Posts by Mike DiMaggio

IMPORTANT UPDATE: Have You Renewed Your Registration?

Jun29th
2012 Leave a Comment Written by Mike DiMaggio

New Requirements for Registration of a Food Facility under the Food Safety Modernization Act

On Jan. 4th, 2011, the Food Safety Modernization Act (“FSMA”) was signed into law in an effort to enable FDA to better protect public health by strengthening the food safety system. The FSMA amends the Federal Food Drug and Cosmetic Act to give FDA new tools and authorities to monitor and inspect food importers and food facilities as well as to enforce the new requirements of verification and certification of applicable imported foods, with an overall goal of improving food safety. Under the Act, some of the new tools at FDA’s disposal include surveillance authority, detention of imports, suspension of food facility registrations and mandatory recall authority.

Expanding on the food facility registration requirements contained in the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, the FSMA requires additional information be submitted to FDA in order for the food facility to receive a registration number. While the new registration requirements are only one aspect of the FSMA, it is important that food facilities know how and when they must register and what information will be required. Dietary supplement manufacturers are considered food facilities and these registration requirements are expected to lead to an increase in inspections across the country. Below is an excerpt from the FDA’s Food Safety Modernization Act Frequently Asked Questions, which can be found at: http://www.fda.gov/Food/FoodSafety/FSMA/ucm247559.htm#registration READ MORE »

FDA, Regulatory FDA, Food Facility Registration Number, Food Safety Modernization Act, Public Health

FDA Warns RockStar, Inc.: “Coffee” Products are NOT Dietary Supplements and Contain an Unsafe Food Additive

Jun29th
2012 Leave a Comment Written by Mike DiMaggio

Re-visiting Issue of Supplements vs. Beverages

In a FDA Warning Letter for RockStar, Inc., referencing their January 3, 2012 inspection of the facility, FDA warned Rockstar, Inc. that several of their Rockstar Roasted Coffee & Energy products contained “unsafe food additives.” Once again focusing attention on the question of Supplements vs. Beverages, FDA concluded that Rockstars’ Rockstar Roasted Coffee & Energy Premium Blended Mocha Cream & Coffee, Rockstar Roasted Coffee & Energy Premium Blended Latte Cream & Coffee and Rockstar Roasted Coffee & Energy Light Vanilla, are not dietary supplements, although they are labeled as such, but are instead beverages, which are conventional foods. Because conventional foods are subject to the regulations that govern food additives, the only permitted food additives are those that are “Generally Recognized as Safe” or GRAS, unless they are the subject of a prior sanction. FDA concluded that Ginkgo biloba leaf extract (“Ginkgo”) is not GRAS for use as a food additive and therefore the inclusion of Ginkgo causes the products to be adulterated. The most troubling aspect of this letter are the facts and circumstances FDA relied upon in concluding that these products are conventional foods and not dietary supplements, despite the products’ labeling and the use of Supplement Facts Panel. This Warning Letter should serve as notice to companies that are seeking to market or currently marketing “energy drinks.” Product claims and even packaging can create enough ambiguity to draw the ire of FDA. Consult with qualified legal counsel and be sure to have your packaging, labels and marketing materials reviewed before going to market.

Dietary Supplements, FDA, Regulatory Beverages, dietary supplements, RockStar Inc.

Breaking News: Drums of Ephedrine Alkaloids seized by U.S. Marshals

Dec7th
2011 Leave a Comment Written by Mike DiMaggio

FDA issued a News Release yesterday stating that 4,000 pounds of raw material – Cissus quadrangularis and Cassia angustifolia extracts – found to contain “ephedrine alkaloids” were seized by U.S. Marshals. The allegation that these alkaloids were found in those raw materials is troubling and manufacturers should be on alert.

Read the full News Release below: READ MORE »

Dietary Supplements, FDA, Regulatory Cassia angustifolia, Cissus quadrangularis, FDA, Seized, US Marshals

New NDI “Grandfathering” Bill

Nov15th
2011 Leave a Comment Written by Mike DiMaggio

Will Congress exempt Pre-Jan. 2007 Dietary Supplements from New Dietary Ingredient (NDI) Regulations?

Rep. Dan Burton

Although we don’t yet know whether this legislation has any legs, on November 4^th Rep. Dan Burton (R-Ind.) proposed the H R 3380 – Burton, a bill that would grandfather tens of thousands of dietary supplement ingredients that have been marketed since the passage of DSHEA (October 15, 1994) up to January 1, 2007, effectively “reclassifying” their NDI status. Recognizing that industry practices, including the cGMP’s, Adverse Event Reporting, and voluntary product auditing and testing for quality and purity, have improved dietary supplement safety for consumers, the bill highlights that fact that corresponding FDA policy remained unchanged. The bill seeks to amend section 413(d) of the Federal Food, Drug, and Cosmetic Act (“FDC Act”) to expand the definition of a new dietary ingredient, because the FDC Act “does not recognize the current safe market in supplements, nor how intensively supplements have been regulated over the 17 years since enactment of DSHEA to protect public health and safety, and should be updated to reflect this reality.” We will be following the progress of this legislation in hopes that it will gain momentum and support from industry, and ultimately, from Congress.

Dietary Supplements, FDA, Regulatory Adverse Event Reporting, cGMP’s, FDA, H R 3380 - Burton, NDIs, supplement

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.

Dietary Supplements, FDA, Regulatory Draft Guidance, extension, FDA, NDIs, new dietary ingredients

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 15^th “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.

Dietary Supplements, Marketing and Advertising, Regulatory dietary supplement industry, GMP, NDIs, United Natural Products Alliance

The Natural Products Association Webinar: NDI Guidance: What You Need To Know

Jul12th
2011 Leave a Comment Written by Mike DiMaggio

Some insight and clarification offered from FDA but many questions left unanswered

The Natural Products Association hosted a Webinar featuring both an audio and video conference in the form of a slide show presentation. The Webinar featured two speakers, Dr. Daniel Fabricant, director of the Division of Dietary Supplement Programs at the FDA’s Center for Food Safety and Applied Nutrition (CFSAN), and Scott Bass, head of the Global Life Sciences Team at Sidley Austin LLP, followed by a Question and Answer segment. Dr. Fabricant began by providing an overview of the document as well as FDA’s position and thought process in preparing the draft guidance. Scott Bass then briefly presented his initial impressions based on his experience with the drafting and implementation of DSHEA. He also offered his interpretation of how this document will affect industry and some feedback that he has gathered from industry.

While Dr. Fabricant did not offer much clarification with respect to many of the questions posed by Bass and the teleconference participants during the Q & A segment, he should be commended for his efforts to address the barrage the of questions he received as the representative of FDA.
READ MORE »

Dietary Supplements, FDA, Regulatory Center for Food Safety and Applied Nutrition, CFSAN, dietary supplements, FDA, NDIs, new dietary ingredients

International Society of Sports Nutrition (ISSN) Conference and Expo

Jun27th
2011 Leave a Comment Written by Mike DiMaggio

The 8th Annual International Society of Sports Nutrition (ISSN) Conference and Expo was held this past weekend in Las Vegas. Once again, the successful program included presentations from many of the brightest minds in the fields of nutrition, exercise and human performance. The Keynote Lecture was presented by one of the key historic figures in the world of sports nutrition science, Dr. Roger Harris. Both Rick Collins and Alan Feldstein attended the conference as ISSN Legal Advisors.
READ MORE »

Uncategorized

BREAKING NEWS: MMA Legislation Passes the NY State Senate. Now on to the Assembly…

May23rd
2011 Leave a Comment Written by Mike DiMaggio

Received today from MMAFacts.com:

MMA Fans,

Big, big news today. The New York State Senate passed legislation sanctioning MMA throughout New York!

As exciting as this is, we now have to focus our efforts on the New York State Assembly.

Please take a couple minutes out of your day to call your local Assembly Member and urge him or her to pass this bill.

The bill is called A.04146 and the legislative session ends June 20th, so we have to act now to make this happen in less than 30 days!

This is a crucial moment in our campaign, and our calls will make a difference.

Great news for MMA fans who might finally get the opportunity to see MMA at MSG!

Uncategorized Mixed Martial Arts, MMA, New York

SUPPLYSIDE EAST FEATURED SPEAKER PRESENTATION: FDA Enforcement Actions and GMP Inspection Outcomes Highlighted

May13th
2011 Leave a Comment Written by Mike DiMaggio

Bradford W. Williams

May 2^nd to 4^th 2011 – Once again, SupplySide_® East, held at the Meadowlands Exposition Center in Secaucus, New Jersey, played host to thousands of folks involved in the food, beverage, cosmetic, personal care and dietary supplement industries. In addition to the nearly 300 exhibitor booths, SupplySide_® East also featured a variety of Speakers presenting on topics of interest to members of industry. Bradford W. Williams – presently the manager for the Division of Dietary Supplement Programs, Office of Nutrition, Labeling and Dietary Supplements, Center for Food Safety and Applied Nutrition (CFSAN), of the Food and Drug Administration (FDA) – focused much of his presentation on GMP Compliance and FDA’s inspection priorities as well as the major findings from the last 18 months of inspections.

According to Williams, FDA’s GMP inspection priority begins with manufacturers that blend and fabricate products, followed by companies that package and label finished products, and then entities that merely attach the product label. He indicated that FDA’s major findings included the following violations:

Inadequate or failure to conduct identity testing
Failure to establish specifications for components, ingredients, steps and stages of manufacturing and finished products
Failure to conduct testing to ensure product meets specifications
Failure to maintain adequate master manufacturing records (MMR) and Batch product records (BPR) content and recordkeeping requirements
Failure to conduct material reviews
Lack of adequate corrective action plans (CAP)

Williams indicated that after reviewing the 2010 FDA GMP inspections, the violation rate is estimated to be nearly 25%. Unfortunately, this is an indication that the industry is having a difficult time coming into compliance. If you have questions about the GMPs or need guidance on compliance measures, please call our office at (516) 294-0300.

Dietary Supplements, FDA, Marketing and Advertising Bradford W. Williams, Center for Food Safety and Applied Nutrition, CFSAN, FDA, Food and Drug Administration, GMP, GMP inspection, Supply Side East