2010 Wrap-Up
With 2011 nearly upon us, we have taken a look back at the news from 2010 and the posts from the inaugural year of the Essential Nutrition Law Blog and have created a list of what we feel were the top five news stories affecting the nutrition industry in 2010. Below are our choices, in no particular order. Feel free to weigh in in the comments.
1. Senator McCain’s “Dietary Supplement Safety Act”. We began the year with the threat of more stringent regulations for dietary supplement manufacturers under a bill backed by Senator McCain. The Senator backed away from the bill in March, much to the delight of Senator Orrin Hatch. This was, of course, great news for the industry.
2. Litigation for False Claims and Deceptive Advertising. We saw a number of high-profile cases in 2010 where companies were sued for false claims or deceptive advertising in connection with dietary supplements and functional foods. For example, Dannon will pay 66 million to settle a class action suit and an action brought by the attorneys general of 35 states, the FTC put an end to some claims regarding acai berries, consumers sued Coca-Cola for claims made related to Vitamin Water, and a U.S. Attorney in Wisconsin brought suit against Beehive Botanicals, resulting in federal officials seizing a number of products from the company.
3. The FDA begins enforcing GMP’s. In May, the FDA sent out its first warning letter related to a GMP inspection, indicating that the FDA is finally enforcing the GMP regulations first announced in 2007. For tips on preparing for a GMP inspection, read Jonathan Stagg's post here.
4. The November Elections. The November elections shook things up in Washington, especially in the House of Representatives, where we saw the largest shift in party control in over six decades. There has been much speculation over how this will affect legislation for the remainder of President Obama’s first term in office. In addition, most analysts predict that the results of the 2010 Census will likely favor Republicans. This change could obviously alter how the nutrition industry is perceived by federal lawmakers, and could affect legislative efforts like the Dietary Supplement Safety Act.
5. Passage of the Food Safety Bill. The year ended with the Senate passing the Food Safety Modernization Act which updates the food regulations that have been around for over 70 years. Assuming President Obama signs the Bill into law, it will bolster the FDA's ability to monitor food imports and will shift the regulatory focus to the prevention of contamination. The dietary supplement industry generally welcomes the update. For more in-depth coverage of the Food Safety Bill, visit the Food Liability Law Blog.
Stoel Rives and ACC Mountain West To Host Nutrition Law Symposium
For more information, contact Melanie Williamson, Stoel Rives Business Development Coordinator, at (801) 715-6662 or mwwilliamson@stoel.com.
Canada: Temporary Relief for Unlicensed Supplements
The Canadian government recently proposed a temporary solution to allow continued sales of unlicensed Natural Health Products (NHPs). The proposed regulations, titled “Natural Health Products (Unprocessed Product License Applications) Regulations” (the “Proposed Regulations”) provide an exemption for some unlicensed NHPs that have pending applications for licensure.
Under current Canadian regulations, NHPs must be licensed. There is currently a backlog of approximately 10,000 unlicensed NHPs on the market in Canada that have applications pending to receive regulatory approval. In January of this year, the National Association of Pharmacy Regulatory Authorities issued a statement urging pharmacies to halt sales of unlicensed NHPs because such products posed a risk to public safety. Some pharmacies adopted this position, cutting off market access for some manufacturers.
The Proposed Regulations would allow continued sales of unlicensed NHPs in some situations. To qualify, a manufacturer must have an application on file with Health Canada that has been pending for more than 180 days and the product must meet certain safety requirements. If implemented, the Minister of Health would notify an applicant that an exemption number has been assigned. Within thirty days of this notice, the applicant must consents to having its exemption information posted on the Health Canada website and must verify that the product meets certain safety and use criteria (for example that it is not intended for use by children or women who are pregnant or nursing and does not contain harmful or prohibited ingredients).
Once an applicant provides consent and verification, the NHP will be deemed to hold a license, allowing the product to be sold legally. Manufacturers will be required to display the exemption number (rather than an NHP number) on product labels. The Proposed Regulations give manufacturers 12 months or until the next label run to comply with the labeling requirements. Manufacturers must also comply with other safety requirements imposed by Canadian “Natural Health Products Regulations”, but will not share in all of the rights provided to licensees under such regulations.
Note that deemed licenses provide only temporary relief. The Proposed Regulations will be in force for 30 months after becoming effective. Therefore, manufacturers will still need to complete the licensing process. For those whose Canadian applications are stuck in queue, however, the Proposed Regulations should provide some relief.
Steve Mister of CRN: We Need "Better Enforcement of the Law, Not a Rewrite of It"
Steve Mister, President and CEO of the Council for Responsible Nutrition, authored an op-ed article for USA Today where he argues that the current laws regulating dietary supplements are effective, but need better enforcement. According to Mr. Mister, the dietary supplement industry supports full implementation of the laws as a way to weed out the few unethical practices and companies from an otherwise legitimate industry. The article is part of Mr. Mister's efforts to promote the passage of the Dietary Supplement Full Implementation and Enforcement Act and CRN's efforts to promote compliance and ethical practices in the industry.
Will the New Health Care Law Improve Chilren's Nutrition?
It is hard to deny that Americans are putting on the pounds and that the problem is often starting with poor nutrition during childhood. The problem has not gone unnoticed and a number of organizations, including the federal government, are trying to trim down the epidemic.
Authors Ellen-Marie Whelan , Lesley Russell, and Sonia Sekhar of the Center for American Progress recently published the report, "Confronting America's Childhood Obesity Epidemic: How the Health Care Reform Law Will Help Prevent and Reduce Obesity" (link to website introducing the report, with links to the full version and executive summary). As is clear from the title, the report analyzes the potential effect of the new health care reform laws on children's nutrition. Specifically, the authors discuss the Patient Protection and Affordable Care Act and highlight the following provisions as those with the most effective measures for combating childhood obesity:
- Improved nutrition labeling in fast food restaurants, which will list calories and provide information on other nutrients (For more information on this specific provision, take a look at Richard Goldfarb's excellent post with his thoughts on the new labeling requirement).
- The Childhood Obesity Demonstration Project, which gives grants to community-based obesity intervention programs
- Community Transformation Grants, which gives grants to community-based efforts to prevent chronic diseases
The report also analyzes a number of other aspects of the law that, while not targeted specifically at combating obesity, the authors believe will have some positive effect on the problem.
Update on Vermont's Vitamin Tax
It looks like Vermonters likely won't be paying any extra for their vitamins and dietary supplements. As we previously posted, the Vermont House of Representatives passed a bill last month that, among many other things, would impose a 6% sales tax on all dietary supplements sold in the state. On April 23, the Vermont Senate amended the bill to remove the tax. Other sources report that the Senate panel recognized that a tax on supplements would penalize Vermonters who wish to improve their health. The bill must now go back to the House for reconciliation with the Senate's version.
Vermont's (Potential) Vitamin Tax
The Vermont Senate is considering a bill passed in the state’s House of Representatives that would add a 6% sales tax on dietary supplements sold in the state. The provision is part of an Act (pdf file) that would modify Vermont tax provisions in an effort to keep education tax rates flat. WCAX.com reports that the tax on supplements would raise about $1.5 million dollars. The Senate Finance Committee is currently holding hearings regarding the bill, including an April 8th hearing with testimony specifically regarding the dietary supplement tax.
Interestingly, Vermont has been in the forefront of the “junk food tax” issue, with at least two bills introduced in the House that would tax soft drink sales. A dietary supplement tax would likely undermine the state’s position of promoting its citizens’ health and nutrition, and perhaps instead portray Vermont as a state simply looking for more tax revenue.
Welcome to the Essential Nutrition Law Blog
Welcome to the first day of our blog devoted to nutrition law. Nutrition law is one of my passions partly because I appreciate the role that nutrition plays in improving health and life, which I seem to be more concerned about today than I was ten years ago. I was happy to see this optimism supported in a recent ScienceDaily article. The rules and regulations that govern how nutrition products are made, marketed and sold is also a passion and just as important to the individuals and companies involved in this business.
We’re not the first or only blog to address topics related to nutrition law. I like to read Joel Rothman’s Nutritional and Dietary Supplement Law Blog, and my colleague Ken Odza maintains an interesting blog on Food Liability Law. But I hope that our passion and experience in this field will produce valuable content that will have you coming back often.
