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Thanks to reader Michael Bulger for forwarding the Senate staff analysis of the impact of S. 510 on small farms.   Here’s what it says (slightly edited):

No Change in Agency for Regulated Foods: Only foods already regulated by the Food and Drug Administration (FDA) will be subject to S. 510. Section 403 maintains the existing firewall between FDA and the U.S. Department of Agriculture regulated foods and agricultural products.

No Change in Definition of Facility: Under the Bioterrorism Act of 2002, certain food businesses were considered “facilities” and had to register with FDA. Farms and restaurants were exempted. This definition is not changed in S. 510. If an entity does not need to register now, it will not need to register under S. 510.

Flexibility for Small Businesses: Small businesses are given regulatory flexibility throughout S. 510. For example, small processors are given additional time to comply with new food safety practices and guidelines created by the bill and the Secretary may modify or exempt small processors from new hazard analysis and preventive control requirements based on size and risk. The legislation also requires the FDA to publish several user-friendly small entity compliance guides to assist firms with the implementation of new practices.

Scale Appropriate Produce Safety Standards: In coordination with the Secretary of Agriculture, FDA develops science-based standards for the safe production and harvesting of fruits and vegetables. Priority is given to specific fruits and vegetables that have the highest risk of food borne illness outbreaks. Flexibility is given for different growing, production, and harvesting techniques. FDA has the discretion to limit produce safety standards for small and very small entities that produce or harvest food which pose little or no serious risk to human health. Consideration is also given to conservation and environmental standards already established by federal natural resource and wildlife agencies. Exemptions are also available for low risk commodities. FDA must minimize the burden of paperwork and, as appropriate, the number of separate standards for separate foods.

Increased Training Opportunities: The bill requires FDA to coordinate with the extension activities of the National Institute of Food and Agriculture (NIFA) of the U.S. Department of Agriculture in educating growers and small processors about any new practices required by S. 510. Necessary funds are authorized to conduct these extension activities. The bill also provides for the training and education of state, local, and tribal authorities to facilitate the implementation of new standards under the FDA Food Safety Modernization Act. Competitive grants are made available, for up to 3 years, to support these efforts to enhance education, training, and technical assistance.

Risk-Based Traceability: The ability to trace back potentially unsafe food in the event of a food-borne illness outbreak is important. For the purpose of traceability, farms and small businesses that are not food facilities are not expected to create new records. During an active investigation of a foodborne illness outbreak, in consultation with state and local officials, the Secretary may ask a farm to identify potential immediate recipients of food if it is necessary to protect public health or mitigate a foodborne illness outbreak. Limitations are also included for restaurants, commingled agricultural commodities, direct to consumer sales, fishing vessels and products carrying an identity preserved label.

Regulatory Flexibility for Organic Foods: Throughout the bill, consideration is given to the unique agricultural practices and requirements of organic foods under the Organic Foods Production Act of 1990.

Protections for Farmers Markets, Cottage Industries and Direct Farm-to-Market Sales: Small entities that produce food for their own consumption or market the majority of their food directly to consumers or restaurants are not subject to registration or new recordkeeping requirements under S. 510. This includes food sold through farmers’ markets, bake sales, public events and organizational fundraisers.

I hope this helps to calm things down a bit.  This bill needs all the support it can get.  It’s not perfect but it is a reasonable first step, and badly needed.

The Farmers Legal Action Group has a new report out analyzing the 2008 Farm Bill and explaining what needs to happen to bring our agricultural policies in line with public health policies.  The report has a title that warms my heart, “Planting the Seeds for Public Health.” Its subtitle: “How the farm bill can help farmers to produce and distribute healthy foods.”

Its main findings:

• Fruit and vegetable farmers lack a safety net to protect them from natural disasters in a manner comparable to programs that are available for farmers producing major commodity crops, such as corn, soybeans and wheat;
• Crop insurance, disaster assistance, and loan and conservation programs are not designed to address the unique characteristics of fruit and vegetable production and marketing; and
• Nutrition program expenditures are not adequately directed to ensure children, including those from low-income households, receive healthy food.

And one key observation: many of the recommended changes could be made by the USDA without the need for additional direction from Congress.  Translation: No need to wait until 2012 when the Farm Bill comes up again.

USDA could do a lot of this NOW!

While I’m on the subject of the FTC (see yesterday’s post), let’s congratulate the agency for going after the Nestlé (no relation) corporation for marketing a product aimed at kids with misleading, deceptive, and—according to the FDA—illegal health claims.  The FTC settlement announcement says that

from fall 2008 to fall 2009, Nestlé HealthCare Nutrition, Inc. made deceptive claims in television, magazine, and print ads that BOOST Kid Essentials prevents upper respiratory tract infections in children, protects against colds and flu by strengthening the immune system, and reduces absences from daycare or school due to illness.

Nestlé must have introduced this product in 2008 because bloggers (of the sponsored kind) were promoting its benefits in September that year.  One said:

BOOST Kid Essentials is a nutritionally complete drink intended for children ages 1 to 13.  The probiotics in BOOST Kid Essentials are embedded in a straw that comes with the drink, which was prominently featured in ads for the product.  Probiotics are live, beneficial bacteria that are found naturally in many foods, and they are known for aiding digestion and fighting harmful bacteria.

This blogger’s enthusiasm for the product—“parenting solved”—quotes two studies, one done with adults using the straw and another with kids in day care whose infant formula was supplemented with one of the bacteria used in the adult study.  Both studies look preliminary to me, as they must have to the FTC.

In February 2009, in what reads like a company advertisement, another (sponsored) blogger wrote:

BOOST Kid Essentials Drink is the only nutritionally complete drink that provides kids ages 1 through 13 with immune-strengthening probiotics plus complete, balanced nutrition. Just one daily serving of the probiotic found in the BOOST Kid Essentials Drink straw has been clinically shown to help strengthen the immune system. BOOST Kid Essentials Drink is perfect for children who are below growth percentiles, having trouble gaining weight, resisting eating enough nutritious foods, or needing extra nutrition to help maintain an active lifestyle.

But in December 2009, the FDA  issued a letter to the company warning it that it was marketing this product as a drug:

this product is misbranded under…the Federal Food, Drug, and Cosmetic Act… because the label is false or misleading in that the product is labeled and marketed as a medical food but does not meet the statutory definition of a medical food in the Orphan Drug Act…Furthermore, this product is promoted for conditions that cause it to be a drug under section 201(g)(1)(B) of the Act…The therapeutic claims on your website establish that this product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease.

The warning letter didn’t get into the business of whether probiotics really do any good (the European Food Safety Authority certainly doesn’t think so) or whether “healthy” bacteria stay live and active in a straw stuck in the packaging of a kids’ drink.  The company must not have wanted to get into all that, so it settled.  The probiotic straw no longer comes with the package.

Nestlé is the largest food company in the world with earnings that exceed $100 billion annually.  It should have known better.

Update, July 15: Since the FTC imposed no penalties on Nestlé,  analysts expect class action lawsuits to follow in due course.  And here’s the account in the New York Times (I’m quoted).

A reporter sent me this message from Christopher Perille, Mead-Johnson’s Vice President – Corporate Communications & Public Affairs, about the company’s Chocolate and Vanilla sweetened Enfagrow toddler formula, advertised with health claims.  It seems only fair to present the company’s defense of its products.  Here’s what he says:

Enfagrow Premium products contain a balanced blend of protein, fat, carbohydrates and other key nutrients, offered in a form designed to be appealing to even the pickiest eaters. These products were introduced in the U.S. to provide additional nutrition as part of a normal healthy diet for toddlers who have been weaned off breast milk or infant formula. While we recognize that each toddler — and his or her eating habits and nutritional needs — are different, they can often have rather narrow palettes and relatively short lists of acceptable foods. My daughter, for one, had an extended period of time during which hot dogs, chicken fingers and french fries were three of her primary food groups. Happily, her tastes eventually expanded, and she is now a healthy and happy sophomore at Washington University in St. Louis — but there was certainly a time when I was concerned whether or not she was getting all the nutrition she needed.

Enfagrow Premium vanilla has been in the marketplace for nearly a year and has elicited numerous positive comments from grateful parents. They have told us that they consider these products an important option for helping to meet their child’s overall nutritional needs, especially those who are picky or erratic eaters, so as to help provide additional assurance that toddlers achieve their recommended nutrient intake.

As we discussed, you were looking at older packaging. The current labeling for Enfagrow Premium vanilla, indicates 17 grams of total sugar, but even that is overstated due to precautionary rounding — the real figure probably falls closer to 15 (14-16). The majority (approximately three-quarters) of the sugar in our product comes from lactose (that is naturally occurring in milk). So while we do add a small amount of sugar (about 4 grams or 1 teaspoon in a 7 fl. oz. serving) to our Enfamil Premium vanilla product to improve the for finicky eaters, the sugar in our flavoring equates to about 15 calories and is less than 2% of a toddler’s daily allowance of calories.

By comparison, the chocolate-flavored version contained less lactose and required more added sugar to overcome the bitterness of cocoa to make it palatable, so the sugar from lactose accounted for just over half the total sugar.

Even with the added 15 calories of sweetness, Enfagrow Premium vanilla has a superior nutritional profile to many other beverages regularly consumed by toddlers – including apple juice, grape juice and similarly flavored dairy drinks.

Enfagrow products also have beneficial ingredients include iron to help support brain growth and antioxidants and other nutrients to help support the immune system. Additionally these products are also a source of Omega-3 DHA and prebiotics, both of which are lacking in milk. Finally, these products exceed whole milk – serving for serving – for important vitamins such as A, B1, B6, C and E.

Enfagrow Premium products – flavored and unflavored – can be part of a balanced diet, which in combination with routine physical activity and an overall healthy lifestyle, can help avoid obesity. In fact, a peer reviewed article published in April 2008 in the Journal of the American Dietetic Association – based on a study of over 7,500 children and adolescents from ages 2 to 18 – found that consumption of either flavored or plain milk is associated with a positive influence on nutrient intakes by children and adolescents. Additionally, consumption of flavored milk was not associated with adverse effects on Body Mass Index (BMI), a commonly used indicator of obesity.

Convinced?  I’ve said all I have to say about these products in previous posts.  You decide.

I keep complaining about the health claims on Enfagrow toddler formula, a sugary product aimed at children from ages one to three:

These claims, for the uninitiated, are a special kind called structure-function.  Congress authorized such claims when it passed the Dietary Supplement Health and Education Act (DSHEA) in 1994.

Structure-function claims do not say that the product can prevent or treat disease. They merely suggest that the product can help in some unspecified way with some structure or function of the body.

When Congress passed DSHEA, it meant the claims to apply to dietary supplements, not foods. Enfagrow is marketed as a food, not a supplement.  It displays a Nutrition Facts label, not a Supplement Facts label.

Over the years, the FDA has issued cease-and-desist warnings about foods that bear structure-function claims.  In recent years, it has simply stated that manufacturers are responsible for ensuring that the claims are “truthful and not misleading.”

One reason for the shift is what the Courts have ruled.  The Courts say that structure-function claims are protected by First Amendment guarantees of free speech.  The most recent case is Alliance for Natural Health USA v. Sebelius. As described in Food Chemical News (June 7), a D.C. District Court judge ruled that the FDA cannot deny health claims that link selenium supplements to reduced risk of several diseases, or require those claims to be qualified, just because the claims lack adequate scientific substantiation.

In other words, supplement makers can say anything they want to about the benefits of their products—on the grounds of free commercial speech—whether or not science backs up the claim.

Recently, the FDA issued a warning letter to Nestlé, the maker of a Juicy Juice product aimed at toddlers, which displays a claim that its content of added omega-3 DHA improves brain development.  The FDA did not take on the claim, even though research seems unlikely to find that such drinks have any special benefits for brain development.  Instead, the FDA focused on a technicality:

The product makes claims such as “no sugar added,” which are not allowed on products intended for children under 2 yrs of age because appropriate dietary levels have not been established for children in this age range.

I’m guessing—this is speculation—that the FDA is reluctant to take on Enfagrow’s brain or immunity claims because Mead-Johnson has deep pockets and might well be willing to fight this one in court as a First Amendment case.

I am not a lawyer but I thought that intent mattered in legal cases.  Surely, the intent of the founding fathers in creating the First Amendment was to protect the right of individual citizens to speak freely about their political and religious beliefs.  Surely, their intent had nothing to do with protecting the rights of supplement, food, and drug corporations to claim benefits for unproven remedies, or to promote sales of sugary foods to babies.

I think it is time to give these First Amendment issues some serious thought.  How about:

• FDA: Fire those lawyers and hire some who will protect the FDA’s ability to use science in its decisions.
• FTC: Take a look a the immunity claim on the Enfagrow Vanilla toddler formula, now that the Chocolate is off the market.
• Legal scholars: Surely there are ways to protect real First Amendment rights while restricting unsubstantiated health claims?

Other ideas are most welcome.  Your thoughts?

Mead Johnson announced yesterday that it was withdrawing its Enfagrow Chocolate Toddler Formula–just the Chocolate version–from the market:

Like all our Enfagrow Premium products, the recently introduced chocolate-flavored version has a superior nutritional profile to many other beverages typically consumed by toddlers — including apple juice, grape juice, and similarly flavored dairy drinks. Unfortunately, there has been some misunderstanding and mischaracterization regarding the intended consumer for this product and the proper role it can play in a child’s balanced diet. The resulting debate has distracted attention from the overall benefits of the brand, so we have decided to discontinue production of Enfagrow Premium chocolate toddler drink and phase it out over the coming weeks.

I can’t resist quoting the Chicago Tribune’s explanation of the origin of the debate caused by “misunderstanding and mischaracterization:”

Introduced in February, the chocolate-flavored formula was widely criticized in the blogosphere after Marion Nestle, professor of nutrition, food studies and public health at New York University, wrote that the drink would lead children to crave sugary beverages on her influential blog, www.foodpolitics.com.

Influential?  Maybe, but it seems that my comments on this formula did not go nearly far enough.  Mead-Johnson may be withdrawing the Chocolate version, but it is keeping the Vanilla (as explained by Susan James on ABCNews.com, which also quotes me).

What’s the difference?  The Vanilla has exactly one gram less sugar than the Chocolate, 18 grams per 6-ounce serving, rather than 19 grams.  In contrast, the milk in my refrigerator has 9 grams of sugar (natural, not added) in 6 ounces.

Clearly, Mead-Johnson doesn’t get that it’s the sugars, stupid.

Why do I think this is a PR stunt?  Three reasons:

• The Vanilla doubles the sugars in regular milk.
• The Vanilla has the same health claims as the Chocolate: growth, brain development, and immunity.
• Mead-Johnson’s stock went up after the announcement.

One more time: Where are the FDA and FTC on this product?  This Immunity claim is no different from the one on Kellogg’s Krispies cereals that the FTC went after a couple of days ago.

Tomorrow: Some speculation on why the FDA is reluctant to take on things like this.

Addition, June 11: Here is Melanie Warner’s take on this on her BNet Food Industry blog site (she quotes my post).

I’ve been collecting items sent to me this week about government actions at the local, state, and national level.  Here’s the weekend round up.

Santa Clara County, California, Board of Supervisors bans toys in kids meals: On April 27, the San Jose Mercury News announced that this county, clearly at the vanguard of actions to help prevent childhood obesity, passed a groundbreaking law banning toys in kids’ meals that do not meet minimal nutrition standards (the very ones I talked about in a previous post).  Companies can still give out toys in meals, as long as the meals meet those standards.  What an excellent idea.  Let’s hope this idea catches on in other communities.

Here’s the press release, a a fact sheet on childhood obesity, and remarks by the president of the board of supervisors, along with recommendations from the local public health agency.  Thanks to Michele Simon for the documents.

Connecticut state legislature plays computer games: This photo, attributed to the Associated Press, arrived from Michelle Futrell.  I worried that it might be Photoshopped.  Whether it is or not, it is flying around the Internet, in versions that clearly identify each of hard-at-play legislators.

The Federal Trade Commission (FTC) teaches kids about marketing: The FTC regulates advertising, including food advertising, and it must be getting increasingly concerned about the effects of marketing on kids.  To counter some of these effects, it has created a website, Admongo.gov, an interactive site to teach kids about advertising.  After playing these games, the FTC wants kids to be able to answer these questions:

• Who is responsible for the ad?
• What is the ad actually saying?
• What does the ad want me to do?

The New York Times concludes: “Perhaps the effort comes not a moment too soon. Adweek devotes this week’s issue to “Kids” and “How the industry is striving to conquer this coveted market.” Thanks to Lisa Young for sending the links.

The FDA asks for comments on front-of-package (FOP) labeling: Patricia Kuntze, a consumer affairs advisor at the FDA sends the April 28 press release and the April 29 Federal Register notice announcing the FDA’s call for public comment on this topic.  The agency particularly wants data on:

• The extent to which consumers notice, use, and understand FOP nutrition symbols or shelf tags
• Results of research examining the effectiveness of various FOP approaches
• Graphic design, marketing, and advertising that will help consumers understand nutrition information
• The extent to which FOP labeling influences food manufacturers’ decisions about the contents of their products

The goal, says the FDA, is to make “calorie and nutrition information available to consumers in ways that will help them choose foods for more healthful diets – an effort that has taken on special importance, given the prevalence of obesity and diet-related diseases in the U.S. and of increasingly busy lifestyles that demand quick, nutritious food.”

Here is a speech on the topic by FDA Commissioner Margaret A. Hamburg, M.D.  For information about how to submit comments, click here. To submit comments, refer to docket FDA-2010-N-0210 and click here. You have until July 28 to do it.

Public comment, of course, includes the food industry and a FoodNavigator call for industry comment cites my recent commentary in JAMA with David Ludwig.  I’m glad food industry people are reading it and I hope the FDA does too.

The White House equivocates on organics: What’s going on with the White House garden?  Is it organic or not?   Michael Pollan forwards this item from the Associated Press:

Assistant White House Chef Sam Kass, an old friend of President Barack Obama’s who oversees the garden, says labeling the crops “organic” isn’t the point, even though the White House only uses natural, not synthetic, fertilizers and pesticides.

“To come out and say (organic) is the one and only way, which is how this would be interpreted, doesn’t make any sense,” Kass said Monday as he walked among the garden’s newly planted broccoli, rhubarb, carrots and spinach. “This is not about getting into all that. This is about kids.”

Uh oh.  Has “Organic” become the new O-word?  Surely, the White House is not secretly pouring herbicides and pesticides over its garden vegetables.  If not, are we hearing a small indication of big agribusiness pushback?

Really, you can’t make this stuff up.  KFC has a new promotion with Susan G. Komen for the Cure, the group that raises funds to fight breast cancer.  The campaign is called “Buckets for the Cure.”

Participating KFC franchise locations will be selling specially designed pink buckets of grilled and Original Recipe chicken. KFC has pledged 50 cents to Komen for every pink bucket ordered by its restaurant operators during the promotion period, with a minimum donation of $1 million and a goal to raise more than $8 million. Twenty-five percent of the funds raised will be earmarked to Komen’s 120-plus domestic Affiliates for breast cancer programs in their communities. The remainder of the funds will support Komen’s national research and community programs.

OK, scientists are still arguing about the dietary determinants of breast cancer and aren’t too worried about fat, but they do worry about body weight.  Maintaining a healthy body weight is still the first recommendation of the American Cancer Society, for example.  Isn’t this campaign an incentive to buy as many buckets of KFC as you can?

On the topic of KFC’s pink buckets: the Dogwood Alliance is collecting signatures on a petition to stop KFC from destroying forests to make them in any color.

KFC buys from International Paper, a company notorious for “business as usual” destructive forest management practices like large-scale clearcutting, conversion of natural forests to plantations and reliance on toxic chemicals in forest management.

Dogwood wants KFC to use more environmentally friendly packaging for its buckets.  It has collected more than 9,000 signatures so far.  Here’s where you can add yours.

Addition, May 1: Thanks to Michelle Simon for forwarding this clip from Colbert.  A must-see.  It starts after the worm story at 1:15.