Molecular BioLife International, Inc.
FDA issued a warning letter to Molecular BioLife International, Inc. (Sheldon, IA) regarding its products Shark 2 Collagen and Balanced Kollagen, sold at molecularbiolife.com. The company's website made extensive disease-treatment and cure claims — including treating cancer, arthritis, osteoporosis, and multiple organ diseases — that caused the products to be classified as unapproved new drugs under the FD&C Act. FDA also found the products misbranded because they lacked adequate directions for use for conditions requiring licensed practitioner supervision. The company was directed to respond within 15 working days with corrective steps, and FDA warned that failure to comply could result in seizure or injunction.
Flagged claims (15)
2 capsules once a day can manage symptoms of arthritis…
Shark collagen improves the body's immune response by enhancing antibody production; this indicates that it is effective against bacteria, viruses and fungal infections.
. . . Balanced Kollagen, which is shown to ameliorate chronic health problems such as arthritis, osteoporosis and obesity.
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. . .
Collagen X . . . is commonly used to treat rheumatoid arthritis, osteoarthritis, lupus, gout and fibromyalgia…
Shark collagen supplements have been found effective in treating…inflamed jaw joint problems.
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 …
It has been claimed that the components inside shark collagen directly attack and kill cancer cells, and shrink tumors…
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.
This contrasts the highly underestimated oral based collagen format called Balanced Kollagen, which is proven to prevent chronic illnesses, relieve pain...
Shark collagen…and helps remedy symptoms associated with ulcerative colitis, glaucoma, hemorrhoids, muscular degeneration, . . . and osteoporosis.
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 has anti-angiogenic properties…angiogenesis is vital for tumor growth.
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) …
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…
Required actions (2)
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.
Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
Does your site contain similar claims?
The free site audit scans your whole site against every entry in this Atlas. Most nutrition / supplements sites match 3-6 patterns.
Run my free site auditWorried about one specific page, ad, or email? Paste it into the free Claim Checker and see what the FDA and FTC would flag, with the precedent next to each one. No email required.
Check specific copy in the Claim Checker