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Last year food, beverage and drug labels were impacted by a variety of regulatory changes as various agencies worked to provide more and better information to consumers and health care professionals.

Over the past 12 months, the Food and Drug Administration (FDA) has used the full range of its enforcement tools to get the most "bang for the buck" in terms of protecting the public health.

In 2004, you saw updates to the Nutrition Facts box, newly approved health claims, the introduction of a voluntary Alcohol Facts box and a looming deadline for adding Drug Facts. Pop quiz: After all the see-sawing, what's the latest word on mandatory country-of-origin labeling?

Here's a concise review of major labeling law changes in 2004 that will affect you in 2005 and beyond.

Nutrition Facts overhaul

One of the biggest issues to influence food labeling in 2004 was the ongoing quest to curb obesity. Redefined by the Food and Drug Administration (FDA) as a national epidemic, rising obesity rates and mounting evidence linking obesity to conditions such as diabetes, heart disease and death prompted the agency to heighten its efforts to better educate the public on the basics of healthy nutrition. FDA acted to put the onus on food companies to be more specific with their nutrition labels.

Several recommendations came as a result of FDA's Obesity Working Group report, the final version of which was issued this past March. The Group's long- and short-term proposals are based on the scientific fact that weight control is mainly a function of caloric balance.

Two of the label-centric aspects of the findings involve stepping up enforcement actions concerning accuracy of food labels and enhancing the food label to display calorie count more prominently--and to use meaningful serving sizes.

An FDA official interviewed for this article comments on the latter finding, saying "One of the primary recommendations is for food and beverage manufacturers to take advantage of the flexibility within the current law, by labeling the caloric intake for a food that could be consumed in one sitting occasion as a single serving. For example, a 20-ounce carbonated beverage would contain 2.5, eight-ounce serving sizes. Rather than listing the nutritional data for each of the 2.5 servings, the beverage manufacturer could instead list the total caloric value for a single serving of 20 ounces."

The increased label reading sophistication of consumers has also prompted FDA to demand the disclosure of trans fat and saturated fat on all processed food labels. Although FDA's trans fat label ruling isn't scheduled to take effect until Jan. 1, 2006, several companies--Unilever Bestfoods and Tyson, among them--are already eliminating it from their goods and replacing it with more healthful oils to attract a wider array of health-focused consumers (see "Bestfoods, Tyson tout no trans fat on labels" from Food & Drug Packaging, April 2004).

The carbohydrate conundrum

Mid-way through 2004, news broke that the Low Carb diet movement had peaked. Although the popularity of Atkins and similar low-carb lifestyles has continued to wane, there continues to be a myriad of low carb products making their way to store shelves.

In March, FDA took steps to homogenize the verbiage used to describe a food or beverage's carbohydrate quantity. "The simplest, most direct phrase, 'low carb' for example is not allowed on food labels," explains Karen Duester, president of Food Consulting Co., a company that specializes in the preparation of regulation-compliant food label components for the food industry.

FDA regulations for nutrient content claims (21CFR101.13) permit labels to describe the level of certain nutrients in a product using the term low, but FDA has not established values for carbohydrate in relation to claims; therefore, the term "low" cannot be used in association with the term carbohydrate or "carb" on food labels.

Referring to the FDA regulations, Duester says the terms "free," "zero," "no," "without," "trivial source of," "negligible source of," "dietarily insignificant source of," "low," "little," "few," "contains a small amount of," "low source of," "reduced," "less," "lower," "fewer," and any synonyms of these words are disallowed to describe carbohydrate content on food labels. However, food labelers may make an accurate quantitative statement of fact (such as, 5g carbohydrate per serving), as long as the statement does not characterize the amount of carbohydrate present. A statement such as "only 5g carbs" for example, is not allowed since the word "only" characterizes the level of carbohydrate as low.

Duester further explained that FDA regulations do not disallow the terms "net carbs," "net impact carbs" or "net effective carbs" to describe carbohydrate content on food labels. These terms are being used by the food industry to reflect the amount of carbohydrate a product contains that will impact blood glucose levels. The value is derived from the formula, net carbs = total carbohydrates - dietary fiber - sugar alcohols.

It was reported that FDA's Center for Food Safety and Applied Nutrition (CFSAN) planned to begin rulemaking to define the terms "low," "reduced" and "free" with respect to carbohydrates by the end of last year. In related news, the American Association of Cereal Chemists (AACC) announced on Oct. 25, 2004, that the organization is working to develop a science-based, measurable definition of glycemic carbohydrates. Also, Atkins has reported that the company developed a clinical method that measures the actual glycemic impact of specific products and the company will soon be using the term "Net Atkins Count[TM]" in place of the previously used "net carbs."

From what country?

In other food labeling news, the country-of-origin labeling (COOL) portion of the 2002 Farm Bill was initially to have gone into effect this past fall. However, it hit its first snag on Jan. 27, 2004, when President Bush signed Public Law 108-199 delaying implementation of mandatory COOL for all covered commodities (except wild and farm-raised fish and shellfish) until Sept. 30, 2006. As published in October 2004 in the interim final rule, fish and shellfish must indicate country of origin on labels by April 2005.

This past December, an amendment that would have repealed the law was successfully removed by COOL proponents from the interim final rule.

COOL has been a veritable tug of war between supporters of the labeling requirement and food processors who opposed the cost of the requirement, which, according to estimates from the U.S. Department of Agriculture could range from hundreds of millions to billions of dollars solely in the first year.

The issue of origin labeling is far from over. It's not know what actions, if any, the 109th Congress will take on this issue in 2005. However, many in the industry say they are still open to considering voluntary labeling with voluntary standards akin to those used by organic foods. Further information on this plan was not available at press time.

New food label health claims

The conventional food labeling landscape was forever changed in 2004 thanks to a trio of FDA-approved health claims:

* In March, FDA announced its first qualified food label claim for use on packages of whole and chopped walnuts that makes the connection between walnut consumption and the reduced risk of coronary heart disease (CHD).

* In September, FDA announced the availability of a qualified health claim for reduced risk of CHD on conventional foods that contain eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) omega-3 fatty acids.

* In November, FDA announced the availability of a qualified health claim for monounsaturated fat from olive oil and reduced risk of CHD.

Food allergen awareness

As reported in the September 2004 issue of Food & Drug Packaging, the Food Allergen Labeling and Consumer protection Act of 2004 was passed to protect millions of U.S. consumers who suffer from food allergies. The new law requires a product be clearly labeled if it in any way contains any of the following eight food allergens: milk, egg, fish, shellfish, tree nuts, wheat, peanuts and soybeans. The new labeling requirements apply to any food that is labeled on or after Jan. 1, 2006.

GM foods face global opposition

In the last five years, genetically modified (GM) foods have become one of the hottest topics in the world food arena. While the U.S. market has generally embraced bioengineered foods, the global marketplace has voiced an overwhelming opposition to them. As of Dec. 3, 2004, 111 countries have ratified the Cartagena Protocol on Biosafety, a global contract designed to address the liability for, the labeling of and the information-sharing related to the international shipping of GM organisms. The U.S. is not currently counted among the 111 countries currently in favor of the Protocol.

For more information on the details of and the developments related to the Protocol, log on to the Convention on Biological Diversity's website at www.biodiv.org.

Soft drink ingredient statement

In the realm of beverage labels, the soft drink industry suffered a labeling setback in November when FDA withdrew the industry's 1993 special exemption request to use "and/or" with regard to sweetener labeling and identification. Soft drinks are sweetened almost exclusively with high fructose corn syrup, yet soft drink manufacturers list "high fructose corn syrup and/or sucrose," in ingredient statements despite the fact that sugar has not been used in major soft drinks since the mid-1980s.

Alcohol Facts label limbo

In December 2003, two consumer 2interest groups--the National Consumers League and the Center for Science in the Public Interest--spearheaded a collective petition to the Alcohol and Tobacco Tax and Trade Bureau (TTB) proposing a uniform Alcohol Facts label. The petition urged the agency to consider a new "Facts" label for alcoholic beverages that would deliver clear information about alcohol content, serving sizes, calories and ingredients.

While the comment period for the proposed label closed in August, the planned ruling will permit manufacturers to voluntarily label their products with a Serving Facts panel. Should manufacturers decide to implement the label, it is required to list facts such as serving size, servings per container, calories, grams of fat, grams of carbohydrates, grams of protein and ounces of alcohol to the nearest tenth of an ounce. The label must also include the following statement: "A standard drink contains 0.6 fl. oz. of alcohol. A serving of this beverage is XX standard drink(s)" or "... XX of a standard drink."

While the fate and future tooling of the Alcohol Facts label remain to be seen, such a label would certainly be welcomed by today's label-oriented consumer.

What's in your bottled water?

Bottled water is regulated on federal state and trade levels. FDA regulates bottled water as a food product and as such, bottled water companies must adhere to the FDA's Quality Standards, Standards of Identity (Labeling Regulations) and Good Manufacturing Practices.

And as of April 2004, water companies must also label their waters to define where the water came from and if it's been purified or carbonated. Bottled water can be classified as one of the following: artesian water/artesian well water, drinking water, purified water, mineral water, spring water, sparkling water, carbonated water, flavored water, waters with healthful additives, distilled water or tap water.

For a complete listing of the definitions for each of the aforementioned classifications, log on to the Department of Health's website at www.doh.gov.za /docs/regulations/2004/reg0502.html.

Rx and OTC developments

Late in 2004, mounting health concerns prompted FDA to more closely scrutinize widely used prescription (Rx) drugs. While some popular drugs were completely pulled from the shelves, others have undergone substantial label retooling to better inform the public about the possible health risks or side effects that could occur with consumption.

For example, in December the label on Pfizer's arthritis drug Bextra was amended to include a warning about possible heart and blood-clotting problems. Bextra is a COX-2 inhibitor, similar to Merck's arthritis drug Vioxx, which was pulled it off the market in September because of safety concerns that linked the drug to increased risk of heart attack and stroke. Bextra's new label now features a bold-faced warning against using it after coronary artery bypass surgery, and also notes that studies in arthritis patients have conclusively detected an increased risk of cardiovascular problems. The new label also features a "black box" warning about "rare, serious" skin reactions.

Over-the-counter (OTC) drug manufacturers are preparing for the upcoming May 16, 2005 deadline on which all OTC drug labels must include FDA's new standardized Drug Facts panel. This rule primarily focuses on drug products; however, FDA also considers cosmetic products that make claims to physiologically alter the body's structure (that is, "removes fine lines") to be OTC drugs. Therefore, the packaging for such cosmetics products must include the Drug Facts panel.

The new consumer-friendly Drug Facts label is patterned after the Nutrition Facts food label. It's standardized, easy-to read format allows consumers to better compare OTC medicines and follow dosage instructions. It also uses plain-speaking terms to describe the facts about each OTC drug. For example, "uses" replaces "indications," and other technical words like "precautions" and "contraindications" have been eliminated. The new label also requires a type size large enough to be easily read and specific layout details-bullets, spacing between lines and clearly marked sections-to improve readability.

FDA recently developed a new draft compliance guide for small businesses entitled "Labeling OTC Human Drug Products; Small Entity Compliance Guide." The draft guidance is intended to help small businesses better understand the requirements of the Drug Facts labeling rule and to prepare new labeling within the compliance dates. Comments on the draft are due by Feb. 7, 2005.

HUD packs need bar codes

In the Feb. 26 Federal Register, FDA announced its intent to issue a new rule requiring certain human drug and biological product labels for hospital unit-dose (HUD) packs to have bar codes. The bar code for human drug products and biological products (other than blood, blood components and devices regulated by the Center for Biologics Evaluation and Research) must contain the National Drug Code (NDC) number in a linear bar code.

The rule, which went into effect on April 26, 2004, was designed to help reduce the number of medication errors in hospitals and other health care settings by allowing health care professionals to use bar code scanning equipment to verify that the right drug (in the right dose and right route of administration) is being given to the right patient at the right time. The rule also requires the use of machine-readable information on blood and blood component container labels to help reduce medication errors.

Drug products that receive approval on or after the rule's effective date must comply with the bar code requirement within 60 days after the drug's approval date. Drug products that received approval before the final rule's effective date must comply with the bar code requirement within 2 years after the final rule's effective date. For complete information on this rule, log onto www.fda.gov/cber/rules/ barcodelabel.htm.

Dietary supplement developments

For the most part, it's been relatively quiet on the nutraceutical front. The ephedra ban is a thing of the past; however, that hasn't stopped the FDA from cracking down on dietary supplements carrying fraudulent weight loss claims.

On Oct. 22, 2004 FDA sent eight warning letters to dietary supplement distributors making unsubstantiated claims for dietary supplement products promoted for weight loss over the Internet. Since those claims lacked adequate substantiation, they are considered false or misleading; therefore, the products are misbranded. FDA will continue to work with the Federal Trade Commission to target dietary supplements making false or misleading weight loss claims. FDA is even exploring the concept of third party certification of weight loss diet plans and related products.

On Nov. 4, 2004, FDA also sent a letter to major retailers of dietary supplements to inform them that products labeled with unsubstantiated claims are mis-branded and that FDA may take enforcement action against mis-branded products in their possession. FDA intends to start a program of inspections of retail establishments to identify products bearing unsubstantiated claims in their labeling.

Label regulations spanning the categories of food, beverages and drugs have come a long way in a short time. Yet there is still room for further fine tuning. Some companies and industry organizations are lobbying for some harmonization with global labeling laws, especially with the European Union. Don't expect anything to be resolved any time soon, though. But it is heartening that initial conversations have started.

Food & Drug Packaging will continue to keep you abreast of breaking label news in the coming year.

Joanna Cosgrove, a freelance writer based in Media, Pa., has been writing about various aspects of packaging, product design and product manufacturing since 1996.

Her e-mail address is joannacosgrove@comcast.net.

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