Chinese Herbal Compounding and Safety Certificate of Qualification Course

The National Certification Commission for Acupuncture and Oriental Medicine (NCCAOM) offers an online course that provides best compounding and dispensing practices for licensed acupuncturists, herbalists, students, lab technicians, herb pharmacy compounders, and any other office staff who compound herbal formulas in their office or retail dispensaries. Participants receive 10 NCCAOM PDA points and the official NCCAOM CHCS COQ Badge on program completion.

Common Herb Allergies

Allergen Labeling and Consumer Protection Act 2004

Wheat – fu xiao mai, shen qu

Gluten – e jiao, fu xiao mai, lu jiao jiao, mai ya, shen qu, yi tang

Soy – dan dou chi, e jiao, he shou wu, lu jiao jiao

Tree Nuts – bai guo, hu tao ren, shen qu, xing ren, yu li ren

Others – sesame (zhi ma) and cuttlefish (hai piao xiao)

Herb-Drug Interactions – Chen X.W., Sneed K.B., Pan S.Y., Cao C., Kanwar J.R., Chew H., Zhou F. Herb-drug interactions and mechanistic and clinical considerations. Curr. Drug Metab. 2012;13:640–651. doi: 10.2174/1389200211209050640.

FDA on Botanical Drugs and Supplements – https://www.fda.gov/regulatory-information/search-fda-guidance-documents/complementary-and-alternative-medicine-products-and-their-regulation-food-and-drug-administration

Chinese Herbs & Allergens: Labeling with Caution

By Shellie Rosen, DOM, Lac – Published February 2018, Acupuncture Today

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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.

What are the Major 8 Allergens?

• Milk
• Egg
• Fish
• Crustacean shellfish
• Tree Nuts
• Wheat
• Peanuts
• Soybeans (or processed with soy)

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. 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.