answer:The term "significant levels of Monacolin K" does not have a universally accepted definition, particularly in the context of dietary supplements and their regulation by the United States Food and Drug Administration (FDA). The FDA has taken action against red yeast rice products that contain Monacolin K, particularly when they contain levels that are pharmacologically active, essentially making them analogous to the prescription drug lovastatin. Lovastatin is a statin medication used to control high cholesterol, and Monacolin K is a compound found in red yeast rice that is chemically identical to lovastatin. The concern arises when red yeast rice products contain enough Monacolin K to exert effects similar to those of a prescription drug, including the potential for serious side effects such as muscle and liver damage. The FDA's concern is primarily with protecting consumers from products that have the potential to cause harm or that may interact with other medications a person is taking. The FDA does not specify a particular threshold for what constitutes a "significant level" of Monacolin K in its public communications. Instead, it has issued warnings and taken action on a case-by-case basis against companies whose products contain Monacolin K at levels that could lead to these pharmacological effects, thereby classifying them as unapproved and misbranded drugs under the Federal Food, Drug, and Cosmetic Act (FD&C Act). It is worth noting that the FDA's regulatory actions emphasize the agency's commitment to preventing the sale and distribution of dietary supplements that contain drug ingredients not disclosed on their labels, not necessarily imposing a specific threshold of Monacolin K permissible in these products. This approach allows the FDA to base its actions on the potential health risks posed by the product, rather than solely on the presence of a specific compound. For consumers, healthcare providers, and manufacturers, the key takeaway is the importance of transparency, accurate labeling, and awareness of the potential risks and regulatory scrutiny associated with products that contain pharmacologically active ingredients like Monacolin K.

answer:The FDA has taken action against several dietary supplements over the years, including but not limited to, those containing red yeast rice with monacolin K due to its similarity to the prescription drug lovastatin. However, due to the expansive nature of the FDA's regulatory actions and the ongoing efforts to protect consumers, there isn't a static list of products that have been subject to warnings or enforcement actions. The actions taken can include warning letters, recalls, and advisories to both manufacturers and consumers about specific products that are deemed to violate the Federal Food, Drug, and Cosmetic Act (FD&C Act), either by containing unapproved new drugs, misbranded drugs, or for other regulatory reasons. Regarding red yeast rice products specifically, the FDA has issued warning letters to companies selling these products with significant levels of monacolin K. These actions are based on concerns that such supplements could essentially function as unapproved and misbranded drugs given their content of pharmacologically active components. The specific products and companies targeted by these actions can and do change over time as the FDA continues its regulatory and oversight activities. For the most accurate and updated information on which products have been subject to FDA warnings, recalls, or other enforcement actions, it's best to consult the FDA's official website. The FDA maintains searchable databases and lists, including: 1. **Warning Letters Database**: Where letters sent to manufacturers and distributors for violations of the FD&C Act are compiled. 2. **Recalls, Market Withdrawals, & Safety Alerts**: A list where safety alerts, product recalls, and market withdrawals are announced. These resources can provide more specific information about products that have been identified as problematic, including red yeast rice products and others with health or safety concerns. Remember, the situation is dynamic, and new warnings or actions may be issued as the FDA continues to monitor the market to ensure the safety and wellbeing of consumers.

answer:As of my last update in April 2023, the U.S. Food and Drug Administration (FDA) had taken actions against various companies selling red yeast rice supplements that contained monacolin K levels resembling those found in lovastatin, a prescription drug. These actions include warning letters sent to companies for selling products that are essentially unapproved new drugs and are misbranded under the Federal Food, Drug, and Cosmetic Act. Specific instances of such enforcement actions include: 1. **In 2007**, the FDA issued warning letters to several companies regarding their red yeast rice products. These letters stated that the products were being marketed illegally as they contained lovastatin, the active ingredient in the cholesterol-lowering drug Mevacor. Even though these actions took place over a decade ago, they are indicative of the FDA's stance on red yeast rice products containing monacolin K. Some of the companies receiving warnings in this and subsequent years include Swanson Health Products, Nature’s Value Inc., and Now Health Group Inc. 2. **In 2017**, the FDA issued a warning letter to NatureCity, LLC for its red yeast rice product "TrueHeart," claiming that the product was being marketed illegally as it contained monacolin K. These instances represent some specific actions taken by the FDA against the sale of red yeast rice products containing significant levels of monacolin K. The FDA's primary concern with these products is that they can contain varying amounts of monacolin K, making them akin to taking an unapproved drug with all the attendant risks and without the oversight that comes with a prescription medication. This can include potential side effects like muscle and liver issues, which are associated with statin drugs. It's important to note that the FDA's actions are not static; they reflect ongoing efforts to regulate and ensure the safety of dietary supplements on the market. Consumers looking for the most current information on FDA actions against red yeast rice supplements or any other dietary supplement should visit the FDA's official website, where they can access the latest warning letters, recalls, and safety alerts.

answer:As of my last update in April 2023, the U.S. Food and Drug Administration (FDA) warning letters and enforcement actions typically identify concerns about the presence of monacolin K in red yeast rice products due to its similarity to the prescription drug lovastatin. However, these communications and publicly available summaries of actions usually do not specify the exact amount of monacolin K found in the products in question. This includes the product "TrueHeart" by NatureCity, LLC, which was mentioned in previous discussions. When the FDA issues a warning letter concerning dietary supplements like red yeast rice products, the agency focuses on the presence of significant levels of monacolin K, which make these products unapproved and misbranded drugs under the Federal Food, Drug, and Cosmetic Act. The letters emphasize the legal and health risks associated with marketing these products without FDA approval, including potential side effects and interactions with other medications. They do not typically disclose quantitative analyses of monacolin K content in the public versions of these letters. For detailed, specific information about the amount of monacolin K in a particular product or enforcement action, direct communication with the FDA or reviewing technical documents that may be part of the enforcement process (if publicly available) would be required. In many cases, such detailed quantitative data may not be easily accessible to the public without specific freedom of information requests or similar actions.