Quality

According to the International Standards Organization, quality can be thought of as the sum of all the attributes of a product [or service] that allow it to meet the expectations and needs of the people who will be using it. Problem is, people’s perceptions of quality are as varied as their expectations and needs, and what one individual or group considers to be of “quality” may be rejected as subpar by another. This makes identifying relevant “quality” attributes and establishing the standards against which those attributes will be measured extremely challenging.

Within the nutraceutical industry, the FDA is responsible for ensuring that products satisfy quality requirements before they are authorized for distribution. It fulfills this responsibility by establishing, reviewing, and revising guidelines for Good Manufacturing Practices or GMPs and holding companies accountable for product quality. Although the intent and spirit of the GMP guidelines are well recognized, what most consumers don’t know is that the guidelines specify only the “bare” minimum standards that products must meet before they can be authorized for distribution. And, more often than not, these “bare” minimum standards do not satisfy consumers’ “quality” expectations.

Although having inadequate standards is better than having none at all, the existence of those standards does not automatically guarantee that companies will actually adhere to the prescribed standards. The vague and highly subjective language used to describe the standards gives companies the flexibility to implement whatever methods and processes they deem appropriate to ensure compliance with the stated standards. Consequently, companies not only differ in their interpretation of the guidelines, but also in terms of “how” they comply with them. The implications for consumers? Unreliable and inconsistent product quality across the board.

Bottom line, the current guidelines are problematic because the bar for entry into the industry is low and most companies are content to do just the “bare” minimum, and sometimes not even that, to stay under the FDA’s radar. This has the potential to significantly increase risk of harm to innocent consumers who are either too trusting, too overwhelmed, or not savvy enough to ask the right questions or perform the due diligence required to make purchasing decisions that are safe for them and their loved ones.

At NutriGold, we understand and respect consumers’ right to products that are pure, safe, and authentic, which is why we developed our quality standards with consumers in mind. Quality, to us, is as much as what we choose to include in our products as it is about what we mindfully keep out of them. It is about voluntarily adhering to standards that exceed current GMPs and working with purpose, passion, and integrity to ensure customers’ expectations are reliably met. It is about ensuring that our products are good enough to give to our families because that’s the only way we can justify giving them to yours.

Every choice we make at the company reflects our unwavering and uncompromising commitment to prioritizing the needs of consumers who entrust their own health or the health of a loved one when they purchase our products.

Not all dietary supplements are created equal. Supplements vary considerably across multiple attributes including source and composition of active ingredients, choice of excipients (or additives), potency, serving size, bottle counts, packaging, the claims used to describe/market them, and price. Perhaps the greatest contributing factor to consumer confusion and frustration is the absence of consistent, clear, and reliable quality standards against which to evaluate products by different brands. The result? Consumers are frequently misled into purchasing ineffective, potentially unsafe, product, which ultimately leads to an erosion of trust in the usefulness of dietary supplements to support health and wellness.

Broadly speaking, the FDA’s current Good Manufacturing Practices (cGMP) specify the bare minimum standards that companies must meet to ensure that products authorized for distribution are safe for the general public. More specifically, cGMPs required brands to have written specifications and processes against which products can be evaluated for identity, purity, strength, and composition.

The problem with the GMP standards as they are currently worded is the lack of clarity with regard to their definition, scope, and measurability. And this means companies have considerable flexibility in determining the extent to which they will comply with the standards, interpreting the standards at their discretion, establishing whatever specifications, processes, and methods they deem appropriate, and, in extreme cases, doing just enough to stay under under the FDA’s radar.

At NutriGold, we consider ensuring that our products consistently and reliably meet consumers’ needs and expectations our fundamental professional and ethical obligation to them. We accomplish this by establishing “quality” specifications for our products based on the spirit and intent, and not just the language, of the FDA’s current GMPs.

We consciously choose pure, safe, and proven ingredients for use in our formulations; reject the use of synthetic additives and preservatives; and manuafcture our products to standards that exceed current Good Manufacturing Practices. It is all part of our commitment to ensuring that our products are good enough to give to our families because that’s the only way we can justify giving them to yours.

Vitamins are organic compounds that are essential in very small amounts for supporting normal physiologic and metabolic functions. They are “essential” because the body cannot synthesize them and, therefore, must be consumed either from diet or through supplementation. Although there is little clarity or consensus within the industry on what “natural” means or what its scope is within the context of dietary supplements, most consumers consider nutrients sourced from foods as “natural” and anything that is created in a lab to be “synthetic.”

From a purely chemical standpoint, natural and synthetic nutrients are basically the same: their molecules contain exactly the same numbers and kinds of atoms. However, they differ in terms of their molecular structure and configuration—elements in synthetic nutrients are arranged in a different way than they are in natural nutrients. More specifically, synthetic nutrients are mirror-image duplicates of natural nutrients.

Many companies, consumers, and even the FDA believe that the structural differences between synthetic and natural nutrients are non-significant and inconsequential, but there are reasons, both from clinical and common sense perspectives, to believe that the body can tell the difference. For example, natural vitamin E is not only three times more absorbable than its synthetic counterpart [Prasad 1994], it may contain co-factors, enzymes and other bioactive compounds that work synergistically to provide intended benefits.

But not all “natural” vitamins from “food” are created equal. And one reason for this inequality is that "food" is used indiscriminately and without reasonable justification by dietary supplement companies in combination with other words (e.g. real food, raw food, food state, food grown, food based) to create the illusion that a product is completely natural. In fact, many multivitamin products that are marketed as “food-based” are actually made by adding isolated synthetic vitamins to base of “food” that may include a combination of fruit, vegetable, and/or superfood powders.

These food powders do not alter the structure of the synthetic vitamins themselves, do little, if anything, to increase their bioavailability or absorption, and do not have the power to “trick” the body into thinking that the vitamins are natural.

There are also multivitamin products marketed as raw code, food state, code factors, or whole-food, which are actually fermented vitamins manufactured by "feeding" synthetic vitamins and inorganic minerals to nutritional yeast. Manufacturers of fermented vitamins claim that they use proprietary or “special” processes that allow the chemical vitamins to get incorporated into the yeast during the fermentation process, and this is in a “whole food” form that the body readily recognizes and assimilates efficiently, a claim that critics reject as pure marketing hype.

Unlike synthetic, food-based, and fermented vitamins, “true” whole food vitamins are are not made from or fortified with synthetic vitamins at any point during the manufacturing process like synthetic or fermented vitamins. The essential nutrients are concentrated from foods using processes that preserve the original structure and configuration of the nutrients as they occur in nature. They include naturally-occurring cofactors that enhance their bioavailability and bioactivity inside the body and include other nutrients that may beabsent in chemically-pure vitamins.

AstaReal® is the most clinically studied brand of natural astaxanthin and is backed by over fourteen international patents. AstaReal astaxanthin extracted from Haematococcus pluvialis microalgae in extremely pristine conditions in the US. It has clinically proven broad-spectrum applications in the areas of muscle endurance, eye fatigue, and gastric health.

Curcumin C3 Complex® is an award-winning extract of Curcuma longa root standardized to 95% total curcuminoids and the three individual curcuminoids in a patented ratio shown in clinical studies to deliver therapeutic benefits. Curcumin C3 Complex is NSF® certified to meet potency specifications, which means you can be sure that you are getting the same extract that is used in clinical investigations.

KSM-66® is an award-winning, patented, clinically proven, full-spectrum, and certified organic extract of Withania somniferastandardized to > 5% withanolides from roots alone. KSM-66® boasts an exceptional purity profile with less than 0.1% of withaferin A, a cytotoxin that occurs naturally in the plant, and its safety and effectiveness are backed by clinical studies.

Slendesta® is a clinically proven extract derived from US-grown, white potatoes standardized to a protein found under the skin of the potato called proteinase inhibitor II (PI2). PI2 works by enhancing the body’s release of cholecystokinin (CCK), a natural factor in the body that signals the brain and helps create feelings of fullness and satisfaction. The safety and effectiveness of Slendesta® in managing satiety, supporting weight loss, and reducing waist and hip measurements is supported by 11 clinical studies.

Kaneka Ubiquinol™ is the world’s first and only ubiquinol available as a nutritional ingredient. Derived from Kaneka Q10®, the only all natural yeast-fermented and bioidentical CoQ10 available today, Kaneka Ubiquinol™ is more bioavailable than conventional CoQ10; this means that optimal levels of CoQ10 can be restored quickly and efficiently. A strong lipid-soluble antioxidant, Kaneka Ubiquinol™ protects the body’s cells from oxidative damage and plays an essential role in cellular energy production.

Kaneka Q10®, the only CoQ10 manufactured in the US, is the world’s purest, most thoroughly researched CoQ10 ingredient available Unlike many CoQ10 ingredients that are processed from bacteria or tobacco leaves, Kaneka Q10® is fermented from pure, natural yeast and does not contain the impurities that synthetically processed CoQ10 does. Kaneka Q10® is bioidentical to the CoQ10 produced by the body and helps support cellular energy, stamina, endurance, and overall wellness.