Posts Tagged ‘dietary supplement regulation’
Additional FTC Powers NOT Part of Wall Street Reform Bill (S. 3217)
In a House and Senate conference of the Wall Street Reform Bill and Consumer Protection Act, conferees ultimately decided not to include the broad rulemaking authority granted to the Federal Trade Commission (FTC) in the House version of the bill advocated by Congressman Henry Waxman (D-CA). This is a huge win for the nutritional supplement industry, as the rulemaking authority that would have been bestowed on FTC could have had a dramatic impact on industry, allowing the Agency to issue Rules under the Administrative Procedures Act that directly and significantly affect advertising. Currently FTC primarily “makes law” through enforcement of existing law. Getting this proposal removed from the final legislation was achieved through the help of overwhelming grassroots support in the form of messages from constituents to their representatives, and a combined effort of industry trade organizations including NPA and AHPA educating consumers and lobbying Capital Hill. I am proud to say that I personally spent a day on the Hill meeting with Representatives and U.S. Senators from New York and California, educating them on the issues and advocating on behalf of industry.
“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 »
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 »
New Steroid Law Still En Route?
Some law-makers in Washington have been asking, how did “hidden steroids” get into bodybuilding supplements when the amended steroid law of 2004 was supposed to have solved the problem? Supplement industry critic Senator Arlen Specter [D-PA] chaired a Senate subcommittee hearing last September (http://judiciary.senate.gov/hearings/hearing.cfm?id=4081) to get some answers from DEA and FDA brass. The Senator appeared committed to solving the problem by reportedly working on a bill tentatively entitled the “Designer Anabolic Steroid Control Act of 2010.” Read the rest of this entry »
U.S. Senate Committee Hearing on Supplements set for May 26
The Senate Special Committee on Aging has scheduled a hearing entitled, “Dietary Supplements: What Seniors Need to Know.” The hearing, scheduled for 2 pm on Wednesday, May 26, 2010, will include testimony from the General Accountability Office concerning its investigation into “marketing practices” for herbal supplements. Although the focus may be on the potential interactions between herbal products and prescription drugs, speculation is that questions about ”New Dietary Ingredients” may also be a highlight. Go to http://aging.senate.gov/ on the day and time of the hearing to view the live webcast.
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 »
John McCain Backs off Anti-Supplement Legislation
After offering the Dietary Supplement Safety Act of 2010, S. 3002, last month to more closely regulate and restrict the supplement industry, Arizona Senator John McCain reportedly has withdrawn his support for the bill and will now work with Senator Orrin Hatch of Utah on a revised legislative initiative. McCain’s bill was applauded by anti-doping agencies but was perceived as excessively and unnecessarily onerous on industry. Hatch had expressed “serious concerns” about the bill in a March 4 letter to Sen. McCain. A timeline for the new bill is not set.
CRIMINAL CHARGES FOR FALSE CLAIMS: Supplement Company Owner Pleads Guilty to Fraudulently Marketing Dietary Supplements
Making claims that a dietary supplement product can treat, cure or prevent a disease; making claims that are not substantiated or even worse, claiming that clinical studies have been performed when in fact, they have not, can result in substantial forfeiture of assets and federal criminal charges. The supplement industry is familiar with FDA and FTC oversight of dietary supplement claims resulting in consent decrees and civil penalties for violations of federal regulations. But what companies are not as familiar with are FDA’s enforcement powers to launch criminal investigations which are prosecuted by the United States Attorney’s office. Below is a recent example of the kinds of penalties that not only companies but individuals can be subject to for making false claims about supplement products. CMG works with our clients to review their label and advertising claims for compliance with federal laws and regulations, to help prevent or avoid this kind of situation from occurring:
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.
FDA Commissioner Hamburg’s Speech and the Potential Impact on the Supplement Industry
Recently Rick Collins and Alan Feldstein gave a speech at the ISSN conference in New Orleans on the effect the new Administration will have on our industry. They spoke about their belief that there will be greater regulatory scrutiny and more enforcement of dietary supplements, especially in the sports nutrition category.They emphasized the need to strictly comply with the law and to make sure that all dietary supplement products are substantiated, manufactured and marketed appropriately, and in fact actually fall within the definitional requirements for dietary supplement products as enunciated in DSHEA.
Those thoughts and opinions have now been echoed Margaret Hamburg, M.D., the newly appointed FDA Commissioner, during a recent speech at an industry sponsored conference.
