Posts Tagged ‘dietary supplements’
Alan Feldstein Presented at the American Herbal Products Association Webinar
Alan Feldstein
Dietary supplement law expert Alan Feldstein presented at the American Herbal Products Association webinar last week to address issues surrounding the FDA’s controversial new draft guidance on NDIs (new dietary ingredients). In his presentation, Feldstein noted that not only is there “no logic” to FDA’s guidance regarding some of these notifications, but cautioned that this insistence would place “an impossible burden on the industry.” Read the news story published by Nutraingredients USA on this timely and critical topic, click HERE.
To see Alan’s complete presentation, click here: Webinar Presentation 7-19-11.
The Natural Products Association Webinar: NDI Guidance: What You Need To Know
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Fabricant began by providing an overview of the document as well as FDA’s position and thought process in preparing the draft guidance.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 the rest of this entry »
CMG will be at Supply Side East – May 4th, 2011 – Meadowlands Exposition Center – Secaucus, N.J.
On Wednesday, May 4th Mike DiMaggio will be attending Supply Side East on behalf of Collins, McDonald & Gann. Supply Side East is an important trade show for cosmeceutical, food, beverage and supplement product developers, marketers and formulators. It offers the opportunity to meet hundreds of exhibitors offering thousands of innovative and healthy ingredients! In addition to meeting with clients and colleagues, Mike will be walking the floor of the Expo and attending several of the seminars. Of particular interest are the seminars hosted by Vasilios Frankos, Ph.D., who recently retired from the U.S. Food and Drug Administration where he served as the director, division of dietary supplements programs, Center for Food Safety and Applied Nutrition (CFSAN). Dr. Frankos was the lead scientist for dietary supplements for the FDA and was responsible for the full implementation of the DSHEA Act of 1994. He directed and coordinated policy and administrative activities within the division, and advised on policy and management issues on dietary supplement programs, new dietary ingredient safety assessments, good manufacturing practice, adverse reaction monitoring and related activities pertaining to dietary supplements. Dr. Frankos is currently the senior vice president for global product science, safety and compliance, Herbalife Intl., and now that he has had a chance to experience the life of the regulated rather than the regulator, in his presentation he will share his thoughts and observations on the regulatory/scientific state of the dietary supplement industry from both sides of the fence, aptly titled, An FDA Insider’s View of the Dietary Supplement Industry from the Other Side of the Fence.
Also of particular interest will be the presentation of Featured Speaker Bradford W. Williams, who is the current manager of the division of dietary supplement programs for FDA. His presentation is entitled, FDA Update on GMP Inspections and DSHEA, in which he will be sharing the agency’s observations from GMP inspections and will talk about how industry is doing now that compliance is required and what areas are of the most concern to the FDA.
“TIMES THEY ARE A-CHANGIN’” Supplement GMPs are in Full Effect
June 25, 2010 – Today marks the date by which small businesses, meaning dietary supplement manufacturers with less than 20 employees, must be compliant with the current Good Manufacturing Practices (cGMPs) for dietary and nutritional supplements. It has been nearly 16 years since the Dietary Supplement Health and Education Act (DSHEA) was passed. DSHEA contained a provision requiring that FDA establish and enforce cGMPs, and while drafts were presented for comment over the years, it was not until 2007 that the cGMPs were finally approved, along with a three phase process for enactment, the final phase taking effect today. Read the rest of this entry »
New Dietary Guidelines for America
This week, Agriculture Secretary Tom Vilsack and Health and Human Services Secretary Kathleen Sebelius released a draft report entitled the Report of the Dietary Guidelines Advisory Committee on the Dietary Guidelines for Americans, 2010. In the face of widespread dietary misinformation and an epidemic of obesity, the draft report examines both what Americans are eating and what we should be eating, based on the existing science. Written comments on the draft are welcome, and are encouraged to be submitted through July 15, 2010. Oral testimony may be provided at a July 8 public meeting in Washington, DC. When it’s finalized and released at the end of the year, the report will be the basis for the 2010 Dietary Guidelines for Americans and replace the 2005 Dietary Guidelines.
Protein Drinks are Dangerous, Says Consumer Reports
The July 2010 issue of Consumer Reports (CR) magazine investigates protein drinks with not very flattering findings:
… [O]ur investigation, including tests at an outside laboratory of 15 protein drinks, a review of government documents, and interviews with health and fitness experts and consumers, found most people already get enough protein, and there are far better and cheaper ways to add more if it’s needed. Some protein drinks can even pose health risks, including exposure to potentially harmful heavy metals, if consumed frequently. All drinks in our tests had at least one sample containing one or more of the following contaminants: arsenic, cadmium, lead, and mercury. Those metals can have toxic effects on several organs in the body.
It’ll take some time to fully dissect the findings. Obviously, nobody needs to ingest unsafe levels of heavy metals. But 12 of the 15 did not contain unacceptable levels of any heavy metals in a full three (3) servings daily. Of the 3 that did show unacceptable levels, again, it was only at 3 servings daily, not one or 2. Only one product had levels of arsenic above the proposed USP limit. Further, the USP limits are based on a person weighing only 110 pounds — considerably less than many if not most protein shake drinkers. Read the rest of this entry »
CRIMINAL CHARGES FOR EXECUTIVES: PART OF NEW FDA INITIATIVE
Dr. Margaret Hamburg
In a March 4th letter to Senator Chuck Grassley, the Ranking Member of the Committee on Finance, Commissioner Margaret Hamburg indicated that FDA plans to “increase the appropriate use of misdemeanor prosecutions … to hold responsible corporate officers accountable” and has developed a yet to be released criteria for determining when these criminal prosecutions will be used. This letter was in response to a report released by the Government Accountability Office (GAO) entitled: Food and Drug Administration: Improved Monitoring and Development of Performance Measures Needed to Strengthen Oversight of Criminal Misconduct Investigations. Read the rest of this entry »
McCain’s Proposed Bill & the Sports Nutrition Industry
John McCain (R-Ariz.) announced in a press conference that he intends to introduce new legislation which would effectively amend the Food, Drug & Cosmetic Act, particularly with respect to DSHEA. Click here to see the full text of proposed legislation.
We intend to further analyze this legislation; however, our initial impression is that we cannot see this bill passing without substantial modifications. Here are the highlights. The amendments proposed in McCain’s legislation could certainly be interpreted as throwing out the idea of “grandfathered” ingredients in favor of a list of “acceptable dietary ingredients” which would seem to suggest that FDA will be quite busy assessing all of the dietary ingredients marketed in the United States in order to determine whether they are “reasonably expected to be safe.” Either that or they are going to start from scratch and require every company to just begin filing these notification packets for every single dietary ingredient they currently sell…that shouldn’t take too long for FDA to review. Obviously this issue would require substantial clarification as the legislation retains the term “New Dietary Ingredient” but seems to remove the old section about ingredients marketed prior to 1994, which is what establishes the basis for the “old” or “grandfathered” dietary ingredients.
New Report… CBS NEWS: “The ‘Legal’ Steroid Danger”
Sports nutrition supplements are back in the news and once again it’s not a positive story. Today CBS News ran a story entitled, “The ‘Legal’ Steroid Danger,” which featured several dietary supplement products that contain the substance 19-Norandrosta 4,9 diene- 3,17 dione (also known as Estra-4,9-dien-3,17-dione), which is purportedly a progestin similar to trenbolone, nandrolone and methyltrienolone.
New GAO Report May Bring Heightened Oversight of Supplements
The General Accountability Office (GAO) recently released a report to Congressional requesters on the issue of whether “FDA should take further actions to improve oversight and consumer understanding” of dietary supplements. In recommending that the Secretary of Health and Human Services direct the FDA Commissioner to request additional authority to oversee dietary supplements, one of the key areas of GAO focus was adverse event reporting.The report recommends requiring that all supplement adverse events be reported, not just serious ones, and that supplement companies register annually as such and maintain records of their products and labels.
