Allergies have been observed since the early Greeks and Romans; Hippocrates even documented milk sensitivity. The term "allergy" is used to describe the reaction to a food ingredient that causes a sensitivity response in a person when consumed. While any food protein can trigger an allergic response, and allergic reactions to a large number of foods have been documented, only a small group of foods actually account for most of these reactions. In fact, 90 percent of allergic reactions can be attributed to eight major foods/food groups: milk, eggs, fish, Crustacean shellfish, tree nuts, peanuts, wheat or soybeans

Adverse reactions to foods have been reported in up to 25 percent of the population at some point in their lives, with the highest prevalence observed during infancy and early childhood. Only about 2.5 percent of adults and about 6 percent to 8 percent of children (under 6 years of age) have true food allergy (also referred to as hypersensitivity reaction), which is estimated to affect about 4 million individuals in the United States each year. The rest have what is known as food intolerancean undesirable reaction to a food that does not involve the immune system.

In the case of food allergies, the reaction is immunologically-related, when the bodys immune system mistakes an ingredient in food, usually a food protein (an amino acid sequence), as being harmful substance (such as a virus, bacterium or another antigen). The molecular weight of most known allergens is between 10,000 and 40,000 daltons. Sensitive individuals can develop a range of symptoms that can be mild or life-threatening if exposed to a causative allergen. After ingestion, the timing of the allergenic response can occur either immediately or be delayed up to several hours. Usually, symptoms are not serious, and may include rash or hives, gastrointestinal (GI) distress, itchy eyes or skin, shortness of breath, chest pain, headache, or swelling of the lips, tongue or face. A small percentage of food-allergic individuals experience severe reactions, called anaphylaxis. Anaphylactic shock is a relatively rare, but severe and potentially life threatening, allergic reaction resulting in swelling of the throat and air passage constrictions. Symptoms usually appear within minutes of exposure to the allergen and immediate medical attention is necessary. Each year, roughly 30,000 individuals require emergency room treatment, and 150 individuals die because of allergic reactions to food. There is no known cure for food allergies, and they are best managed by avoiding foods containing the known allergens. People who have allergic reactions to inhaled substances, such as dust, mold or pollen, are more likely to develop food allergies.

Food intolerance is not an immune system response, but is a digestive system response. Food intolerance occurs when something in a food causes an irritation in a person's digestive system or when a person is unable to properly digest or break down food components. Common examples are: intolerance to lactose, (found in milk and dairy products), or in a case of food poisoning from a food-borne pathogen. Symptoms of food intolerance can include GI distress, gas or bloating, vomiting, heartburn, headaches and nervousness.

The Production Impact

On Jan. 1, 2006, the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) became effective. FALCPA was signed into law by President George W. Bush on Aug. 2, 2004. This law requires manufacturers to clearly identify on labels of foodsand dietary supplementsif a product has any ingredients that contain protein derived from any of the eight major allergenic foods and food groups. FALCPA also requires the type of tree nut (e.g., almonds, pecans, walnuts), the type of fish (e.g., bass, flounder, cod) and the type of Crustacean shellfish (e.g., crab, lobster, shrimp) to be declared. Other allergenic foods (e.g., sesame) are not required to be declared in accordance with FALCPA. A food product may be subject to recall if it contains a major food allergen as an ingredient that is not declared on the food label in accordance with FALCPA requirements.

Cross-contamination in the dietary manufacturing facility is possible. Even a small trace amount of some allergens (e.g., peanuts) can result in a response. It is important for the facility to have cleaning procedures that remove or separate any allergic contaminates when producing different dietary products.

FALCPA further requires food/supplement manufacturers declare on the label if a product contains an ingredient that is one of the eight major allergens or that contains protein from a major food allergen in one of the following ways:

The labeling of ingredients by "common and usual names" as required by the Code of Federal Regulations has presented problems for allergic consumers. The typical consumer may not know caseinate, lactoglobulins and lactoalbumins are milk proteins or that semolina is wheat flour. Always use the common or usual name unless there is a regulation that provides for a different term.

Exemptions, Petition, and Notification

The Act contains exceptions to the labeling requirement. Highly refined oils, and ingredients derived from those oils, are specifically exempt from the definition of major food allergen. This is based on research indicating protein is not detectable in highly refined oil. The term "highly refined oils" is not defined in the act. But FALCPA does note that "highly refined oils" are those that are refined, bleached or deodorized, and do not contain any allergenic proteins. Cold-pressed oils may contain allergenic proteins, so be aware any oil touted as "highly refined" is actually is free of major allergen proteins.

Petitioning FDA is also a way to avoid allergen labeling. Petitions must include scientific evidence that a food ingredient does not cause an allergic response that poses a risk to human health. FDA has 180 days to approve or deny the petition. After 180 days, the petition is deemed denied unless FDA has acted to approve it or to provide an extension for considering the petition.

The Act also contains a notification procedure. This provision allows a manufacturer to provide scientific evidence that the food ingredient does not contain allergic protein; or a determination by FDA that the ingredient does not cause an allergic response that poses a risk to human health. This provision was included so that current efforts to establish threshold levels could be acknowledged in the future by FDA.

FDA regulations authorize the use of the term "non-dairy," and this terminology will continue to appear on foods that contain caseinates as ingredients. The caseinates must be listed in the ingredient section followed by a parenthesis and "milk." However, FDA does not specifically address the term "dairy-free," so that was not affected by FALCPA. Using the term "no-dairy" means that there are no dairy ingredients or compounds present in product.

Several categories of goods consumers use or ingest are not covered by FALCPA. These include:

Gluten-free Labeling

Accuracy of such labeling is very important, especially for those with celiac disease. Current research suggests for persons with celiac disease, the maximum safe level of gluten in a finished product is probably less than 0.02 percent (200 parts per million [ppm]) and possibly as little as 0.002 percent (20 parts per million). The level of 20 ppm is proposed based on the available analytic methods, since current analytic technology can reliably and consistently detect gluten in wheat, rye and barley to those levels.

FDA is proposing to define the term "gluten-free" for voluntary use in the labeling of foods. A definition for the term "gluten-free" established by FDA would assist those who have celiac disease (also known as celiac sprue or gluten-sensitive enteropathy) and their caregivers to more easily identify packaged foods that are safe for persons with celiac disease to eat. This proposed action is in response to FALCPA, which required FDA to issue a proposed rule to define and permit the voluntary use of the term "gluten-free" on labeling of foods by August 2006 and a final rule to be issued no later than August 2008. This has not yet happened; a proposed rule (issued Jan. 23, 2007) is pending and awaiting final approval.

According to the proposed rule, a "gluten-free" label would mean that a food does not contain any of the following:

The FDA proposed rule defines "prohibited grain" as any of the following: wheat, meaning any species belonging to the genus Triticum; rye, meaning any species belonging to the genus Secale; barley, meaning any species belonging to the genus Hordeum; and crossbred hybrids of wheat, rye or barley.

Robin Koon,  senior vice-president at Best Formulations has more than 25 years of pharmaceutical experience in clinical pharmacy and as a drug chain executive overseeing operations and managed care, and in retail mass market.