Question

As we all know, there's a lot of information in the news about what's healthy for us and what's not. Scientists use the Scientific Method to determine whether data acquired in laboratory experiments is valid and to direct them to the next question that needs to be asked. As consumers, we can use the Scientific Method as well, not as a scientist but as an educated consumer to help us sort through the information being presented and make determinations about its usefulness.

Choose a dietary "controversy" that can be researched online.  Think about the steps of the scientific method to determine whether the information you've found is valid and/or useful.

Write a paper outlining:

The controversy, the evidence provided,

How, as a consumer, you can have a critical eye as to the validity of the controversy (think of the steps of the scientific method that a scientist may use) and how you use it to analyze the evidence.

What do the reliable sources say about the controversy?

Finally, please speculate on an experiment that could be done to address your controversy.

And, finally, please comment on what you think about the controversy after you looked at it "with a critical eye" as a consumer.

Answer 1

Many of the scientific and regulatory challenges that exist in research on the safety, quality and efficacy of dietary supplements are common to all countries as the marketplace for them becomes increasingly global.

Dietary supplement health products are often very emotive and polarizing topics. While some observers may contend that these products should be considered in a similar fashion to conventional drugs and foods, others believe that a more tailored approach is necessary, there is a traditional or historical evidence base and products often contain multiple ingredients.

Progress in understanding of supplement science as it applies to several nutrients, including vitamin D, iron, omega-3 fatty acids, and iodine. Progress on botanicals and other non-nutrient ingredients has been more challenging

The need for improving quality continues today, there are more than thousands of supplement products in the marketplace and concerns about ingredient misidentification, safety concerns, and quality assurance, control problems continue to be important for the industry and the public.

Reliable analytical methods to characterize the bioactive components in supplements are helpful, but even for the nutrient in supplements, specific analytical chemistry methods must be developed. Reference materials are often unavailable to compare results between different laboratories for research purposes and to monitor data and supplement quality.

Dietary supplements are simply captured under the existing food or drug regulations and legislation with no specific consideration for these products, in some cases specific regulations have developed to reflect the category. Different regulatory models have typically been adopted that reflect their domestic use, national priorities and public health needs.

The determining factor on which approach is applied is largely determined by risk posed to the consumer. Since most dietary supplements when appropriately manufactured are considered to be inherently low risk, increasingly regulatory frameworks are increasingly focused more on post-market review. Different approaches to the definition and regulation of dietary supplement health products are evident although they contain some common elements

This approach is primarily post-market in nature. It does contain pre-market elements. For example, manufacturers must hold evidence to support their claims and they cannot make specific disease treatment claims but only claims related to nutritional support

Products are referred as complementary medicines and are legally defined as listed therapeutic good. The legislation does not define these terms, but a comprehensive set of guidelines describes. Most complementary medicines are listed medicines and are managed through an online portal.

One of the recommendations was complementary medicines as a distinct category, allowing mid level claims through a new third regulatory route between the listed and registered therapeutic goods.

It is clear that high quality scientific evidence is required to support the quality of a dietary supplement, from a regulatory perspective.

In countries with long established traditional forms of medicines, specific regulatory frameworks have been developed for these types of products with the type of claim that can be made and the evidence required to reflect this approach.

As the dietary supplement sector matures and develops and the market for raw ingredients becomes more global, establishing a balance between evidence generated by scientific research, that coming from traditional forms of health and healing is becoming increasingly demanding.

As the market for dietary supplements has increased, so has the amount and diversity of scientific evidence and research to support. This market is made more complex when there are conflicting evidence bases and conflicting ways for evaluating them. For example, traditional evidence be evaluated within the framework of traditional healing theories, those of allopathic evidence based medicine. What should be done when evidence from traditional forms of health and healing are not supported by conventional evaluation mechanisms, as randomized clinical trials, and how can consumers, often wanting to explore both conventional and traditional medicine, be supported in making informed choices about including, or not including, these products in their health care options.

Irrespective of the type of health product, high quality science is fundamental to the success of any regulatory framework. Assessments of the safety, quality and efficacy of nutrients and other bio actives are needed to provide the scientific information that regulators the need. The nature and diversity of the sector means that regulators face a number of very specific challenges for these low risk products. These include evaluating traditional evidence, dealing with products that contain multiple bio actives and addressing the growing challenges of ensuring product quality.

Regulatory challenges must be met at the national level, there is a due regard paid to the fact that national regulatory decisions about supplements have global implications.

Science is vital in regulatory settings, and there is no reason that science and regulation should be incompatible. The challenges in supplement science and its regulation provide new opportunities for scientists and regulators to work together nationally and internationally and to cooperate and appropriate harmonize approaches to improve the public health.