WARNING LETTER
Great Lakes Gelatin Company
MARCS-CMS 612323 —
May 10, 2021
Delivery Method:
Certified Mail
Product:
Drugs
Food & Beverages
Recipient:
Recipient Name
James Burkett
Recipient Title
President
Great Lakes Gelatin Company
253 Commerce Dr., Ste 101
Grayslake
,
IL
60030
United States
Issuing Office:
Office of Human and Animal Food Operations East-VI
United States
WARNING LETTER
FY21-HAFE6-WL-03
May 10, 2021
Re: 612323
Dear Mr. Burkett:
This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address www.greatlakesgelatin.com 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. We have also reviewed your social media websites at www.facebook.com/greatlakesgel/ and http://www.pinterest.com/greatlakesgel/, which direct consumers to your website www.greatlakesgelatin.com, where you take orders for your products. In addition, your website www.greatlakesgelatin.com links to your YouTube channel https://www.youtube.com/channel/UClCQa2KGaAVEw_ROlp-dCAQ. 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) [21 U.S.C. 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. You can find the Act and FDA regulations through links on FDA’s home page at
www.fda.gov.
Examples of some of the website claims that provide evidence that your products are intended for use as drugs include:
Collagen Hydrolysate, Keto Collagen + MCT, and Collagen Endurance Plus products (which, as indicated on your website, contain collagen hydrolysate (also referred to as hydrolyzed collagen))
On your website www.greatlakesgelatin.com:
On the “About Great Lakes Gelatin” webpage of your website:
“We pioneered the ‘original’ Collagen Hydrolysate, and this amazing product has helped thousands of people see the benefits of . . . reduced joint pain . . . .”
On the “Why Collagen” webpage of your website:
Artwork with pop-up text - “Natural, Anti Inflammatory”
On the “Healthy Living” webpage of your website:
“Many of our customers also report that their joint pain or discomfort has eased . . . .”
On the “FAQS” webpage of your website:
“What are the benefits of collagen and gelatin? . . . Reduces joint pain”
Under the blog titled “COLLAGEN SUPPLEMENTATION AND GASTROINTESTINAL HEALTH” on your website:
“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 . . . .”
“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.”
“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 . . . .”
“Many who suffer from leaky gut syndrome use collagen hydrolysate as a supplement to aid in symptom management as well.”
“The amino acids glutamine, glycine lysine, serine, and threonine found in collagen hydrolysate all help . . . . Glycine . . . may protect against stomach ulcers by minimizing unnecessary stomach acid secretion.”
Under the blog titled “COLLAGEN SUPPLEMENTATION AND BONE AND JOINT HEALTH” on your website:
“Collagen may help to:… reduce joint pain … and aid in repair of broken bones.”
“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 has also been shown to stimulate bone forming cells, protecting against excessive bone loss . . . .”
“Several of the amino acids in collagen . . . . Glycine may help to protect against arthritis and histidine can be used to treat rheumatoid arthritis. . . . Phenylalanine helps to reduce arthritic pain.”
“To summarize, supplementing with collagen may help to reduce pain from osteoarthritis, increase bone mineral density, decrease joint pain . . . .”
Under the blog titled “WHY CHOCOLATE HEARTS AREN'T THE ONLY HEART YOU SHOULD BE FOCUSED ON THIS FEBRUARY” on your website:
“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”
Under the blog titled “MEN’S HEALTH MONTH” on your website:
“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 has also been shown to stimulate bone-forming cells, protecting against excessive bone loss . . . .”
“Useful in reducing arthritic pain.”
“Collagen helps to keep blood vessels strong and repair those that may be weak and damaged.”
“Amino acid help to reduce total cholesterol, low-density lipoproteins (LDL) and triglycerides.”
“Helps to eliminate excess toxins that can damage the liver, brain, and nervous system.”
“Assist with regeneration of the liver.”
Under the blog titled “A DIETITIAN’S PERSONAL EXPERIENCE WITH COLLAGEN” on your website:
“Based off of my personal experience supplementing with collagen, I found the product to be solid. . . . I was interested in taking it because I had some knee pain from overcompensating due to a tight hip joint . . . . In approximately 2 weeks of starting the product, I did notice the pain subsiding.”
In the video on your YouTube channel titled “Great Lakes Gelatin: The Natural Way to Renew and Repair”:
Includes image showing list of “Benefits”: “Reduce Joint Pain”
Starting at 2:56: “Especially for people who are Celiac’s or people with autoimmune disease, it’s great in repairing that digestive tract”
On your Pinterest page, on your “Benefits of GLG” board, you pinned “10 Incredible Health Benefits of Gelatin” that links to https://healyeatsreal.com/10-incredible-health-benefits-of-gelatin, which identifies your hydrolyzed collagen products as an option for “get[ting] more gelatin into your diet”:
“Gelatin is basically the cooked version of collagen . . . . gelatin is made up of some unique amino acids (such as glycine, alanine, and proline) . . . . And it’s these amino acids that provide the remarkable therapeutic benefits of gelatin . . . . Gelatin appears to benefit our joints . . . by reducing pain and inflammation that are characteristic of joint diseases such as arthritis.”
“Gelatin also reduces inflammation in the digestive tract . . . .”
“If this isn’t enough, there is also evidence that supports using gelatin to help: . . . Prevent auto-immune conditions”
“Gelatin appears to be highly anti-inflammatory . . . .”
Your websites also contain evidence of intended use in the form of personal testimonials recommending or describing the use of Collagen Hydrolysate for the cure, mitigation, treatment, or prevention of disease. Examples of such testimonials include:
On the “Why Collagen” webpage of your website www.greatlakesgelatin.com:
“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.”
On your Facebook page, in the following posts, which link to your websitewww.greatlakesgelatin.com:
October 22, 2020 post: “5 star review from Roxie’s M. . . . I love Great Lakes collagen. It’s the only collagen that takes away my joint pains.”
September 15, 2020 post: “5 star review from MRS. T . . . This product was recommended to me after a shoulder injury . . . . After 2 weeks using according to the directions, I was hesitant to acknowledge the improvement. I went another week and could not deny it.”
July 27, 2020 post: “5 star review from Majnomad . . . I’ve been drinking Great Lakes Collagen Hydrolysate for several years . . . . I’ve broken just about every bone in my body. I began drinking this collagen after breaking my leg in a motorcycle accident. I truly believe it helps me heal quicker and stronger.”
In addition, when scientific publications are used commercially by the seller of a product to market the product to consumers, such publications may become evidence of the product’s intended use. For example, under 21 CFR 101.93(g)(2)(iv)(C), a citation of a publication or reference in the labeling of a product is considered to be a claim about disease treatment or prevention if the citation refers to a disease use, and if, in the context of the labeling as a whole, the citation implies treatment or prevention of a disease. The following are examples of citations to scientific publications or references you use to market your products for disease treatment and prevention on your website www.greatlakesgelatin.com:
Collagen Hydrolysate, Keto Collagen + MCT, and Collagen Endurance Plus products
Under the blog titled “COLLAGEN SUPPLEMENTATION AND BONE AND JOINT HEALTH” on your website:
• Moskowitz, Roland. Role of collagen Hydrolysate in Bone and Joint Disease. Seminars is Arthritis and Rheumatism 2000; 30(2): 87-99.
• Porfirio, E., Fanaro, G. Collagen supplementation as a complementary therapy for the prevention and treatment of osteoporosis and osteoarthritis: a systematic review. Rev. Bras. Geriatr. Gerontol; 2016 19(1): 153-164.
Collagen Hydrolysate (10 oz unflavored, 16 oz unflavored, Convenience Pack (20 count unflavored), 8lb unflavored) products, which contain Type I collagen as indicated on your website
Under the blog titled “COLLAGEN SUPPLEMENTATION AND GASTROINTESTINAL HEALTH” on your website:
• Ramadass, S., Jabaris, SL., Perumal RK., HairulIslam VI., Gopinath, A., Madhan, B. Type I collagen and its daughter peptides for targeting mucosal healing in ulcerative colitis: A new treatment strategy. European Journal of Pharmaceutical Science 2016 91:216-224.
Your Collagen Hydrolysate, Keto Collagen + MCT, and Collagen Endurance Plus products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” under section 201(p) of the Act [21 U.S.C. 321(p)]. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.
A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.
Your products Collagen Hydrolysate, Keto Collagen + MCT, and Collagen Endurance Plus products are intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, Collagen Hydrolysate, Keto Collagen + MCT, and Collagen Endurance Plus fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C. 331(a)].
This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
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. If you cannot complete addressing these violations within fifteen working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
Your response should be sent to U.S. Food and Drug Administration, Lauren Crivellone, Compliance Officer, Food and Drug Administration, 550 West Jackson Boulevard, Suite 1500, Chicago, IL 60661. If you have any questions with regards to this letter, please contact Lauren Crivellone at (312) 596-4157 or email lauren.crivellone@fda.hhs.gov.
Sincerely,
/S/
William R. Weissinger
Program Division Director
Office of Human and Animal Food
Operations East-VI
Content current as of:
05/25/2021
Regulated Product(s)
Drugs
Food & Beverages