It's Official: The Food Safety Modernization Act Is Law. What Food Companies Need to Do Right Now
President Obama signed into law today the Food Safety Modernization Act (FSMA).
Companies with facilities subject to FDA jurisdiction should take immediate steps to review and, where necessary, modify SOPs, policies and procedures.
For example, given the FDA's expanded access to business records, companies should set SOPs that anticipate (before a crisis occurs) what records they may have to turn over and what they may not. Food companies should take steps to protect confidential and proprietary information.
Companies also should anticipate now how they need to change their policies and approaches to mandatory recalls and whistleblower protections.
These parts of the legislation take effect today:
- Stronger records access authority by FDA (FSMA § 101)
- When FDA determines a "reasonable probability" of "serious adverse health consequences"
- FDA can access records of other food affected in a similar manner
- But FDA must show proper credentials and provide written notice
- Mandatory recall authority (FSMA § 206)
- FDA can order a recall if it finds a "reasonable probability" that
- food is adulterated or misbranded; and
- there may be serious adverse health consequences
- FDA has to provide an opportunity for a voluntary recall
- FDA will provide an informal hearing within two days of the order’s issuance
- FDA can order a recall if it finds a "reasonable probability" that
- Increased frequency of inspections (FSMA § 201)
- FDA will immediately increase the frequency of inspections
- FDA will apply a risk-based approach to determine priorities
- Whistleblower protection (FSMA § 402)
- Protects employees who:
- Provide information re violation of FDC Act ,
- Testify, assist or participate in a proceeding re a violation, and/or
- Object to "activity, policy, practice or assigned task" they "reasonably believe to be a violation"
- Protects employees who:
- Refused admission of imports if foreign facility refuses inspection (FSMA § 306)
- Foreign establishments must allow entry to U.S. inspectors within 24 hours of requesting entry
- Or imported food will be refused admission.
Future blog entries will discuss compliance with other provisions of the FSMA scheduled to be phased-in. If you are interested in a more detailed in-house discussion of the FSMA and its effect on your company, please let us know.
New FTC "Green Guides" Are Out of the Gate
Following several years of development, and much anticipation in recent months, the Federal Trade Commission has finally released “Proposed, Revised Green Guides.” The new Green Guides will be open for public comment until December 10, 2010. Thereafter, according to the agency’s press release, the FTC will determine if and how to issue the new Guides.
The proposed, revised Green Guides are summarized here and published with substantial analysis and comment here; the FTC invites submissions of public comments here.
The current official Green Guides, last updated in 1998, provide non-binding “interpretations” of federal consumer protection laws, including Section 5 of the FTC Act (15 U.S.C. § 45), which is the law that empowers the agency to punish deceptive practices. In general, the Guides establish that false or deceptive environmental marketing claims can be challenged under the FTC Act. The Green Guides also provide instruction and interpretations of marketing buzz words that were popular in 1998, such as “biodegradable,” “compostable,” “recyclable,” “refillable,” and “ozone safe.”
The proposed new Green Guides address the terms found in the 1998 edition, but also address several new issues that arise in present-day green marketing, including:
- environmental seals of approval,
- “free-of” and “non-toxic” claims,
- carbon offsets,
- claims concerning renewable energy, and
- claims about renewable materials.
The proposed Green Guides reinforce and restate the FTC’s reasonable policy position that environmental marketing claims should be supported by credible scientific evidence. In addition, the proposed Guides expressly discourage sweeping unqualified claims. For example, the Guides explain that an unqualified claim that a product is “eco-friendly” is inherently deceptive. In contrast, a simple clarification – if it can be substantiated – may be acceptable. The proposed Guides state that a claim such as “eco-friendly: made with recycled materials” is not deceptive if the clarification is prominent, and can be proven.
For the most part, the proposed Green Guides do not represent a radical shift from the 1998 version of the Guides. And on a careful reading of the revised Guides and the preceding 186 pages of analysis and comment provided by the FTC, it’s clear that the fundamental issue is deception. It’s deceptive to say your product has 50% more recycled contents than it used to, when your product only increases recycled content from 2 to 3 percent. It’s deceptive to mark your product with your own green “seal of approval” and not disclose that you made up the seal yourself. It’s deceptive to claim that you’ll plant trees to offset carbon emissions from your products, when it will take 10 years for the trees to get big enough to actually offset those emissions.
Ultimately, it does not appear that the FTC is proposing a major shift in regulations. The key question for any environmental marketing claim remains: is the claim “deceptive” under Section 5 of the FTC Act? The bigger question is, how will enforcement change? Last February, The New York Times reported that the FTC has filed seven complaints concerning environmental marketing claims since President Obama took office (compared to zero during the prior administration). If enforcement remains at that level, there cannot be substantial application of the new Green Guides. Then again, given the rapid growth of environmental marketing claims in recent years, the FTC’s renewed interest in this subject, and the threat of state consumer fraud actions, it would be imprudent to disregard the new Guides.
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.
News from Washington, D.C.
This was a relatively busy week in D.C. for dietary supplement legislation. First, a bill was introduced that would enable the FDA to better enforce the DSHEA, and second, a special Senate committee held a hearing on dietary supplement safety. Read more about each after the jump:
Continue Reading...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.
"Can You Really Afford To Do Business Without Politics?"
“I often hear people say that they will just focus on the business side of things and not worry with the politics, but the question is: can you really afford to do business without politics.” - Daniel Fabricant, PhD of the Natural Products Association. This is an interesting question presented in today's article on Nutra Ingredients-USA.com regarding lobbying for the nutrition industry, and what some insiders identify as excessive freeloading by U.S. nutrition companies.
The article presents the view that companies are not doing enough to let the industry's voice be heard in Washington, quoting one source saying that many display "all the characteristics of a parasite". To show the benefit of organized political efforts by nutrition-related companies, Suzanne Shelton gives the example of Senator McCain's withdrawal of support from S.3002 but warns that the industry needs to step up to avoid losing advocates like Senator Orrin Hatch and Congressman Frank Palone Jr.
So industry insiders, is lobbying a necessary component of growth and stability for the nutrition industry?
Thanks to Tyler Anderson of the Food Liability Law Blog for forwarding the article.
Good News on Senator McCain's S.3002, the Dietary Supplement Safety Act?
The dietary supplement industry received good news when Senator John McCain recently backed away from a bill that would have given the FDA greater authority to regulate the industry. Senator Orin Hatch, who had been critical of the bill, thanked Senator McCain for withdrawing the bill.
Here's a copy of Senator Hatch's letter to Senator McCain: 
