new dietary ingredient filings.

FDA Warning Letters and the GNC Lawsuit

In April 2015, the FDA issued a series of warning letters to dietary supplement manufacturers and sellers in regards to the inclusion of an unapproved ingredient, Beta-methylphenethylamine, also known as βMePEA, or BMPEA. Some of these companies listed BMPEA as an ingredient on their product's ingredient listings, while others hid the product behind claims that BMPEA is an extract of the Acacia rigidula plant. These FDA warning letters asserted that BMPEA is not an approved dietary ingredient as defined by 21 U.S.C. § 321(ff)(1). The FDA also stated that BMPEA is not an approved food additive, not approved for use in dietary supplements, with no evidence that the substance is or should be considered Generally Recognized as Safe (GRAS). Additionally, the letter reported that FDA research found that Acacia rigidula does not contain amphetamines like BMPEA. The warning letters stated that products containing BMPEA disguised as the plant extract were all, therefore, misbranded under 21 U.S.C. § 343(a)(1).

Since these warning letters, many of these products have been taken off the market or reformulated. However, Oregon Attorney General Ellen Rosenbaum filed a lawsuit on Oct. 22, 2015 against General Nutrition Centers, or GNC, for continuing to sell BMPEA under the guise of Acacia rigidula in 22 of its workout and fat-burning supplement products. The 30-page complaint goes into significant detail regarding the nature of BMPEA and claims that GNC violated the Oregon Unlawful Trade Practices Act (UTPA) by:

"misrepresenting that various products that GNC sold in Oregon were lawful dietary supplements when in fact those products were adulterated and unlawful because they contained either picamilon or BMPEA, dangerous ingredients that do not meet the legal definition of a dietary ingredient and may not be lawfully used in dietary supplements."

The two cited ingredients, picamilon and BMPEA, are not approved dietary ingredients or food additives by the FDA. In fact, BMPEA, according to Rosenbaum's lawsuit, is a synthetic chemical similar to amphetamine and banned by the World Anti-Doping Organization.

Finally, the lawsuit provides several email transcripts claiming to show that not only were GNC representatives aware that picamion and BMPEA were unapproved components of their products, but may also show that GNC continued to sell products containing picamilon and BMPEA after being warned by the Oregon AG office in June.

New Dietary Ingredients and Substances for Use in Dietary Supplements

Under 21 C.F.R. § 321(ff)(1), a dietary ingredient is defined as a vitamin; mineral; herb or other botanical; amino acid; dietary substance for use by man to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of the preceding substances. In order to use a new dietary ingredient in a dietary supplement, the FDA requires that companies notify the FDA prior to selling the supplement containing it, and be able to provide to the FDA scientific evidence supporting the use of the dietary ingredient in the supplement.

However, in order to be approved for use in a supplement, a new dietary ingredient must actually be a dietary ingredient. The problem with the picamilon and BMPEA allegedly found in GNC's products is that the FDA has explicitly found that they are not dietary ingredients, as neither fits the description of any of the items in §321(ff)(1), as defined above. As a result, the FDA found in its warning letters that including either in a supplement's list of dietary ingredients renders the supplement misbranded, as it would then contain misleading or untruthful statements.

The only other way a non-food ingredient (food ingredients are defined as those substances normally eaten as foods on their own by humans, and are not subject to dietary ingredient requirements or GRAS certification) can be included in a human dietary supplement is if it has been found to be GRAS, either by the FDA, on its own or as a result of an industry petition. It is important to note that in its warning letters, the FDA issued an invitation to the warned companies to provide supporting evidence by which the FDA could find picamilon or BMPEA to be GRAS. To date, no such findings have been published by the FDA. Since neither picamilon nor BMPEA are recognized as GRAS products by the FDA, and are not the subject of a new dietary ingredient notice to the FDA, they currently cannot be used in human dietary supplements.

This Oregon suit is simply the next step in an ongoing nationwide investigation into the dietary supplement industry, which began in earnest with the FDA's announcement on Nov. 18, 2013 of its testing of 21 dietary supplements that were labeled as "all natural." The FDA found that nine of those tested to contained BMPEA and others had unapproved, synthetic substances not tested for safety in humans. The FDA subsequently seized $2 million in supplements from one manufacturer alone as a result of the Agency's testing and investigation.

These FDA enforcement actions and investigations continued with several new warning letters to dietary supplement companies issued in April 2015 for selling products containing unapproved ingredients. Again, the FDA found that by including these unapproved substances, the supplements that contained them were rendered misbranded or adulterated. The dietary supplement industry, through these FDA enforcement actions, is on notice that its products are under increased national scrutiny, and an internal review of ingredients, labels, and new dietary ingredient filings is well-warranted.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

In association with
Related Video
Up-coming Events Search
Font Size:
Mondaq on Twitter
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
Email Address
Company Name
Confirm Password
Mondaq Topics -- Select your Interests
 Law Performance
 Law Practice
 Media & IT
 Real Estate
 Wealth Mgt
Asia Pacific
European Union
Latin America
Middle East
United States
Worldwide Updates
Check to state you have read and
agree to our Terms and Conditions

Terms & Conditions and Privacy Statement

Mondaq.com (the Website) is owned and managed by Mondaq Ltd and as a user you are granted a non-exclusive, revocable license to access the Website under its terms and conditions of use. Your use of the Website constitutes your agreement to the following terms and conditions of use. Mondaq Ltd may terminate your use of the Website if you are in breach of these terms and conditions or if Mondaq Ltd decides to terminate your license of use for whatever reason.

Use of www.mondaq.com

You may use the Website but are required to register as a user if you wish to read the full text of the content and articles available (the Content). You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these terms & conditions or with the prior written consent of Mondaq Ltd. You may not use electronic or other means to extract details or information about Mondaq.com’s content, users or contributors in order to offer them any services or products which compete directly or indirectly with Mondaq Ltd’s services and products.


Mondaq Ltd and/or its respective suppliers make no representations about the suitability of the information contained in the documents and related graphics published on this server for any purpose. All such documents and related graphics are provided "as is" without warranty of any kind. Mondaq Ltd and/or its respective suppliers hereby disclaim all warranties and conditions with regard to this information, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Mondaq Ltd and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use or performance of information available from this server.

The documents and related graphics published on this server could include technical inaccuracies or typographical errors. Changes are periodically added to the information herein. Mondaq Ltd and/or its respective suppliers may make improvements and/or changes in the product(s) and/or the program(s) described herein at any time.


Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:

  • To allow you to personalize the Mondaq websites you are visiting.
  • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our information providers who provide information free for your use.

Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.

If you do not want us to provide your name and email address you may opt out by clicking here .

If you do not wish to receive any future announcements of products and services offered by Mondaq by clicking here .

Information Collection and Use

We require site users to register with Mondaq (and its affiliate sites) to view the free information on the site. We also collect information from our users at several different points on the websites: this is so that we can customise the sites according to individual usage, provide 'session-aware' functionality, and ensure that content is acquired and developed appropriately. This gives us an overall picture of our user profiles, which in turn shows to our Editorial Contributors the type of person they are reaching by posting articles on Mondaq (and its affiliate sites) – meaning more free content for registered users.

We are only able to provide the material on the Mondaq (and its affiliate sites) site free to site visitors because we can pass on information about the pages that users are viewing and the personal information users provide to us (e.g. email addresses) to reputable contributing firms such as law firms who author those pages. We do not sell or rent information to anyone else other than the authors of those pages, who may change from time to time. Should you wish us not to disclose your details to any of these parties, please tick the box above or tick the box marked "Opt out of Registration Information Disclosure" on the Your Profile page. We and our author organisations may only contact you via email or other means if you allow us to do so. Users can opt out of contact when they register on the site, or send an email to unsubscribe@mondaq.com with “no disclosure” in the subject heading

Mondaq News Alerts

In order to receive Mondaq News Alerts, users have to complete a separate registration form. This is a personalised service where users choose regions and topics of interest and we send it only to those users who have requested it. Users can stop receiving these Alerts by going to the Mondaq News Alerts page and deselecting all interest areas. In the same way users can amend their personal preferences to add or remove subject areas.


A cookie is a small text file written to a user’s hard drive that contains an identifying user number. The cookies do not contain any personal information about users. We use the cookie so users do not have to log in every time they use the service and the cookie will automatically expire if you do not visit the Mondaq website (or its affiliate sites) for 12 months. We also use the cookie to personalise a user's experience of the site (for example to show information specific to a user's region). As the Mondaq sites are fully personalised and cookies are essential to its core technology the site will function unpredictably with browsers that do not support cookies - or where cookies are disabled (in these circumstances we advise you to attempt to locate the information you require elsewhere on the web). However if you are concerned about the presence of a Mondaq cookie on your machine you can also choose to expire the cookie immediately (remove it) by selecting the 'Log Off' menu option as the last thing you do when you use the site.

Some of our business partners may use cookies on our site (for example, advertisers). However, we have no access to or control over these cookies and we are not aware of any at present that do so.

Log Files

We use IP addresses to analyse trends, administer the site, track movement, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information.


This web site contains links to other sites. Please be aware that Mondaq (or its affiliate sites) are not responsible for the privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of these third party sites. This privacy statement applies solely to information collected by this Web site.

Surveys & Contests

From time-to-time our site requests information from users via surveys or contests. Participation in these surveys or contests is completely voluntary and the user therefore has a choice whether or not to disclose any information requested. Information requested may include contact information (such as name and delivery address), and demographic information (such as postcode, age level). Contact information will be used to notify the winners and award prizes. Survey information will be used for purposes of monitoring or improving the functionality of the site.


If a user elects to use our referral service for informing a friend about our site, we ask them for the friend’s name and email address. Mondaq stores this information and may contact the friend to invite them to register with Mondaq, but they will not be contacted more than once. The friend may contact Mondaq to request the removal of this information from our database.


This website takes every reasonable precaution to protect our users’ information. When users submit sensitive information via the website, your information is protected using firewalls and other security technology. If you have any questions about the security at our website, you can send an email to webmaster@mondaq.com.

Correcting/Updating Personal Information

If a user’s personally identifiable information changes (such as postcode), or if a user no longer desires our service, we will endeavour to provide a way to correct, update or remove that user’s personal data provided to us. This can usually be done at the “Your Profile” page or by sending an email to EditorialAdvisor@mondaq.com.

Notification of Changes

If we decide to change our Terms & Conditions or Privacy Policy, we will post those changes on our site so our users are always aware of what information we collect, how we use it, and under what circumstances, if any, we disclose it. If at any point we decide to use personally identifiable information in a manner different from that stated at the time it was collected, we will notify users by way of an email. Users will have a choice as to whether or not we use their information in this different manner. We will use information in accordance with the privacy policy under which the information was collected.

How to contact Mondaq

You can contact us with comments or queries at enquiries@mondaq.com.

If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at problems@mondaq.com and we will use commercially reasonable efforts to determine and correct the problem promptly.