Safety Issues

Drug Interactions

A Trusted Brand

Safety is a paramount concern for Schiff Nutrition International. Schiff® products are manufactured according to Good Manufacturing Practices (GMPs) as regulated by the Dietary Supplement Health & Education Act (DSHEA) of 1994, enforced by the United States Food & Drug Administration (FDA). Schiff Nutrition International has successfully passed further accreditations for manufacture of dietary supplements by independent organizations (NFA, NSA). Schiff Nutrition International maintains a large Quality Assurance/Quality Control department with an advanced analytical laboratory. Schiff also validates suppliers by in-person visits and inspections. All these steps help to ensure that ingredients going into Schiff® products are well-tested. In fact, Schiff® guarantees all its products for purity, freshness and labeled potency. Schiff Nutrition International products list a toll-free phone number for information or to report adverse events.

Allergens are listed if an ingredient is sourced from those foods.

1. Safety of Ingredients

The Move Free® Advanced formula itself has undergone two human clinical studies lasting eight weeks. A total of 82 subjects taking the formulation underwent safety analysis. Included in each study were safety measures (blood pressure, heart rate, bloodwork, questionnaires about adverse effects). Adverse events in both studies were infrequent, minor and not different from control groups in incidence and category. Adverse events were not deemed by the investigators to be due to the product. Blood pressure and heart rates did not differ and did not change from baseline values. Routine blood counts and chemistries were not different from baseline and were not different between groups. Bloodwork included markers of liver function, kidney function, electrolytes, cholesterol and glucose. In the second study, INR and partial thromboplastin time (PTT) tests showed no change from baseline or control groups for subjects. Thus, results from safety analysis of two independently-conducted clinical trials did not exhibit any safety concerns (Bucci 2005e; Schiff Nutrition International, recently completed human clinical study, Los Angeles, 2008).

Glucosamine and Chondroitin

After thousands of human-years of use of both Glucosamine and Chondroitin in the United States and Europe (with post-marketing surveillance), a consensus of safety has been acknowledged by reviewers. Glucosamine is derived from shellfish exoskeletons (chitin), and there was previously a concern about potential allergic reactions in persons with shellfish allergies. So far, no convincing cases of allergic reactions due to shellfish allergies have been reported from products from major brands (who have clear chain-of-custody and quality control procedures). In fact, a human clinical study in persons with documented shrimp allergies was conducted with the forerunner to the product, containing Glucosamine and Chondroitin. No allergic reactions were seen under close medical supervision (Villacis 2006). Other investigations have also not found allergic reactions from Glucosamine (Gray 2004; Matheu 1999; Tapadinhas 1982). Since the commercial production of Glucosamine from shellfish (shrimp, crab, lobster, crayfish) exoskeletons employs digestion by both strong alkali (to remove protein from the shells) and boiling in hydrochloric acid (to digest chitin into glucosamine HCL), there should be no protein or peptides remaining from quality suppliers. Thus, there does not appear to be reports of allergic reactions after widespread use of Glucosamine. The allergic potential of Glucosamine from quality-tested products appears to be nil.

Glucosamine was thought to interfere with cholesterol and glucose metabolism at one point in time. These concerns have been directly dealt with. There has been no effect on cholesterol levels from Glucosamine in any study (thousands of subjects) or post-marketing surveillance (tens of thousands of subjects over multiple years of use). Thus, there is no concern about Glucosamine affecting cholesterol or blood lipid levels.

Glucosamine is produced in cells as an intracellular glucose sensor and safety-valve to reduce high intracellular levels of glucose. When intracellular Glucosamine levels reach high levels (higher than that obtained by oral Glucosamine administration), a cascade effect is stimulated that reduces transport of GLUT-4 receptors to the cell surface, an effect that mimics insulin resistance. This has been shown in animal studies after intravenous administration of large loads of Glucosamine and in vitro at very high Glucosamine doses (unobtainable after oral administration). Prospective human studies have found that 1500 mg of Glucosamine daily did not alter glucose or insulin metabolism in healthy adults, adults with joint discomfort or Type II diabetics under medical care (Biggee 2007; McClain 2000; Monauni 2000; Muniyappi 2006; Pouwels 2001; Scroggie 2003; Tannis 2004; Yu 2003). Retrospective studies and safety reviews have also not found adverse effects of Glucosamine on glucose or insulin metabolism (Anderson 2005; Institute of Medicine 2004; Marshall 2006; Samson 2007; Stumpf 2006; Tapadinhas 1982). One note of caution remains – Biggee et al (2007) noticed that three subjects given 1500 mg Glucosamine Sulfate who were apparently undiagnosed diabetics did show a larger 3-hour AUC for blood glucose after a 75 gram glucose oral glucose tolerance test (but no change for insulin AUC). However, the long-term use of Glucosamine was not associated with changes in glucose metabolism in diabetic humans (Scroggie 2003) or diabetic animal models (Echard 2001). Thus, Glucosamine appears to have no demonstrable safety concerns when used at 1500 mg daily. However, Glucosamine has not been studied during pregnancy, and therefore, its use during pregnancy should be evaluated by a health care professional.

Like Glucosamine, Chondroitin has been used for decades in tens of thousands of subjects without any clear evidence of associated side effects or drug interactions. Chondroitin occurs normally in the bloodstream and tissues and foodstuffs. Commercially, Chondroitin is usually extracted from bovine, porcine or ovine tracheas; chicken cartilage (sternum) or fish/shark cartilage. Specifically, because chondroitin and heparin sulfates are technically in the same class of compounds (GAGs), there has been confusion over inappropriately attributing heparin-like anticoagulant effects to chondroitin. Anticoagulant properties for chondroitin have not been found or observed after oral administration. In fact, the anecdotal observations of improved joint health in subjects involved in anticoagulant trials using chondroitin was the genesis of joint health use for chondroitin. Anticoagulant effects of oral chondroitin sulfate were not observed, and research in this field was halted in the 1960s. Reviews of chondroitin have repeatedly not exhibited safety concerns or drug interactions (Reichenbach 2007; Samson 2007; Simanek 2005; Uebelhart 2008; Zhang 2008).

Hyaluronan (HA)

Oral use of HA is very recent, and thus, no data exists to evaluate safety in a systematic manner. HA is normally present in all body fluids, including plasma (Laurent 1992), and present in animal foodstuffs. Clinical studies included HA at 3.3 mg daily (Bucci 2005e; Schiff®, recently completed human clinical study, Los Angeles, 2008), and a recent human clinical study used 80 mg HA daily (Kalman 2008). No adverse effects were observed, suggesting that oral use of HA is not associated with serious adverse effects.

MSM

MSM use in humans has not been associated with adverse effects, and animal toxicity indicates a very high safety threshold (Horvath 2002; Magnuson 2007). MSM has recently been granted self-affirmed GRAS (Generally Recognized As Safe) status by the US FDA, acknowledging its safety.

Vitamin D

Vitamin D at 800 IU daily is recognized as a safe intake by leading experts worldwide (Hathcock 2004; Hathcock 2007; Jones 2008; Vieth 1999). Schiff® uses the natural-form Vitamin D3 (cholecalciferol) extracted from fish or sheep wool lanolin, not the synthetic Vitamin D2 (ergocalciferol).

Uniflex®

Since Uniflex® is specific to the product, not well-known in the United States and consists of concentrated herbal extracts, a more comprehensive treatment of safety data will be given. Lines of evidence that support a high threshold of safety for Uniflex® are as follows:

• Catechin is found in many plant-based foods commonly consumed; baicalin is structurally similar to quercetin, also found in many commonly eaten plant-based foods.¹
• Increased intake of flavonoids (mostly as isoquercetin, the predominant form of quercetin in foods) is associated with improved health outcomes.²
• Flavonoid intake from a mixed diet approximates 1000 mg daily – Uniflex® contains no more than 250 mg of flavonoids daily (500 mg daily during the loading phase) – thus, the product contains less than an average daily intake of flavonoids, in the range associated with improvements in health. Catechin was used in the 1970s-1980s in high doses (1500 mg daily or more) for humans with liver conditions with good safety.³
• Chinese Scullcap, its extracts and baicalin have been used traditionally in China for centuries and also as a medicine recently, accumulating safety data from clinical trials.⁴
• Reviews of Chinese Scullcap and baicalin use from China report a high safety threshold.⁴
• Herbal combinations containing Chinese Scullcap are currently used in Japan for improving liver conditions under Kampo regulatory status.⁵
• Two human clinical studies with 82 subjects showed the formulation (containing Uniflex®) had a side effect profile not different from control groups.⁶
• Black Catechu is GRAS as a food flavoring, and Chinese Scullcap is also considered GRAS. Therefore, both components of Uniflex® are GRAS, indicating a high level of safety.
• The active ingredients in Uniflex® are being marketed as a medical food. Post-marketing surveillance of over 42000 subjects found an extremely low rate of reported side effects (0.09%).
• The mechanism of action, known metabolic pathways and lack of effects on liver cytochrome P450 enzymes for Uniflex® and its components do not suggest side effects or drug interactions are expected for doses of typical use or higher.⁷
• Animal toxicology studies (acute and subchronic) show Uniflex® has a high degree of safety at intakes up to 35 grams per day for a human.⁸
• Animal toxicology studies found no alterations to gastrointestinal linings or liver histology, indicating no propensity for ulcer formation or liver damage.⁸
• Uniflex® did not exhibit mutagenic or genotoxic actions.8 (Note: Uniflex® has not been tested in pregnancy or nursing conditions.)
• A human clinical study conducted at Georgetown University specifically to monitor safety measurements found no difference from placebo after sixty days of 250 mg Uniflex® daily.⁸
• Additional human clinical studies on Uniflex® alone have not found any differences in safety from placebo.⁹
• Numerous in vitro and animal studies on Chinese Scullcap and baicalin have found no evidence of damage to liver ultrastructure (histological observations) or function; instead, liver protection has been reproducibly found.¹⁰

Uniflex® has been extensively characterized with respect to its safety, both as the combination and as its individual components. Much like other plant-based polyphenols, Uniflex® and its components exhibit a high degree of safety supported by evidence from in vitro, animal and human investigations.

Safety Summary for Move Free® Advanced

Data on children and pregnant/nursing women are not available for most ingredients and thus, persons in these settings should seek advice from a physician before use, as a general precaution. Also, persons with serious diseases or poor health should consult their physician before use of this or any other dietary supplement.

Safety data on the individual ingredients and specific investigations on the formula itself show a high degree of safety, both in laboratory studies and real-life usage. Safety data for each ingredient is extensive and ranges from preclinical to clinical evidence, including the specific active ingredient, Uniflex®, as well as the product itself.

Unflex® Safety References

Privacy Statement  Ι Terms Of Use Ι About Us
© 2010 Schiff Nutrition Group, Inc.