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CRITICALNutrition / Supplements

Great Lakes Gelatin Company

FDA issued a warning letter to Great Lakes Gelatin Company (President James Burkett) on May 10, 2021, after reviewing the company's website, social media, and YouTube channel and finding that marketing claims for its Collagen Hydrolysate, Keto Collagen + MCT, and Collagen Endurance Plus products established intended drug use — specifically for treating joint pain, osteoarthritis, osteoporosis, ulcerative colitis, leaky gut, rheumatoid arthritis, and cardiovascular conditions. FDA determined the products are unapproved new drugs under section 201(p) of the FD&C Act and misbranded under section 502(f)(1) for lacking adequate directions for use. The company was required to respond within 15 working days with corrective steps, and FDA warned that failure to comply could result in seizure or injunction.

Assist with regeneration of the liver.

5 star review from Roxie's M. . . . I love Great Lakes collagen. It's the only collagen that takes away my joint pains.

To summarize, supplementing with collagen may help to reduce pain from osteoarthritis, increase bone mineral density, decrease joint pain . . . .

Collagen helps to keep blood vessels strong and repair those that may be weak and damaged.

5 star review from Majnomad . . . I truly believe it helps me heal quicker and stronger.

Helps to eliminate excess toxins that can damage the liver, brain, and nervous system.

We pioneered the 'original' Collagen Hydrolysate, and this amazing product has helped thousands of people see the benefits of . . . reduced joint pain . . . .

Lysine may aid in reducing triglyceride levels in the blood . . . as well as it may help to synthesize carnitine which helps to prevent many health issues that involve the heart and circulatory system

Gelatin appears to benefit our joints . . . by reducing pain and inflammation that are characteristic of joint diseases such as arthritis.

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.

Natural, Anti Inflammatory

Gelatin appears to be highly anti-inflammatory . . . .

Collagen has also been shown to stimulate bone forming cells, protecting against excessive bone loss . . . .

Amino acid help to reduce total cholesterol, low-density lipoproteins (LDL) and triglycerides.

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 . . . .

If this isn't enough, there is also evidence that supports using gelatin to help: . . . Prevent auto-immune conditions

Many of our customers also report that their joint pain or discomfort has eased . . . .

Glycine may help to protect against arthritis and histidine can be used to treat rheumatoid arthritis. . . . Phenylalanine helps to reduce arthritic pain.

I had very painful knees and was suffering with plantar fasciitis on one foot . . . . It has been a life changing supplement for me . . . . Karen C.

What are the benefits of collagen and gelatin? . . . Reduces joint pain

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.

Especially for people who are Celiac's or people with autoimmune disease, it's great in repairing that digestive tract

Many who suffer from leaky gut syndrome use collagen hydrolysate as a supplement to aid in symptom management as well.

Please notify FDA in writing, within fifteen (15) working days of receipt of this letter, of the specific steps that you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.

Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.

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