• What We Do
  • Areas of Practice
    • Dietary Supplements
    • Functional Foods
    • Sports Nutrition
  • Attorney Profiles
    • Rick Collins, Esq.
    • Alan Feldstein, Esq.
    • Michael J. DiMaggio, Esq.
    • Katie Weitzman, Esq.
  • Newsletters
  • Contact Us
  • Congratulating Brendan Barrett On His...
    Congratulating Brendan Barrett On His Recent “Ring Of Combat” Heavyweight Title Win…

    Reflections From Brendan On His Win … And What’s Next! On April 5th, in an exciting 33 second knockout, “Brutal” Brendan Barrett won the prestigious Ring of Combat Heavywei [...]

    Read more

Monthly archives for September, 2011

Attorneys of CMG to Speak about the NDI Draft Guidance at ISSN’s Europa University at the 2011 Olympia

Sep14th
2011
Leave a Comment Written by admin

This Saturday, September 17th, 2011, at the Las Vegas Convention Center Expo, Room S219, the attorneys of CMG will be speaking as part of the International Society of Sports Nutrition’s (ISSN) Europa University.

From 2:00pm-3:00pm PST – Rick Collins, Esq., FISSN, joined by Alan Feldstein, Esq. and Michael DiMaggio, Esq. will be conducting a presentation entitled: FDA Draft Guidance on New Dietary Ingredient Notifications: Is it a “Game Changer” for the Sports Nutrition Industry?

The presentation will include issues such as:

  • How FDA’s most recent guidance will affect innovation in the sports nutrition industry.
  • The Nuts and Bolts of NDI Notifications: requirements, process and exemptions.
  • What industry and consumers should know about supplement Safety Data and studies?

Please join ISSN and the attorneys of CMG this Saturday for this important presentation.

Share
Dietary Supplements, FDA, Marketing and Advertising    CMG, FDA, ISSN, NDI
SHARE THIS Twitter Facebook Delicious StumbleUpon E-mail

FDA: Comment Period for Draft Guidance Extended to December 2nd

Sep14th
2011
Leave a Comment Written by Mike DiMaggio

The industry breathed a temporary sigh of relief when they learned that FDA had extended the comment period for its New Dietary Ingredient (NDI) Draft Guidance by 60 days to Dec. 2, 2011. The extension came one month after five industry trade organizations requested FDA extend the comment period by 45 days. Jarrow Formulas, a dietary supplement manufacturer, had also sent a request to FDA for a 1 year extension of the comment period, so the 60 day extension is an apparent compromise by FDA. Dietary supplement manufacturers and distributors are encouraged to confer with their legal counsel and/or trade association to continue to develop and prepare comments for FDA.

Share
Dietary Supplements, FDA, Regulatory    Draft Guidance, extension, FDA, NDIs, new dietary ingredients
SHARE THIS Twitter Facebook Delicious StumbleUpon E-mail

GMP Compliance Still Primary Concern for Industry: NDI Notification “Not Likely” to be Enforced Through GMP Inspections

Sep1st
2011
Leave a Comment Written by Mike DiMaggio

While so many in the industry seem to be talking about NDI notifications as the biggest issue facing supplement companies, a recent poll of approximately 100 attendees at the recent United Natural Products Alliance (UNPA) seminar indicates that there’s another issue of more concern in the supplement industry today: GMP compliance. According to the survey results, reported in the August 15th “Tan Sheet” (see thumbnail image), 60% of the attendees polled said that GMP compliance is currently the most important issue facing the industry – compared to only 31% of attendees who believe that NDI notification tops the list of current concerns.

Those polled aren’t the only ones noting the importance of GMP compliance on the industry; according to Daniel Fabricant, director of FDA’s Division of Dietary Supplements, “GMPS are probably the most substantial thing industry has to work on” – noting that the FDA “is seeing a pretty high rate of noncompliance.” Fabricant went on to note that “the industry should expect more GMP enforcement” – but also disconnected the two issues by saying that the agency would “likely not” enforce NDI notification through GMP inspections.

So, for now, NDI notifications and GMPs remain two separate issues – with, it appears, more in the industry possibly less concerned about NDIs than they are about GMP compliance in today’s complex supplement industry. Therefore, as GMP compliance continues to be a growing issue, ensure that your company is following all proper practices and adhering to all current and future regulatory guidelines – and, to best meet any potential expanded GMP enforcement, consider seeking professional legal counsel to help you navigate through this important time.

Share
Dietary Supplements, Marketing and Advertising, Regulatory    dietary supplement industry, GMP, NDIs, United Natural Products Alliance
SHARE THIS Twitter Facebook Delicious StumbleUpon E-mail

Recent Posts

  • Congratulating Brendan Barrett On His Recent “Ring Of Combat” Heavyweight Title Win…
  • FDA Warns Against Dietary Supplement Ingredient DMAA
  • Rick Collins To Speak At Upcoming Sports Safety Conference
  • Debate and Legislation Surrounding Energy Drinks Ensues

Categories

  • Dietary Supplements (69)
  • FDA (56)
  • FTC (8)
  • Marketing and Advertising (23)
  • Regulatory (66)
  • Sports Nutrition (46)
  • Steroids (17)
  • Uncategorized (8)

Visit Our Websites

  • CMG Criminal Defense Blog
  • Collins, McDonald & Gann, P.C.
  • Steroid Law
  • Supplement Counsel – Main Site

Archives

Follow this blog
  • What We Do
  • Areas of Practice
    • Dietary Supplements
    • Functional Foods
    • Sports Nutrition
  • Attorney Profiles
    • Rick Collins, Esq.
    • Alan Feldstein, Esq.
    • Michael J. DiMaggio, Esq.
    • Katie Weitzman, Esq.
  • Newsletters
  • Contact Us

Enter your email address to subscribe to this blog and receive notifications of new posts by email.

Join 5 other subscribers

© 1999 — 2012 Collins McDonald and Gann, P.C. All rights reserved. No reproduction without written permission. For information only; not to be construed as legal advice. ATTORNEY ADVERTISING This web site is designed to provide general information only and to help in the choice of appropriate legal counsel. The information contained herein should not be construed as legal advice. Legal jurisdictions differ on major and minor aspects of the law and each legal situation is unique; requiring that all legal situations be addressed with qualified legal counsel. Statutes and case law frequently change; the accuracy of this information can only be represented as of the date of publication. Prior results do not guarantee a similar outcome. Submitting or receiving information or questions through this web site does not create an attorney client relationship. No attorney client relationship will exist unless you meet with one of our attorneys and sign a retainer agreement. Please do not submit any information that is case specific, personal or confidential without prior approval. If you have legal problem or issue you should always consult with a qualified lawyer experienced in the appropriate area of law. We would be glad to discuss your specific situation with you, should you so desire, by phone at (516) 294-0300 or send us an e mail at info@cmgesq.com and we will respond to you. Principal Office located at 138 Mineola Blvd, Mineola, NY 11501.

EvoLve theme by Theme4Press  •  Powered by WordPress Collins, McDonald & Gann Supplement Counsel - Dietary Supplement and Sports Nutrition | Industry Counsel
Keeping Industry Ahead of the Curve

Back to Top
Contact Us