“Based off of my personal experience supplementing with collagen, I found the product to be solid. Under the blog titled “A DIETITIAN’S PERSONAL EXPERIENCE WITH COLLAGEN” on your website: “Helps to eliminate excess toxins that can damage the liver, brain, and nervous system.” “Amino acid help to reduce total cholesterol, low-density lipoproteins (LDL) and triglycerides.” “Collagen helps to keep blood vessels strong and repair those that may be weak and damaged.” “Collagen has also been shown to stimulate bone-forming cells, protecting against excessive bone loss. Under the blog titled “MEN’S HEALTH MONTH” on your website: as well as it may help to synthesize carnitine which helps to prevent many health issues that involve the heart and circulatory system” “Lysine may aid in reducing triglyceride levels in the blood. Under the blog titled “WHY CHOCOLATE HEARTS AREN'T THE ONLY HEART YOU SHOULD BE FOCUSED ON THIS FEBRUARY” on your website: “To summarize, supplementing with collagen may help to reduce pain from osteoarthritis, increase bone mineral density, decrease joint pain. Phenylalanine helps to reduce arthritic pain.” Glycine may help to protect against arthritis and histidine can be used to treat rheumatoid arthritis. “Collagen has also been shown to stimulate bone forming cells, protecting against excessive bone loss. “Collagen has a therapeutic role in the prevention and treatment of osteoporosis and osteoarthritis including increased osteoblast proliferation, mineralized bone matrix formation, bone preservation and increased bone mineral density.” “Collagen may help to:… reduce joint pain … and aid in repair of broken bones.” Under the blog titled “COLLAGEN SUPPLEMENTATION AND BONE AND JOINT HEALTH” on your website: may protect against stomach ulcers by minimizing unnecessary stomach acid secretion.” “The amino acids glutamine, glycine lysine, serine, and threonine found in collagen hydrolysate all help. “Many who suffer from leaky gut syndrome use collagen hydrolysate as a supplement to aid in symptom management as well.” “In the same study, there was also evidence found that collagen hydrolysate provided an anti-inflammatory effect as well as protection to the intestinal mucosa. “One research study attempting to promote mucosal healing in ulcerative colitis found that by day 13 of supplementing with collagen hydrolysate rectal bleeding completely stopped.” “Many of the amino acids in collagen protect the gastrointestinal tract by regulating stomach acid secretions, preventing stomach ulcers, helping to heal gastrointestinal lining, reducing and preventing inflammation of the GI tract. Under the blog titled “COLLAGEN SUPPLEMENTATION AND GASTROINTESTINAL HEALTH” on your website: “What are the benefits of collagen and gelatin?. “Many of our customers also report that their joint pain or discomfort has eased. On the “Healthy Living” webpage of your website: On the “Why Collagen” webpage of your website:Īrtwork with pop-up text - “Natural, Anti Inflammatory” “We pioneered the ‘original’ Collagen Hydrolysate, and this amazing product has helped thousands of people see the benefits of. On your website On the “About Great Lakes Gelatin” webpage of your website: You can find the Act and FDA regulations through links on FDA’s home page at Examples of some of the website claims that provide evidence that your products are intended for use as drugs include:Ĭollagen Hydrolysate, Keto Collagen + MCT, and Collagen Endurance Plus products (which, as indicated on your website, contain collagen hydrolysate (also referred to as hydrolyzed collagen)) ![]() ![]() 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. Issuing Office: Office of Human and Animal Food Operations East-VI
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