Redefining “Healthy” Sodium Levels

On Sept. 29, 2005, FDA amended its regulation concerning the maximum sodium levels permitted in foods that can carry the nutrient-content claim “healthy.” The agency decided to retain the currently effective, less-restrictive, “first-tier” sodium-level requirements for all food categories, including individual foods (480 mg per serving) and meals and main dishes (600 mg per serving), and is eliminating the more-restrictive “second-tier” sodium-level requirements for all food categories (360 mg sodium per serving in individual foods and 480 mg sodium per serving for meals and main dishes).

The initial ruling was implemented on May 10, 1994 and defined criteria for use of the nutrient-content claim “healthy” and its derivatives (i.e., “health” and “healthful”) on individual foods, including raw, single-ingredient seafood and game meat, and on processed meal and main-dish products. It also established two separate criteria for sodium content in foods bearing a “healthy” claim.

The intent of the two-tiered sodium- level requirements was to encourage industry innovation and to further reduce sodium levels in foods bearing the term “healthy.” However, since this regulation, food manufacturers have urged FDA to eliminate the more-restrictive second- tier sodium requirements until food technology catches up with FDA’s goal of reducing the sodium content in foods. This rule has made it difficult for food manufacturers to develop new products and threatened existing “healthy” products because of stricter nutrient requirements and lack of demand. Over the past decade, manufacturers have found it difficult to find suitable alternatives for sodium and the lack of consumer acceptance of certain “healthy” products made with salt substitutes and/or lower sodium, due to undesirable flavor profiles, which often led to poor sales of products that met the second-tier sodium level requirements.

Manufacturers also faced reformulating and marketing costs to keep the “healthy” claim on an existing product. Because the health claim was so restrictive and reformulation costs so high, some manufacturers chose to rebrand or relabel their products out of the “healthy” category, which meant they were not subject to any sodium limit. For example, the Campbell Soup Company, Camden, NJ, makes structure/function claims for its soup and juice products that contain more sodium than that required amount to evade an FDA-approved sodium health claim.

For this reason, FDA reevaluated its position on this rule and realized that enforcing the second-tier sodium level requirements for the “healthy’’ claim by Jan. 1, 2006 might, in fact, result in a smaller selection of nutritionally desirable foods on the market. Having more-restrictive sodium levels inhibits the development of new “healthy” food products in the marketplace due to the lack of technology and sodium alternatives. By retaining the higher first-tier sodium level requirements for all food products bearing the term “healthy,” FDA hopes to encourage manufacturers to continue making healthy products consistent with dietary guidelines.

Even though FDA has amended its original ruling, “we think it ought to be eliminated entirely. There is no scientific evidence that a reduced-sodium diet is beneficial in health outcomes,” says Richard L. Hanneman, president, Salt Institute, Alexandria, VA. “We’re hopeful to see the FDA drop its requirement for sodium entirely.”

But Michael F. Jacobson, executive director, Center for Science in the Public Interest, Washington, D.C., is concerned by this news because sodium levels in food already “range from high to extremely high.” With FDA removing the more-restrictive second-tier sodium requirement, “it is virtually impossible for people to follow health authorities’ advice to cut way back on sodium,” especially when packaged and restaurant foods make up such a big part of Americans’ diets, he adds. He further comments that this ruling does not encourage food companies to use less salt, especially in products that have the highest sodium levels.

Furthermore, FDA has revised the term “healthy” as an implied nutrient content claim. The agency decided to redefine the regulatory text for the definition of “healthy” to clarify the term and the nutrient-content requirements for “healthy” so more consumers and manufacturers can understand the scope and meaning of the regulation and the requirements for using the “healthy” claim in food labeling.

Robert Earl, M.P.H., R.D., senior director of nutrition policy, the Food Products Association (FPA), recently responded to news of USDA’s launch of a food-guide pyramid for children, called MyPyramid for Kids: “Beginning nutrition education in early childhood is an important part of helping to ensure that children will achieve healthful lifestyles. MyPyramid for Kids will help facilitate this early education by providing teachers with valuable instructional aids. MyPyramid for Kids and USDA’s interactive website will help children learn about how to make food choices, as well as emphasizing the importance of physical activity and that, most of all, both eating and physical activity should be fun.”

Eating dark chocolate might have a protective effect on the cardiovascular system in healthy people, suggests Dr. Charalambos Vlachopoulos, Athens Medical School, Greece. He and his colleagues published the results of their study in the June 2005 issue of the American Journal of Hypertension after examining the effects of flavonoid-rich dark chocolate on blood-vessel function in healthy individuals.

The researchers found that arteries dilated significantly more in response to chocolate consumption, which increases the body’s blood flow. In addition, it led to a 7% decrease in aortic stiffness.

FDA has issued a qualified health claim on tomatoes and tomato sauces indicating that 12 to 1 cup of tomatoes or tomato sauce weekly might be beneficial in reducing the risk of prostate cancer. A key piece of research submitted for FDA review as part of the petitioning process was a placebo-controlled, double-blind human clinical trial conducted using LycoRed Natural Products Industries, Ltd., Be’er Sheva, Israel, Lyc-O-Mato® ingredient — an all-natural whole-tomato extract that provides lycopene and phytonutrients, which research suggests is responsible for reducing the risk of prostate cancer.

Research demonstrating the positive health benefits of probiotics was presented at IDF’s International Symposium on “Understanding the Role of Probiotics in Health” in Gent, Belgium. The scientific studies revealed new evidence that probiotics play a major role in: reduction of constipation and several types of diarrhea, decrease of urinary- tract infections, alleviation of abdominal pain in irritable bowel syndrome patients, effective treatment of pouchitis, and reduction of the occurrence of inflammatory symptoms. The positive influence of probiotics on the immune system, including reduction of the risk of colon cancer, is a main focus of current research.

As of Jan. 1, Lonza Group, Basel, Switzerland, announced a worldwide price increase of 10% to 12% for niacin and niacinamide due to continued price increases of raw materials, energy and transportation. Other companies also raising prices for the same reasons include: International Specialty Products, Wayne, NJ, with a 7% increase on all alginate-based products worldwide; The Solae Company, St. Louis, with a 5% to 15% increase for Solect™ lecithin;

National Starch Food Innovation, Bridgewater, NJ, with a 8% to 10% increase on its food and pharmaceutical starches; FMC BioPolymer, Philadelphia, with a 5% to 10% increase for food and pharmaceutical brand products; and Huber Engineered Materials, Atlanta, with a 10% increase on its Hubercal® calcium carbonate.

Monsanto Company, St. Louis, announced that Cargill, Inc., Minneapolis, will be a participating processor of Monsanto’s Vistive™ low-linolenic soybeans in 2006 and will continue to market the oil for the food industry. Low-linolenic soybeans reduce the need for partial hydrogenation of soybean oil, helping companies reduce the presence of trans fats in products.

Blue Mountain Flavors, Kinston, SC, specializing in authentic meat and meat-like flavors, has recently received halal certification from the Islamic Food and Nutrition Council of America, Chicago.

Roquette America, Keokuk, IA, announced it’s increasing prices for all non-contracted specialty products due to significant increases in energy, chemicals, packaging and other key cost inputs. This price increase became effective Dec. 1, 2005. All shipments will remain subject to the company’s fuel-surcharge program.

A new study from Leatherhead Food International, Surrey, England, has shown that Raftilose®, a prebiotic ingredient from Belgium-based Orafti Group, can lower the glycemic index of food products when replacing sugar. The study measured glucose levels over a two-hour period after 12 volunteers ate ice cream containing 15% Raftilose, and then traditional ice cream. The prebiotic ice cream gave a glycemic response 70% lower than after eating the traditional ice cream.

Howard R. Moskowitz, Ph.D., received the 2005 Charles Coolidge Parlin Marketing Research Award at the annual conference of the American Marketing Association in Boston for substantial contributions and dedication to the ongoing advancement of marketing research. This is the oldest and most-distinguished award in the field recognizing academics and practitioners who have demonstrated outstanding leadership and sustained impact on advancing the evolving profession of marketing research over an extended period of time.

Loders Croklaan, Wormerveer, Netherlands, announced the expansion of its oil-processing factory in Channahon, IL. The 10,000-sq.-ft. expansion of the company’s existing Channahon facility doubles throughput, increases storage capability by 200% and further enhances the production of palm-based products. The new facility also incorporates a state-of-the-art bleaching line that boosts capacity by 400%. In addition, a new oil in-line blending capability increases bulk capacity by 100%.