FDA Draft Guidance Signals Regulatory Relief for Low-Risk General Wellness Devices

What Are Low-Risk General Health Products?

This draft currently has no strict legal force; it merely represents the Center for Devices and Radiological Health, an agency under the FDA.(CDRH) current strategic direction, and this draft does not apply to other FDA centers responsible for drugs, biologics, dietary supplements, food, or cosmetics.Under the draft, products that meet two criteria are classified by the CDRH as general health products:For general health purposes only; poses an ultra-low risk to the safety of users and others.

Therefore, general wellness products typically encompass exercise equipment, audio recordings, video games, software programs, and other items, which are available for direct purchase from retail outlets, including online retailers and distributors. What practical benefits should general wellness products deliver to users? Primarily, they should fulfill two key functions: 1. They are intended to maintain or promote a state of health or engage users in health-related activities; 2. They are designed to help reduce the risk of certain chronic diseases or medical conditions through healthy lifestyle practices, while fostering public awareness and acceptance of the significant role such lifestyles may play in disease prevention and management of health conditions.。

Specific Efficacy of Category I General Health Products

It can be seen that the first category of use is primarily to maintain or improve health status and is unrelated to disease. If a general health product meets the first criterion of the aforementioned definition, the manufacturer shall not claim in any form that its product can affect disease. What items does it include?

1. Weight Management;

2. Physical comfort, including products for recreational use;

3. Relaxation or Stress Management;

4. Psychological Acuity;

5. Self-esteem management (e.g., devices with cosmetic functions);

6. Sleep Management;

7. Sexual Function.

The following outlines the expected outcomes for Class I general health products, as stipulated in the draft regulations:

1. Promote or maintain a healthy weight, encourage a healthy diet, or assist in achieving weight loss goals;

2. Promote relaxation and stress management;

3. Increase, improve, or enhance "energy";

4. Enhance cognitive acuity, such as command following, attentional focus, problem-solving, multitasking, resource management, decision-making, logical reasoning, pattern recognition, or hand-eye coordination;

5. Enhance learning ability;

6. Physical health, such as assisting with logs, tracking, or trending exercise activities; measuring aerobic fitness; improving physical condition; developing or enhancing endurance, strength, or coordination; or boosting energy levels;

7. Sleep management, such as recording sleep habits;

8. Self-Esteem Management;

9. Addressing specific bodily structures or functions, such as increasing or improving muscle size or physique, or enhancing sexual performance;

10. Enhance flexibility, or assist individuals with mobility impairments in participating in recreational activities (e.g., sports wheelchairs);

11. Enhance individual engagement in recreational activities by monitoring data such as heart rate, exercise frequency, and impact from collisions.

Promoting products with the following features does not comply with CDRH regulations:

1. Diagnosis or treatment of obesity;

2. Treatment of eating disorders, such as anorexia nervosa;

3. Helps treat anxiety disorders;

4. A computer game will diagnose or treat autism;

5. Can treat muscle atrophy or erectile dysfunction;

6. Restore structural or functional impairments caused by diseases, such as claiming that prosthetics enable amputees to walk.

Under these definitions, the FDA regulates such health products in accordance with guidance documents.Therefore, manufacturers may state that their products can help control weight, but they cannot claim that their products can treat or diagnose obesity.

Specific Efficacy of Category II General Health Products

The focus of general health products in the second category is that manufacturers may claim their products do more than just help achieve a certain healthy lifestyle, linking these outcomes to potential benefits for specific diseases. To some extent, this implies that the product itself can help alleviate or reduce the risk associated with these diseases. Therefore, it has two subcategories:

1. Used to promote, track, or encourage the adoption of a healthy lifestyle, which may help reduce the risk of certain chronic diseases or other conditions;

2. Used to promote, track, or encourage the adoption of a healthy lifestyle, which may help in long-term management of certain chronic diseases or other conditions.

The common characteristic of both subcategories is the belief that a healthy lifestyle can help improve chronic diseases such as heart disease, hypertension, and type 2 diabetes, and that these therapeutic effects must be validated in scientific publications or by professional healthcare institutions. The following are relevant examples:

1. The software product teaches breathing and relaxation techniques; this healthy lifestyle may help slow the progression of migraines;

2. The software product V tracks and records your sleep, work, and exercise patterns; this healthy lifestyle helps alleviate anxiety;

3. Product W promotes healthy lifestyle habits, such as getting adequate sleep, maintaining a balanced diet, and achieving a healthy body weight, which may help alleviate the symptoms of type 2 diabetes;

4. Product X promotes physical activity and may help reduce the risk of hypertension;

5. Software product Y tracks your calorie intake and helps you maintain a healthy eating plan to sustain a healthy weight and balanced diet, thereby improving the quality of life for patients with hypertension and type 2 diabetes;

6. Product Z tracks sleep patterns during activities and promotes healthy sleep habits, which may help reduce the risk of type 2 diabetes。

As noted in the FDA Law Blog’s coverage of the draft guidance, general health products falling under the second category appear to afford manufacturers some leeway to establish specific associations between their products and certain diseases or health conditions. For example, the FDA has indicated that manufacturers may market products that promote physical activity and claim that such products “may help reduce the risk of high blood pressure.”

How to Determine Low Risk?

The general health policies drafted by the CDRH apply only to general wellness products, which must be low-risk. Products posing high risks will not qualify for exemption. How is risk defined? The following three conditions must be met:

1、Does the product have diffusivity?

2、Is the product an implantable device?

3、If specific regulatory controls are not applied to the interventions or technologies involved in the product, they may pose hazards to users or safety, such as risks from laser or radiation exposure.

When assessing whether a product is low-risk, the FDA advises its Center for Devices and Radiological Health (CDRH) to consider whether there are similar products already on the market. If such comparable products have issues, the application will not be approved. For example, in the “21 CFR 876.5020 》 Under the provisions, penile rigidity adjustment devices classified as Class II medical devices may pose risks of tissue damage, trauma, or infection, and are therefore not considered low-risk products. The following products are also not regarded as low-risk health products:

1、Sunlamp products: Due to user safety risks, excessive ultraviolet radiation may increase the risk of skin cancer.；

2、Implants used for cosmetic purposes or to enhance sexual function may carry risks such as rupture or other adverse reactions.；

3、Laser products can improve skin conditions but also pose risks of skin and eye burns.；

4、A neurostimulation product claims to enhance memory, but safety concerns regarding electrical stimulation warrant caution.；

5、Products claiming to enhance athletic performance based on relative lactate testing are not considered low-risk when they require blood samples obtained via skin puncture, as this is an invasive procedure (obtaining blood samples through skin puncture or venipuncture carries a risk of infection transmission).。

What Should Low-Risk General Health Products Look Like? Here Are Some Examples:

1. A mobile music-playing application designed to soothe emotions, provide assistance and relaxation, and facilitate stress relief. From a promotional standpoint, the product claims only to alleviate stress and is not associated with the treatment of diseases; furthermore, the music playback technology does not pose any health risks.

2. An application that only monitors and records daily energy expenditure and cardiovascular exercise activities merely helps individuals raise their awareness of physical activity to improve or maintain good cardiovascular health. Even if the data are inaccurate, no danger will arise;

3. A mobile application for weight management that monitors and records food consumption, thereby generating dietary activity data, is also low-risk;

4. A mobile application that alerts users when they are exposed to direct sunlight with a high UV index, helping to reduce the risk of skin cancer;

5. A portable product designed to monitor the user's pulse rate during exercise and hiking. It is not intended for disease treatment, and the technology poses no risk even in the absence of monitoring;

6. Mechanically remove the stratum corneum from the face, hands, and feet to make the skin smoother and softer. This product must not be used in a manner that penetrates or pierces the skin. As long as the skin is not pierced, the product does not exhibit diffusivity.