Accountability

Accountability can be broadly defined as “an obligation or willingness to accept responsibility or to account for one’s actions.” But, who exactly is it that we are accountable to? Ourselves? Others? If we are accountable to others, does it matter whether or not they have a commercial bias and stand to profit from our actions? And what about its value and impact? Does it matter whether the act of accountability is voluntary or required as a matter of policy or law? Although answers to these questions are a matter of opinion, we can all agree that accounting to others, especially when there is no requirement to do so, can help remove doubt and foster trust in a way that self-accountability simply cannot.

Within the nutraceutical industry, the majority of supplement companies have been operating for decades without feeling the need to account to anyone, including the FDA and FTC, for the quality of their products. While the FDA can take action against products and hold companies that make them accountable if they pose a threat to public harm, they do not routinely audit companies or test products to ascertain if they meet acceptable quality standards. Contrary to popular opinion, that degree of oversight is outside the scope of the FDA’s authority over the nutraceutical industry.

The FTC, on the other hand, does have the power to hold companies accountable and frequently does so, but only for potentially misleading claims about product features and benefits.

The quality of the products themselves is less relevant to the FTC’s goals than redressing consumer grievances about unethical or unlawful marketing practices. As for claims of compliance with good manufacturing practices (GMP) and seals boasting GMP certifications, it is worth noting that GMPs are about ensuring that companies have appropriate and sufficient processes in place to ensure that products meet quality standards, as defined by the FDA, NSF, or other industry watchdogs; they do not require validation of product quality by independent organizations.

In fact, there is currently no requirement within GMPs or any other regulatory guidelines to have products tested by an independent organization without commercial bias to show compliance with objective quality standards. This may be why few brands offer objective evidence that what’s on the label is actually inside the bottle. A GMP seal, at best, provides evidence that a process exists to ensure product quality and, at worst, simply confirms the existence of documents to that effect. It cannot and should not be taken as conclusive proof of a product’s authenticity, purity, or safety.

At NutriGold, we know that consumers make a conscious decision every single day to place their trust is us and the products we make that support their health. We consider this trust an invaluable gift and are committed to handling it with the care and respect it deserves. So, we surround ourselves with people who can hold us accountable for the choices we make and voluntarily work with third-party labs and independent certifying organizations with no commercial bias to validate those choices. It’s all part of our determination to make products that are safe enough to give to our families and yours.

According to current Good Manufacturing Practices (GMPs), manufacturers are responsible for ensuring that a finished product meets established specifications for identity, purity, strength (potency), and composition, using reliable and valid methods. However, GMPs provide no guidelines for what would be considered acceptable specifications for identity, purity, and potency, what methods would be appropriate to evaluate product compliance with quality specifications, or even how to to evaluate the “reliability” and “validity” of those methods. This provides manufacturers with considerable wiggle room when it comes to raw materials and finished products validation.

Manufacturers of dietary supplements differ in terms of what they test for, how often they test, who performs the testing, and what methods are used to ensure product compliance with label claims. They can choose to test every lot, every other lot, or random lots; they can test for some quality markers or all; they can use established, validated methods or internal methods; and they can test using in-house labs or independent, contract labs.

Neither the FDA nor the NSF or NPA differentiate between companies that perform just the bare minimum testing to demonstrate compliance and companies that perform extensive testing using independent labs with no commercial bias to ensure that products are safe for consumers. So, other than the intrinsic satisfaction of doing what’s in the consumers’ best interests, there is little or no incentive for companies to go above and beyond what is required by GMPS to test and validate products for authenticity, purity, and overall quality. And, for most companies, choosing to do what’s in the consumer’s best interests is a desirable ideal, but not always an achievable one, especially when it comes at the expense of profitability.

At NutriGold, our testing standards were developed to comply not just with the language of the GMPs, but with their spirit and intent as well. According to our testing standards, ingredients and finished products are tested for 100+ tests of identity, purity, strength (potency), and composition, even though GMPs only require a fraction of those to be mandatorily performed. Additionally, as part of our ongoing commitment to product quality and consumer safety, we test finished products every 3 months during the first 12 months following manufacturing and every 6 months thereafter until the best by date printed on the bottle to ensure ongoing compliance with label claims.

In addition to going above and beyond what is currently required by GMPs, the most defining aspect of our standards is that we voluntarily use only independent, third-party labs to perform all of the testing. We consciously and purposefully choose to work with contract labs because they have no vested interest in the test results and, therefore, no commercial bias. Working with third-party labs not only provides us with objective evidence of the quality of our ingredients and finished products, it also allows us to express our commitment to doing what’s in the consumers’ best interests, in the strongest way possible.

We all love to eat and enjoy good food. Who doesn’t? But, while we might have a love of good food in common, our bodies don’t always react equally to the foods we eat. While certain foods don’t produce any reaction in some individuals, those same foods can cause abnormal activity in the immune system in others, creating what most call an allergic reaction. An allergic reactions occur when the body’s immune system misinterprets a specific food or protein as a pathogen (or allergen) with the potential to make you sick. The immune system then goes into defense mode, releasing bodily chemicals to fight off the intruders. According to the Food Allergy Research & Education (FARE), there are up to 15 million Americans with food allergies, including 5.9 million children under the age of 18. About 30 percent of children with food allergies are allergic to more than one food.

An allergen is any substance that is recognized by the immune system and causes an adverse reaction. According to the Food Labeling and Consumer Protection Act (FALCPA), more than 160 foods have been identified as the cause of food allergies in sensitive individuals. However, only eight foods or food groups have been identified as responsible for the majority of food allergies among Americans and they account for over 90% of all documented food allergies. They are milk, eggs, fish (e.g., bass, flounder, cod), Crustacean shellfish (e.g., crab, lobster, shrimp), tree nuts (e.g., almonds, walnuts, pecans), peanuts, wheat, and soybeans.

A true food allergy is different from a food intolerance of sensitivity. Food allergies cause a range of symptoms, some of which can be life-threatening, whereas food intolerances or sensitivities generally produces less severe symptoms and most of those symptoms are limited to the digestive system. Reactions to food intolerances occur when the body is unable to properly break down food either due to enzyme deficiencies or sensitivities to additives and chemicals in food. you are unable to properly break down the food.

Unlike food intolerance, which most people can handle and is not generally life-threatening, food allergies can be triggered even through simple contact or inhalation. Symptoms of allergic reactions include hives, itchiness, and skin inflammation to vomiting and diarrhea. The most severe reaction is “anaphylaxis”, which includes breathing distress or even loss of consciousness. Without prompt medical attention, anaphylaxis can even be fatal.

The best way to prevent allergies from flaring up is simply to avoid these common triggers. After all, you cannot have an allergic reaction to an ingredient you didn’t eat, right? Unfortunately, that’s not always the case. As people with food allergies know, it is possible to have an allergic reaction without consuming any of the allergenic ingredients.

There are often many risks hidden in the ingredients, processing aids, and chemicals used in the manufacturing of foods and supplements. And unless special care is taken to avoid high-risk allergenic ingredients in formulations and to prevent cross-contamination with allergens during the production process, almost anything we ingest can be a source of allergic reactions.

Dietary supplements can produce an allergic reaction in sensitive individuals either because they contain ingredients from high-risk allergens like soy or peanuts, or due to cross-contamination with high-allergen ingredients during manufacturing. And although food intolerances and sensitivities are not generally life-threatening, their presence in dietary supplements can produce undesirable side effects.

At NutriGold, we know that consumers expect dietary supplements to be a safe and convenient approach to health management. This expectations of safety demands that manufacturers pay attention to active ingredients and additives, and ensure that products are manufactured in compliance with best practices for avoiding allergens and minimizing cross-contamination risk. It is also important that allergens, if present, are declared accurately and transparently on product labels so consumers can purchase the products that best meet their needs.

Given that approximately 50% of the U.S. population routinely takes a dietary supplement and ingredients derived from allergenic foods are routinely present as an active ingredient or additive in a number of them, we voluntarily perform a six-step allergen verification process to ensure that our products are safe for even the most vulnerable members of our population. This comprehensive verification process allows us to offer customers the cleanest products possible, , regardless of whether they have allergies or not. And as a consumer-centric, quality-conscious company, we are committed to doing everything we can to stay true to our fundamental guiding principle to “do no harm.”