ALLERGENS IN SUPPLEMENTS
CAUSE FOR CONCERN FOR THE 15 MILLION AMERICANS WITH FOOD ALLERGIES
Consumers expect dietary supplements to be a safer, more convenient, and less expensive approach to health management with fewer risks of side effects and adverse reactions, and for the most part, their expectation is justified. However, because current Good Manufacturing Practices (cGMPs) recommended by the FDA only cover the bare minimum quality and safety standards that supplements must meet before they can be approved for sale, the potential for a supplement to produce an unexpected reaction or an undesirable side effect, as in the case of allergens, is still high. At NutriGold we recognize that dietary supplements - like those from foods - can produce allergic reactions either because they contain ingredients derived from high-risk allergenic foods (e.g. soy lecithin) or due to cross-contamination with high-allergen ingredients during manufacturing. This is the reason why, even though the FDA doesn’t require supplements to test for allergens or include allergen warnings on supplement labels, we test every lot of our raw materials and finished products for allergens. We aren’t kidding when we say, “we’ve got you covered.”
5 REASONS YOU SHOULD CARE ABOUT ALLERGENS IN SUPPLEMENTS
15 Million# of Americans with food allergies
8 Allergens# of allergens that account for over 90% of all allergic reactions
Every 3 MinutesFrequency of emergency room visits related to food allergies
Active IngredientsMany active ingredients are derived from allergenic raw materials like egg, fish, and soy
Most ExcipientsMost excipients are derived from allergenic ingredients like corn and soy
NutriGold's Allergen Testing & Labeling Initiative
According to the Food Allergen Labeling and Consumer Protection Act (FALCPA), allergen labeling requirements apply only to those foods regulated by the Food and Drug Administration under the Federal Food, Drug, & Cosmetics Act. In other words, manufacturers of dietary ingredients and supplements are NOT required to list allergens that may be present in the supplement nor provide any statutory warnings regarding the potential for allergic reactions from taking the supplement.
Given that approximately 50% of the US population takes one or more supplements AND ingredients derived from high-risk allergenic foods are routinely present either as an active ingredient or as an additive in dietary supplements, we perform a 6-step process to ensure that our finished products are safe for individuals with known or suspected food allergies.
At NutriGold, we care about allergens in supplements and test both our materials AND our finished products for allergens because we believe that "an ounce of prevention is better than a pound of cure."
|Step 1: Indentification and review of high-risk allergenic active and inactive ingredients||Step 4: Stringent compliance with cGMP standards to minimize cross-contamination from high-risk allergens during manufacturing|
|Step 2: Extensive verification of ingredient documentation to determine allergen risk status||Step 5: Voluntary, independent verification of finished products for corn, egg, gluten, milk, peanut, shellfish, and soy allergens|
|Step 3: Voluntary, independent testing of raw materials for corn, egg, gluten, milk, peanut, shellfish, and soy allergens||Step 6: Declaration of allergens (if any) and allergen warnings (if applicable) on product labels in the interest of complete transparency|