A Word on FDA Labeling

The FDA has categorized requirements for product claims. A cosmetic or personal care item, a supplement, an over-the-counter drug, and a prescription drug all must meet FDA requirements before certain things may be claimed. I personally take certain over-the-counter and prescription drugs. I prefer to use natural remedies where possible, but I stick to FDA approved, clinically trialed and “regulated” drugs when necessary. Two supplements I currently use are MSM (methane sulfonyl methane) and trimethyl glycine (betaine or TMG). I formulate skin serums from them (cosmetic/personal care use). Occasionally, I take each in small amounts diluted in hot water. You may spend some time reading reputable literature and primary research to determine why I might do so. That said, neither are FDA approved over the counter or prescription drugs. They are classified as supplements. As such, the producers cannot openly make claims for why we believe these molecules are beneficial. My MSM bottle contains the following statement:

“**These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.”

The bottom line is this – In America, manufacturers and sellers cannot make claims such as treats acne, treats arthritis, or reduces anxiety, without clinical trials to support such claims. As individuals, we may read supporting evidence, research literature, and even an internet blog to determine whether a material or supplement has value and may actually “treat” symptoms or diseases we may wish to alleviate or eliminate. We may prefer all-natural ingredients. We may prefer homeopathic approaches. We may have a belief in herbal medicine and herbalism. We may note that many pharmaceuticals are derived from naturally occurring molecules. We may believe that several ingredients or molecules work in concert to address a problem we wish to treat, and we may note that some pharmaceuticals are powerful, often addictive, single molecules synthesized in factories. There are reasons to choose such compounds, and there are reasons to avoid them. We have a choice. Many choose to take a daily vitamin or several supplements each day.

To the point: Our topical relief products “have not been evaluated by the FDA and are not intended to diagnose, treat, cure or prevent any disease”. We believe in them. We believe in the safety of natural ingredients, carefully chosen and responsibly blended. We choose ingredients used in the flavor/fragrance industry. Plai, turmeric, and ginger are all used in food. Teas and concentrated extractions are made from all three rhizomes. Peppermint, mint, guava, menthol and capsaicin are all found in nature, food and flavoring. We strongly suggest you never eat our products! Their concentration levels are too high for oral consumption. Will our products help you with relief? We believe they will. We use them daily. I’ve developed them based on my own battles with pain and inflammation.