The growing prevalence and awareness of allergen-related side effects from consumable goods begs the question, “Are we labeling potential allergens appropriately?” The Food and Drug Administration (FDA) has required allergen labeling for over a decade. The ingredients the FDA focuses upon are responsible for “90 percent of all food allergies.”1 Chinese herb formulas may contain potential allergens not typically recognizable to consumers and not currently required by the FDA. Practitioners can provide an excellent service to patients by understanding the food allergen labeling law, the ingredients necessary to label, and additional Chinese herbs that are worth discussing (and labeling) with sensitive patients.
The Allergen Labeling Law
The Food Allergen Labeling and Consumer Protection Act (FALCPA) became law in 2004 (Title II of Public Law 108-282). The purpose of FALCPA was to set requirements for supplements or foods that contain a major food allergen, or proteins associated with allergens, to be appropriately labeled for consumers.
Section 403 of the Federal Food, Drug and Cosmetic Act from 1938 requires that food “fabricated from two or more ingredients declare each ingredient by its common or usual name.” FALCPA was needed to assist consumers of food and supplement products further because allergens became both more prevalent and widely known as causes of illness. Consumers required help identifying potential antagonists. Some labels under section 403 were initially not clear enough for those suffering from allergen sensitivities.1 What are the major 8 allergens?
Chinese medicine practitioners must ensure their prescriptions carry allergen labels for the ‘major eight’ allergens. The agency released a “Final Guidance” October 5, 2005 that breaks down specific areas required for labeling allergens. For example, if a product contains tree nuts or fish, the particular type of nut and fish/shellfish must be labeled. The deadline for dietary supplements to comply with allergen labeling requirements was January 1, 2006.1 Chinese Herb practitioners serve patients best when they contract with companies that label allergens in compliance with federal regulations.
What You Should Label
Label any ingredient that derives from a potential allergen, since labeling products is a public safety concern, especially in the case of potential allergens. FALCPA wants consumers to have access to clear language that avoids ambiguity. Labels are not compliant when they do not state the source product of the allergen. Listing “whey” isn’t adequate; the label must also say “milk.”
A product that derives from a potential allergen must label that allergen source. Perhaps there is a belief that a particular processing method may mitigate the potential threat of an allergic response. In this case, opinions shall not interfere with patient rights. For example, some individuals may be allergic to shrimp, but tolerate glucosamine made from shrimp. Perhaps because glucosamine derives from shrimp shells, not shrimp flesh where the protein that initiates an allergic response resides. Although allergic reactions have not been problematic with shell-derived glucosamine, it is sourced from shellfish and must label as such.
Patient’s and their doctors have the right to know what products are in their prescription. If you have done research on a particular processing method and you believe potential antagonists transform enough to render the allergen source inactive, then offer your patient the information and allow them to decide with their doctor if the risk is worth it. The Chinese herbal compendium offers creative ways around potential allergens, why take a chance?
If you want to get an idea of what a safety recall by the FDA looks like, check out their website. Notice how many products you find recalled for “Undeclared” ingredients related to potential allergens.3
Gluten is the ingredient my patients ask about most. The FDA only requires labeling for “wheat,” not gluten. There is an entirely different required level of compliance for products that state “Gluten Free,” so please do not include that into your labeling practice without investigating those guidelines. Some product lines wisely list gluten as a known ingredient. Subhuti Dharmananda writes a detailed article regarding the presence of gluten in Chinese herbs entitled, Gluten in Chinese Herbs: Addressing the Concerns of Those with Celiac Sprue. He points out three commonly used herbs with gluten, in three popular formulas.4
What Do Allergic Responses Look Like?
In many cases, an allergic response will happen within two-hours of ingestion (or application) of an herb. Symptoms can range from a mild rash to severe anaphylaxis a potentially life-threatening reaction requiring emergency medical attention. Visit the Food Allergy Research & Education website to learn of symptoms so you can educate your patients ([url=http://www.foodallergy.org/life-with-food-allergies/food-allergy-101/symptoms-of-an-allergic-reaction-to-food]http://www.foodallergy.org/life-with-food-allergies/food-allergy-101/symptoms-of-an-allergic-reaction-to-food[/url]).5 If using surface releasing herbs, make sure to inform your patient of the potential for itching or rash, so they do not confuse this intended side effect with an allergic reaction.
More Potential Allergens
The example of FALCPA’s requirement for the labeling of “wheat” not “gluten” points to the chasm between what is required labeling by the FDA and the product knowledge of experts in the field dealing with patients. As a licensed Chinese herb practitioner, it is wise to consider an expanded list of potential allergens that might negatively affect your patients. Review this list of commonly used Chinese herbs with potential allergens, to be mindful when formulating for a patient, or monitoring unexpected side effects. Gluten:
Latex (mild to severe allergic response, including anaphylaxis (a life-threatening shock reaction). (See Bob Flaws explanation on latex sensitivities in a previous issue of Acupuncture Today: (May 2002):6
Animal & Insect
Volatile Oils
Ragweed (herbs in the asteraceae [daisy] family):
Nightshades
Seeds
Mushrooms
Common Chinese Herbs That Must be Labeled(According to FDA Law)
Crustacean Shellfish & Mollusks
Wheat
Tree Nuts
Soy (potentially processed with soya-bean oil*)
Cross Contamination
Cross contamination is important when preventing allergic reactions in sensitive patients. If you compound herbs and don’t use current Good Manufacturing Practices (cGMP) designed to remove particles from previously prepared formulas, or herbs, you might consider outsourcing in certain cases.8 Not all potential allergens are listed in this summary. If you have a patient that is known to have extreme allergen sensitivities please do your homework! Use information wisely. Allergen warnings are not meant to create unnecessary concern. Chinese herb formula labels are complicated for patients.
Labeling topical Chinese herbs is also essential, since allergic contact dermatitis may occur. Even if you or your manufacturer do label an ingredient like Mo Yao (Myrrh), or Huang Chu Ju (Chamomile), the patient might not know if they are allergic since they may be unfamiliar with Chinese herbs. For this reason, you might recommend patients test topical medicines on a small portion of skin before exposing larger areas as good practice.
State-licensed Chinese medicine practitioners can help educate patients to prevent and understand unexpected side effects of potential allergens. Chinese herbal medicines offer plenty of options when it comes to designing the right formula for the patient. Pre-made supplements often don’t have this luxury.
Offer products in compliance with FDA labeling laws and take patient safety a step further with additional wisdom about ingredients such as gluten or latex. Confidently speak about potential allergens in your practice and with your suppliers. Practitioners are advocates for patient rights when it comes to product transparency.
If you are curious about whether or not the products you prescribe to your patients are under FALCPA requirements, visit:1 https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Allergens/default.htm.
References
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