Comprised of various individual amino acids that define the precious molecule that enables life, proteins vary greatly in what they do. The issue with protein, especially when considering regulatory matters in the U.S., is in the commonly unenforced sections of the regulations. This is not to say that one day FDA may suddenly start increasing enforcement … Such activity is imminent. All of that caveat provided, the situation is an interesting confluence of knowledge, awareness and selection of how to proceed, both with formulation as well as with the labeling of these products. This all begins with some common truths. First, not all protein is created equal. Second, the determination of the differences can be expressed in meaningful terms. Third, there are requirements just for the labeling of the products (whether foods or dietary supplements) that involve knowledge of the quality of the protein provided. The bottom line is there are some important things to know when formulating a product with specific emphasis on or even simply inclusion of protein.

When the original regulations concerning the labeling of foods came out shortly after the passage of the Nutrition Labeling and Education Act (NLEA) in the early 1990s, the foundational requirements were set out for the quality requirements of the protein being offered. The measurements applicable to protein are protein efficiency ratio (PER) and protein digestibility corrected amino acid score (PDCAAS). When these regulations went into effect, the determination of PER was the key determinant and the range of individual proteins in the market was vastly less broad. The emphasis in today’s regulatory environment (read this as post-2016 when the labeling regulations for foods and dietary supplements underwent an overhaul) is the determination of the PDCAAS for an individual protein as the focal point. Simply put, the ramifications of this are that some proteins will need to be identified as “not a significant source of protein” or a calculated adjustment to the amount of protein provided (take the total amount of protein and multiply it by the PDCAAS to get the actual result. There are two different standards for the need for such correction or declaration, dependent on the age groups. Foods and dietary supplements intended for children between 1 and 4 years of age have a higher PDCAAS score requirement than for adults and children 4 or more years of age (PDCAAS score of 40 minimum and 20 minimum, respectively).

The proteins used in today’s products reflect an array of quality based on the amino acid composition of the protein. In simplest terms, the measurement is a totaling of the levels of the individual essential amino acids (EAAs – phenylalanine, valine, threonine, tryptophan, methionine, leucine, isoleucine, lysine and histidine) and correcting the total by a factor knows as the protein’s digestibility score. This latter number is often overlooked as relevant, but it is necessary to accurately identify the PDCAAS for a protein. The determination of this factor is performed using animal models to establish the score. Thus, work must be done in order to assess the quality of the protein used.

Since proteins come from a variety of sources, it is challenging to ensure an appropriate PDCAAS is applied to one’s product. This is not overly important provided a protein is complete (containing all nine EAAs) and is likely to score well. That said, a couple challenges exist with this situation. The first is whether the protein includes all the EAAs. If not—for example, a product is missing histidine—one cannot present a percent daily value (%DV) and must identify that the product is “not a significant source of protein,” even if a single serving provides a full (50 g) daily reference value (DRV) of protein. It’s just not the right kind. Then consider that non-animal proteins typically have lower PDCAAS scores even though they may be complete.

Should a product manufacturer know the details of the protein score for its product? Absolutely. If called to task to justify the protein claims on its label, the company must be prepared to discuss the PDCAAS for the formula. Remember, should a brand rely on a single protein source that is absent one of the EAAs (resulting in a PDCAAS of zero), it may not make claims concerning its protein—nor is it allowed to present the %DV for this nutrient.

The solutions to these more future challenges from a regulatory perspective start, as with most things, with the ingredients. Knowing the PDCAAS and amino acid composition of the individual proteins intended for use will begin the documentation process. Development of a sound and sold documentation of the determination from these components to the actual finished product can be sufficient to meet regulatory needs. There’s just the little challenge with the pesky digestibility factor. Multiple resources in the scientific literature discuss and identify such factors for a wide variety of proteins, but are not all-inclusive. This should not be an immediate concern, depending on how low the PDCAAS is. When it’s out of line with what a company desires, redress of the formula is necessary.

In simplest terms, remember that proteins are comprised of amino acids. The addition of individual amino acids to foods for the purpose of enhancing the protein quality is found clearly within the regulations. Thus, adjusting a formulation may be required just to make the simplest claim regarding a protein product.

Regardless of the nature of a selected protein, a brand must know and understand the quality of the protein being delivered, as described in regulations. It’s strongly advised to ensure one’s testing laboratory does as well. This fulfills the requirement and affords the opportunity to know and understand the characteristics of one’s product. All of this is required to be documented, whether the determinations made are the result of calculation or actual testing of the product itself. Compliance is always the requirement … even when the regulatory agency is not pressing for the specifics.

As chief operating officer, Jim Lassiter oversees all consulting operations at REJIMUS, formerly Ingredient Identity. He has more than four decades of experience in quality control (QC), and government and regulatory affairs throughout the pharmaceutical, dietary supplement and natural product industries.