![]() As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. The claims on your websites establish that the products are drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) because they are intended for use in the cure, mitigation, treatment, or prevention of disease. In addition, your website links to your YouTube channel. We have also reviewed your social media websites at and, which direct consumers to your website where you take orders for your products. Food and Drug Administration (FDA) reviewed your website at the Internet address in March – May 2021, and has determined that you take orders there for the products Collagen Hydrolysate (10 oz unflavored and vanilla, mixed berry, lemon + lime, apple + cucumber, chocolate, and chai flavors, 16 oz unflavored, Convenience Pack (20 count unflavored), 8lb unflavored), Keto Collagen + MCT, and Collagen Endurance Plus. Always read the label and use as directed.Issuing Office: Office of Human and Animal Food Operations East-VI.A nitrogen balance is maintained for the support of age related collagen loss and cartilage damageġ00% hydrolyzed collagen powder from bovine.An excellent product for those with a sedentary lifestyle who may suffer from repetitive joint pain or discomfort.Collagen is important to nitrogen balance and may prevent cartilage damage and collagen loss. ![]() Hydrolyzed collagen is the same collagen naturally found in bones, skin & cartilage.Contains amino acids such as glycine, lysine & proline to help build and repair connective tissue. ![]() Contains protein of low molecular weight, providing quick absorption in digestive tract.It is an excellent product for those with a sedentary lifestyle who may suffer from repetitive joint pain or discomfort. A nitrogen balance is maintained for the support of age related collagen loss and cartilage damage. Hydrolyzed collagen will provide the missing nutritional links for most dietary supplements. How does Great Lakes Gelatin & Great Lakes Hydrolysate work? ![]() All grades of gelatin are prepared under the most rigid sanitary conditions. Pharmacopeia, regulated by National Formulary. This special grade of gelatin meets the specifications set forth by the U.S. The end result is an off white dry powder of the utmost purity. The process of converting collagen into gelatin involves several cleansing and purification steps. Essentially, gelatin is thermally denatured (melted) form of collagen that makes the proteins soluble in hot water.Įach stage of the manufacturing process is rigorously controlled in modern laboratories to ensure purity and quality. The extract is purified and dried to form the gelatin powder. To make gelatin, collagen rich materials (such as bovine hide) are cleaned and treated with dilute alkaline, or acid and heat to denature (untangle) the collagen into hot water-soluble proteins. These proteins assemble into fibres which are massive aggregates and do not have defined molecular weights. Individual collagen monomeric proteins have molecular weights of between 95,000 and 125,000 Daltons. Gelatin is a hot water soluble protein extracted from collagen. Great Lakes Gelatin provides the highest type of pure unflavoured edible gelatins. Gelatin is the purified protein derived by the selective hydrolysis of collagen from the skin, the connective tissue and/or bones of animals. Great Lakes Gelatin Co., Collagen Hydrolysate 454g
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