WARNING LETTER
Molecular BioLife International, Inc.
MARCS-CMS 612629 —
April 15, 2021
Delivery Method:
VIA UPS
Product:
Food & Beverages
Recipient:
Recipient Name
Robert A. Den Hoed
Recipient Title
President
Molecular BioLife International, Inc.
200 W 16th St Bldg B
Sheldon
,
IA
51201-2008
United States
Issuing Office:
Office of Human and Animal Foods West Division II
United States
April 15, 2021
RE: CMS CASE # 612629
WARNING LETTER
Dear Mr. Den Hoed:
This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address www.molecularbiolife.com from March to April 2021 and has determined that you take orders there for the products Shark 2 Collagen and Balanced Kollagen. The claims on your website 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:
Shark 2 Collagen
The Latest Research page on your website says, “Click Here for More Information About Shark 2 Collagen,” which links to a white paper about Shark 2 Collagen that includes the following claims:
• “It has been claimed that the components inside shark collagen directly attack and kill cancer cells, and shrink tumors…”
• “Shark collagen is commonly used to treated [sic] osteoarthritis (OA), rheumatoid arthritis (RA), psoriasis, lupus and eczema. It prevents the development of degenerative disorders (like OA and RA) …”
• “…shark collagen supplements … benefits include relief from various ailments (including osteoarthritis and rheumatoid arthritis), the treatment of skin disorders (such as eczema, lupus and psoriasis), …”
• “Shark collagen…and helps remedy symptoms associated with ulcerative colitis, glaucoma, hemorrhoids, muscular degeneration, . . . and osteoporosis.”
• “Shark collagen improves the body’s immune response by enhancing antibody production; this indicates that it is effective against bacteria, viruses and fungal infections.”
• “Shark collagen also . . . relieves general pain…”
• “[A]nti-inflammatory properties…”
• “Shark collagen has anti-angiogenic properties…angiogenesis is vital for tumor growth.”
• “Shark collagen can prevent arthritis (and reduce arthritic symptoms) and inflammation.”
• “Since shark collagen combats inflammation, both psoriasis and rheumatoid arthritis can be prevented and treated. For example, the itching sensation associated with psoriasis can be substantially reduced.”
• “[S]hark collagen has the ability to treat arthritis…”
• “A study conducted in Mexico with terminal cancer sufferers illustrated the powerful effects of taking shark collagen supplements…five patients became tumor free, two had an 80% tumor reduction…”
• “A similar clinical trial was conducted and it was found that not only does the use of shark collagen protect against the side effects of chemotherapy, it leads to various improvements—out of eight participants, six were in remission in merely three months.”
• “Shark collagen supplements have been found effective in treating…inflamed jaw joint problems.”
• “[T]his Shark Collagen preparation…has significant benefits for people with …severe pain caused by degenerative diseases such as osteoarthritis, rheumatoid arthritis and other diseases/conditions associated with pain and joint inflammation.”
• “[I]t reduces[s] pain symptoms…”
• “Shark collagen supplements, particularly a Shark 2 Collagen preparation (which is extracted from shark collagen), have proven to be useful for various reasons. Some reasons include, but are not restricted to, the following: it relieves general pain, limits and stops the growth of benign and malignant tumors…and remedies pain associated with degenerative disorders such as osteoarthritis and rheumatoid arthritis.”
• “[T]his preparation is a novel, useful substance with significant benefits for people experiencing…severe pain caused by degenerative diseases such as osteoarthritis, rheumatoid arthritis, and other conditions associated with joint inflammation.”
The Shark 2 Collagen product page on your website includes an embedded YouTube video about Shark 2 Collagen that includes the following claims:
• “2 capsules once a day can manage symptoms of arthritis…”
• “. . . relieves symptoms of skin disorders such as eczema and psoriasis…”
• “[C]an…fight chronic fatigue…”
Balanced Kollagen
The Balanced Kollagen product page on your website says, “For more details regarding the benefits of Balanced Kollagen click on the link Below! Balanced Kollagen White Paper,” which links to a white paper about Balanced Kollagen. The Latest Research page on your website says, “Click Here for More Information About Balanced Kollagen,” which links to the same white paper. This white paper includes the following claims:
• “This contrasts the highly underestimated oral based collagen format called Balanced Kollagen, which is proven to prevent chronic illnesses, relieve pain...”
• “Oral collagen serves many purposes, one of which is to prevent joint disorders (like osteoarthritis…”
• “…[O]ral collagen can both promote the synthesis of muscle protein and strengthen bones; ergo, diseases like sarcopenia (excessive muscle degradation and loss of muscle power) and osteopenia (the precursor to osteoporosis) can be prevented.”
• “Additional benefits of taking oral collagen include . . . the rebuilding of multiple organs (such as the heart, prostate, lungs, liver, kidneys, and blood vessels). The rebuilding of multiple organs serves various functions, including protecting against heart disease. . .”
• “The glycine in collagen calms the central nervous system, thus reducing anxiety… Glycine also inhibits an overproduction of testosterone and estrogen; excess estrogen may lead to . . . diabetes and increased risk of breast cancer …”
• “[E]gg membrane [an ingredient in Balanced Kollagen] is a rich source of many nutrients like glucosamine, collagen, chondroitin, hyaluronic acid and amino acids, all play a key role offering relief from joint pain and stiffness as well as combating connective tissue disorders. Another key aspect is that extracts from the membrane ease osteoarthritis and CJD symptoms.”
• “In retaining its structure, immune cells recognize Balanced Kollagen as the body’s own tissue, not as a foreign invader, to prevent inflammation and thus OA and RA.”
• “Like Type II collagen, egg membrane is also proven to lead to decreased pain…”
• “Collagen X . . . is commonly used to treat rheumatoid arthritis, osteoarthritis, lupus, gout and fibromyalgia…”
• “. . . Balanced Kollagen, which is shown to ameliorate chronic health problems such as arthritis, osteoporosis and obesity.”
Your 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 based on 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” mean 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 Shark 2 Collagen and Balanced Kollagen 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, Shark 2 Collagen and Balanced Kollagen 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 working days of receipt of this letter, of the specific steps 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 corrective actions 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, 8050 Marshall Drive - Suite 205, Lenexa, Kansas 66214-1524 or by email to Danial.Hutchison@fda.hhs.gov.
Sincerely,
/S/
Jeffrey Moody
Acting Program Division Director
Office of Human and Animal Foods
West Division II
Content current as of:
06/22/2021
Regulated Product(s)
Food & Beverages