¹ Department of Standards, Paleo Foundation, New York, NY
² Department of Standards, Paleo Foundation, Encinitas, CA
Department of Standards, Paleo Foundation, New York, NY
In 1925, Dr. Peterman first provided the strict requirements of the Ketogenic Diet but did not specify which foods were allowed or restricted. While public acclaim for the diet is growing, it has not yet become a primary therapeutic option due to its difficulty to adhere to and its serious side effects. The Paleo Foundation created KETO Certified Standards to help standardize the ketogenic diet while improving tolerability through the certification of compliant foods.
KETO Certified, KETO Certification, Net Carbohydrates
Statement of Purpose
In the early 20th century, nutrition experts explored diets that would effectively alter metabolism. One of those diets, created by Dr. Peterman in 1925, was the Ketogenic Diet. This diet was unlike any other low-carb diet at the time; its requirement that 1g of protein per kilogram bodyweight be consumed and a strict limitation of carbohydrates meant a heavy reliance on fats and proteins as staple foods. While the diet successfully ameliorated seizure activity, Dr. Peterman did not offer specific requirements about carbohydrate sources or what specific food groups should have been allowed or restricted.
Despite its potential to replace pharmaceuticals, the diet failed to become a primary therapeutic option due to its difficulty in adhering to it, as well as serious adverse effects. Several reports showed that compliance to the diet is poor, with some patients dropping out or requiring different modifications in only a few weeks following the initial start of their program. Thus, despite its possible benefits for pharmaceutically-resistant epileptic seizures, the diet is still considered risky and is rarely chosen by physicians over other treatment interventions.
The Paleo Foundation recognizes the importance of making dietary changes as easy and sustainable as possible – after all, there’s no use in starting a diet if you won’t stick to it. To improve this, they’ve taken initiative and implemented KETO Certified Standards. This has yielded significant improvements in the tolerability and convenience of compliant foods. There’s now more motivation for people to stay on track with their lifestyle due to the various improvements brought about by KETO Certified Standards. With The Paleo Foundation striving to make life easier for the community, adherence is expected to continue to increase over time.
1. Keto Certified Label
The “Keto Certified “Standards apply to all products certified by The Paleo Foundation for the Keto Certified program. Only products following the Keto Certified standards are explicitly given the rights to use federally registered Keto Certified logos, trademarks, certification marks, or other design marks hereinafter referred to as “Keto Certified label”.
1.1 Applicability. The Keto Certified label was developed and trademarked by The Paleo Foundation to identify food products that meet the standards of the ketogenic diet. The Keto Certified label is a certification mark with the use permitted only to those who have entered into a contractual agreement with the Paleo Foundation. The Keto Certified label was designed to establish an easily identifiable mark indicating that a product has met the strictures of the ketogenic diet and merit use of the Keto Certified label.
1.2 Guidelines for Keto Certified Producers
1.2.1 Promotional Materials. The Keto Certified label is allowed to be used on any company advertising materials, including packaging, promotional materials, point-of-purchase materials, websites, sales literature, banners, and company stationery, provided that the use of the Keto Certified label complies with the guidelines outlined in the Keto Certified Standards. If a company wishes to present the logos in a manner other than as described as outlined in section 1.3, The Paleo Foundation must approve the request and give written permission to the producer.
1.2.2 Display. Producers may display the Keto Certified label only on products that have been certified by The Paleo Foundation.
1.2.3 Agreement. Producers must have a contractual agreement with The Paleo Foundation to use the Keto Certified label.
1.2.4 Stationary. Producers may only use the trademark on company stationery if the entire product line has been audited and Keto Certified.
1.2.5 Logo Placement. If the entire product line has been audited and Keto Certified, producers may display the Keto Certified label on their entire website. If the entire product line was not certified, the Keto Certified label may appear on a page containing the audited and certified Keto Certified products only. Products that have not been audited and Keto Certified are not permitted to appear on the same page as the Keto Certified label, as this could mislead consumers.
1.3 Use of the Registered Keto Certified ® Label
1.3.1 Affidavit. To complete the application process, the applicant must sign an affidavit stating that all answers and statements provided in their application were true to the best of their knowledge.
1.3.2 Inspection and Audit. Use of the registered Keto Certified label is only permitted after the audit and certification of the applicant’s products by The Paleo Foundation.
1.3.3 Authorization. The Paleo Foundation retains the right to inspect, audit, and conduct net carbohydrate lab tests of the producer’s products to verify that all requirements are met.
1.3.4 Prohibited Use. Use of the Keto Certified label for any product that does not meet each of the Keto Certified Standards, that has not been audited, or that has not been given explicit permission is strictly prohibited.
1.3.5 Misuse. Misuse of the Keto Certified Label will result in immediate suspension of the agreement and/or prosecution.
1.3.7 Orientation. According to the Keto Certified Standards, the Keto Certified label must be:
⓷ Clearly Visible
2. Keto Certified Standards for Carbohydrate Content
The allowed carbohydrate content for based on the USDA standard serving size of a food product.
2.0.1 Meal. Meal and Meal Replacement products must not contain more than 10g net/effective carbohydrates per serving. For products that contain minimally processed, whole-food ingredients or ingredients with reduced digestibility, 12g net carbohydrate per serving is permissible.
2.0.2 Snack. Snack products must not contain more than 6g net/effective carbohydrates per serving. For products that contain minimally processed, whole-food ingredients or ingredients with reduced digestibility, 8g net carbohydrate per serving is permissible.
2.0.3 Condiments. Condiments must not contain more than 2g net/effective carbohydrates per serving. For products that contain minimally processed, whole-food ingredients or ingredients with reduced digestibility, 3g net carbohydrate per serving is permissible.
2.0.4 Auxilliary Category. Auxiliary Category products do not fit the “normal use” criteria of meals, meal replacements, snack products, or condiments. Auxiliary Category products will be judged on an individual, per-product basis for their eligibility in the Keto Certified program.
2.1 Allowed Carbohydrate Content
2.1.0 Additional Allowances. Meals, Meal Replacements, and Snacks which contain minimally processed, whole-food ingredients or a high concentration of ingredients with reduced digestibility are allowed an additional 2g to be permissible in the Keto Certified Standards. Condiments are allowed an additional 1g per 0.5oz for reduced digestibility or low-usage threshold for the product (such as hot sauce). Quantification of Net Carbohydrates for Keto Certified eligibility may also be determined using a High-Performance Anion-Exchange Chromatography Assay.
2.2 Prebiotic Fiber
Product formulations may be required for accurate dietary fiber calculations. Prebiotic fibers are fermentable fibers that selectively contribute to the growth and maintenance of commensal bacterial species such as Bifidobacteria and Lactobacilli. In the simplest terms, a prebiotic is a selectively fermented ingredient that allows specific changes, both in the composition and/or activity in the gastrointestinal microflora, that confers benefits upon host well-being and health.
The three criteria of prebiotics are that they must be: (a) Resistant to gastric acids, hydrolysis by mammalian enzymes, and gastrointestinal absorption; (b) Fermented by large intestinal microflora; and (c) selectively stimulate the growth and/or activity of intestinal bacteria associated with health and well-being. The non-digestible carbohydrates can be broken down into groups and include: Resistant starches (types I, II, III, IV, V)
The non-digestible carbohydrates can be broken down into groups, and include:
Resistant starches (Types I, II, III, IV, V)
Non-digestible oligosaccharide fibers, including fructooligosaccharides, galactooligosaccharides, xylooligosaccharides, isomaltooligosaccharides , and lactulose).
Non-digestible polysaccharide fibers, including cellulose, hemicellulose, polydextrose, beta-glucans, pectins, mucilages, galactomannans, glucomannans, chitin, and chitosan.
3. Allowed Ingredients for Keto Certification
3.1 Allowed Ingredients. The following ingredients are eligible for the use of the Keto Certified label, provided that they do not exceed total carbohydrate criteria. Allowed ingredients will be amended from time to time as necessary. These ingredients include, but are not limited to:
4. Applicability of Exogenous Ketones
4.1 Exogenous Ketones. Exogenous ketone supplementation is allowed in the Keto Certified program. These include naturally-derived beta-hydroxybutyrate compounds such as beta-hydroxybutyrate mineral salts, medium-chain triglycerides, and ketone esters.
5. Disallowed Ingredients List
5.1 Disallowed Ingredients. The following ingredients are completely disallowed ingredients in the Keto Certified Standards. Additional ingredients may be added or removed from this list based on new information or research.
Partially hydrogenated trans fats such as soybean, margarine, and vegetable oils.
Artificial sweeteners such as saccharin, cyclamate, acesulfame, aspartame, and sucralose. Sugar alcohols (polyols) are permitted.
Artificial flavors are not allowed in the Keto Certified program.
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