Rare enzymes warning letter focuses on blood circulation claims
Enzymes are ingredients that sometimes fly under the radar because of their long history in the industry. Many enzyme ingredients important in the trade have been around for many decades. For example papain, an enzyme derived from papaya, has been produced commercially since the late 1950s.
Enzyme products have been associated with a number of claims, including inflammation reduction, faster wound healing, better digestion and nutrient absorption and others. Along with other metabolic processes, the production of enzymes within the body decreases with age and so supplementation with these specialized proteins is beneficial, or so the argument goes.
In a warning letter posted this week the Agency took a Scottsdale, AZ-based marketer to task for a variety of claims associated with its enzyme-based products. The company, called World Nutrition, Inc., markets products under the Vitälzȳm brand name.
Claims aimed at blood clotting disorders
Many of World Nutrition’s products are aimed at supporting healthy blood flow and enabling the body to maintain a healthy balance of fibrin. Fibrin is the name for the lattice-like structure that forms as a part of wound healing. The structure is formed from the blood protein fibrinogen via an enzymatic process. Too much fibrin, or fibrin that hangs around too long, is implicated in blood clotting disorders.
According to the FDA warning letter, World Nutrition was making claims on its products that included the following:
- “[R]educe chronic inflammation, regulate an over-active or weakened immune system, remove excess fibrin and plaque that may have been building for years, and restore healthy blood flow.”
- “Neutralize rogue proteins in the blood than can trigger a hyper-autoimmune response.”
- “Reduce build-up in the arteries thus improving blood flow and circulation.”
In addition to the blood circulation and inflammation fighting claims, the FDA warning letter alleges the company was also making claims for its enzyme products in relation to the current coronavirus crisis. For example, the warning letter cites the following claim:
“Viruses can enter the human body in different ways, but most commonly (and particularly regarding the Coronavirus) by tiny droplets entering the body through the eyes, nose, or mouth. . . . While most of the world is focused on the coronavirus right now, other well-known viruses include encephalitis, chickenpox, herpes, measles, and the stealth virus. . . . Virus cells have an outer layer made of a protein called the capsid . . . Fortunately, proteolytic enzymes can destroy this protective coating, making the virus easier to destroy.”
Other disease claims
In addition, the warning letter alleges the company claims its products can be useful in treating diseases such as multiple sclerosis, rheumatoid arthritis, celiac disease and psoriasis.
Even though the warning letter includes mention of coronavirus claims, FDA stipulates a 15-day window for the company to respond. In warning letters issued this year in concert with the Federal Trade Commission that focus primarily on COVID-19 related claims, the Agency has shortened the window for companies to remove noncompliant claims language from their websites to 48 hours.