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The FDA today released new guidance for sellers of dietary supplements. The guidance addresses how to determine whether an ingredient should be considered a New Dietary Ingredient (NDI), and the requirements for filing a pre-market NDI notification.
FDA said another motivation for providing the guidance is to improve the quality and quantity of NDI notifications. There are an estimated 55,600 dietary supplement products on the market, but FDA has only received about 700 NDI notifications since it began reviewing them 16 years ago. Approximately 1,000 new dietary supplements are introduced to the market each year. The low number of NDI notifications, plus FDA’s concern that some dietary supplements contain undeclared active ingredients, has prompted more attention on using these filings as a preventive monitoring tool.
The agency is inviting response from the dietary supplements industry on today’s guidance.
Dietary supplements are regulated under the Dietary Supplement Health and Education Act of 1994 (DSHEA).
Baxam Law Group advises clients on complying with the regulatory requirements for marketing of consumer products.
- Is It Really FDA Approved? (everydayhealth.com)
Today the U.S. Food and Drug Administration (FDA) issued new rules for labeling sunscreen products. Just in time for next year’s peak summer season (the rules take effect in 2012), the new regulations and guidance may help demystify the many labels consumers must wade through while browsing the drugstore aisles for protection against sun damage. According to Dr. Lydia Velazquez of FDA, “We want consumers to understand that not all sunscreens are created equal.”
SPF is the ability of a sunscreen to block UVB rays, which cause sunburns. The SPF number that has been used on sunscreen packaging gives no indication of how well a product protects the skin from UVA rays which, like UVB rays, can damage the skin, cause wrinkles and other signs of skin aging, and can also contribute to the development of skin cancers (watch the FDA video here). The SPF number also does not indicate how long a person who uses the product can be exposed to sunlight before developing sunburn.
Typically, a product marked SPF 15 will generally block about 94 percent of UVB rays, SPF 30 will block about 97 percent, and SPF 50 will provide about 98 percent blockage.
The new rule sets testing standards for what are called broad spectrum protection products – those that sufficiently block both UVA and UVB rays. Sunscreens that meet these standards and receive a SPF rating of 15 or higher can be labeled with a statement that use of the product may reduce the risks of skin cancer and signs of early skin aging if used as directed and in combination with other sun protection measures.
FDA believes SPF values above 50 cannot be verified with scientific accuracy, and even then they may not necessarily offer adequate protection against UVA rays. Accordingly, the agency also issued a proposed rule today that, if finalized in its current form, would ban the use of SPF designations above 50.
Sunscreens not labeled as “Broad Spectrum,” or which have SPF values between 2 and 14, will now have to labeled with a warning that the product has not been shown to help prevent skin cancer or early skin aging.
Some of the now familiar terms used for sun care products, such as “sunblock,” “waterproof” and “sweat proof” must also now be removed from the labeling. However, products can be labeled as water-resistant under certain conditions.
Large companies will have one year from the effective date of the Sunscreen Rule to change the sunscreen-related labeling on their products, while small companies will have two years to implement the changes.
While traveling outside the US recently, a kindly woman encouraged me to investigate a natural product she said was a “miracle worker” for people managing diabetes as a chronic condition. I forgot all about it for a while, but recently I was reading a supplement label and noticed that name again — Banaba extract. Also known by a host of other names, such as Corosolic acid, Queen’s Crape Myrtle, Pride-of-India, and perhaps more formally as Lagerstroemia speciosa, this extract is being touted by many diabetes sufferers as a good naturopathic option. According to other online sources, Banaba extract may also be helpful in weight loss.
Read more from WebMD about Banaba extract.
If you make or sell natural therapies, contact us learn more about how to label and market your products in compliance with federal rules and guidelines.
Photo from Dave’s Garden.
Baxam Law Group, LLC; www.baxamlaw.com
Today, the Department of Health and Human Services quietly hosted (if that’s possible) a conference call to unveil its new Partnership for Patients initiative. This initiative promised $1B in cash to hospitals, who eagerly participated in the call. HHS says the purpose of this initiative is to find ways to reduce hospital infections and medication errors, and to prevent repeat admission of patients caused by lack of continuity in their care after they are discharged from the hospital environment.
According to HHS Secretary Kathleen Sebelius, “Americans go the hospital to get well, but millions of patients are injured because of preventable complications and accidents.” On this basis, the Partnership for Patients is poised to spend $500M to fund research on best practices and model systems that reduce the occurrence of hospital-acquired infections and hospital errors by 40% by 2013.
The initiative will also provide $500M for the Community-Based Care Transitions Program. Hospitals are expected to use this money to develop ways in which patients can transition from a hospital to other patient care settings in ways that reduce the risk of readmission. The goal is a 20% reduction in the number of patient readmissions by 2013.
Pragmatic hospital administrators who may see this initiative as an oasis of encouragement in the increasingly arid healthcare environment, but they might not have much choice but to do so. What will probably happen somewhere down the road is that hospitals which cannot meet the standards for reduced errors will have to worry about the risk of cuts to their federal healthcare reimbursements.
Read today’s press release here.