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Growing market/regulatory compliance
7/3/2018 9:47 AM
Supplement and nutritional manufacturing is a rapidly growing industry with U.S. sales topping $36 billion in 2017. But more products mean more recalls. In fact, 60 percent of FDA annual recalls of supplement products stem from labeling issues.
These issues include: Absence of an ingredient claimed on the label, inclusion of an ingredient omitted from the label, a higher or lower amount of the ingredient than what is claimed on the label, label layout that does not conform to regulations, undeclared allergens and illegal or improper use of content claims. Supplements may also be recalled due to contamination or because they meet the FDA definition of a drug and must be regulated as such.
Demand for supplements and nutritionals is at an all-time high, but the technology is lagging far behind—there are few useful tools available on the market. We ESHA Research recognized this lack, so we reached out to industry leaders and listened to what they wanted in a comprehensive supplement formulation and labeling solution.
Then, two years ago, we unveiled the first all-in-one supplement-development program; Genesis R&D Supplement Formulation and Labeling software; to simplify data calculation and regulatory compliance, and incorporate other necessary processes.
Ingredient Tracking & Formula Creation
Before using Genesis R&D Supplements, many of our customers were using spreadsheets and hand calculations for nutrition analysis, product formulation and costing, which is an error-prone and tedious process.
With Genesis R&D Supplements, users first enter in ingredient data, which is stored in the database, then quickly create formulations from the ingredients.
Each ingredient in the database is created by entering active and inactive components and their corresponding amounts, which could be by weight, volume or percent. Information can include cost, shelf life, percent organic, chemical impurities and supplier. Additionally, ingredients can be organized by supplement type such as vitamin, mineral, herb, etc., or by defining characteristics such as gluten-free, vegan, organic, etc.
The ingredients entered are used to create formulas. Formulas can contain both individual ingredients and other formulas and users can enter batch information and serving sizes to automatically calculate batch cost from ingredient costs.
In addition, ingredients and formulas are all stored in one place, with searchable tags and other filters that allow for organized file management and quality control measures, including a process to review data. As a result, many of our customers say they’ve been able to catch data entry errors much earlier.
One of the most significant benefits of the Genesis R&D Supplements program is that it lets users quickly create regulatory-compliant labels for their product packaging.
For Supplement Facts labels, the standard nutrients (such as calories, fat, carbohydrates, vitamin C, etc.) are governed by Nutrition Labeling and Education Act (NLEA) rules regarding nutrient name, nutrient order and when they can be listed on the label. They appear above the divider line and most will have a % Daily Value.
The Other Dietary Ingredients will not have an associated %DV and are governed by different NLEA rules that specify the information and order needed.
In both cases, nutrients and Other Dietary Ingredients are only added to the Supplement Facts label if they are present in the product in a significant amount. Additional considerations are governed by the Dietary Supplement Health and Education Act of 1994, and they include guidance for listing blends, showing herbal sources and more.
For each formula created, Genesis R&D automatically creates a regulatory-compliant label that conforms to the rules set out by both the NLEA and DSHEA. Users can fine-tune the label’s font, layout and items listed on it. Labels can be exported as a vector file to be used by graphic designers in creating the packaging.
The FDA requires labels to disclose the presence of any of the eight major allergens—milk, eggs, fish, shellfish, tree nuts, peanuts, wheat or soy—in foods or supplements.
In Genesis R&D, as long as the allergen data was correctly entered for the ingredient, any allergen statement for any formula using that ingredient will automatically list the allergen, and the allergen can be displayed on the label with the click of a button.
Chemical Impurities Tracking
Chemical Impurities are components found in ingredients that (when consumed in high doses) are known to be toxic for humans. Legislation, such as California Proposition 65, requires companies to inform the public about the presence of certain materials in the products they sell. Genesis R&D lets users track and report chemical impurities while highlighting when the amount in a formula exceeds designated thresholds as laid out in Prop. 65 for lead, cadmium, mercury, tungsten and arsenic.
Percent Organics Tracking
Using the word “organic” on a supplement package requires certain parameters to be met. When a supplement contains only organic ingredients, the bottle can say “100% organic.” To use "organic" on packaging, the product must contain at least 95 percent organically produced ingredients. The remaining ingredients can be nonorganic only if they aren't available in organic form, or if they are exempt per the National List.
The packaging can also claim that the supplement was made with a specific organic ingredient, but only if the total amount of organic ingredients is at least 70 percent.
With Genesis R&D Supplements, each time a formulation is adjusted, with added ingredients or changes in amounts, the percent organics is automatically recalculated; no hand calculations are needed. If the organics percentage is below the target threshold, the program will highlight the new total in red.
Reports and cGMPs
A quick browse through the FDA’s warning letters and it’s clear that the industry struggles with Current Good Manufacturing Practice (cGMP) records and labeling compliance. Despite the name, the cGMP protocols cover much more than manufacturing. In the case of supplements, cGMPs include keeping a record of each step of the supplement-creation process.
The FDA requires that manufacturers keep records of the batch history of the product. Genesis R&D Supplements includes tools and fields for users to document such information as inspection dates, batch cost, batch testing, formulation history and more. Old records can be kept in the archive and stored indefinitely in accordance with cGMP rules.
Genesis R&D Supplement Formulation and Labeling software incorporates features based on input from the supplement-creation industry to help users both simplify their tasks and increase accuracy. To do this, we employ a team of researchers who stay abreast of current regulations, upcoming changes and industry trends. These experts work with government agencies and industry leaders to understand and meet the needs of supplement manufacturers. The development team is constantly working on ways to refine and improve the program’s workflow and incorporate recommended updates.
About ESHA Research: Founded in 1981, ESHA Research offers a variety of nutritional analysis and label development solutions to ensure regulatory compliance. Our software programs and databases have been used all over the world by food manufacturers, educational facilities, restaurants, healthcare facilities, and other industry institutions for nutrient analysis, labeling, product development and more. In addition, ESHA Research offers software and regulatory compliance consulting and label-generation services.
ESHA’s suite of nutritional software products, services and databases are recognized as the industry’s top choice for food and supplement formulation, recipe development, labeling, nutritional analysis and regulatory compliance.
ESHA’s software acts as the interface and central hub used daily by industry professionals to advance their ideas through each facet of the development process and connect their products to nutritional data thereby accelerating the movement of their goods and services to market.
Our mission is to remove the complexity of product development and regulatory compliance for the food, beverage and supplement industries through innovative software, expert services and unparalleled nutritional databases.