Wellness Products & Supplements
There is a growing consumer demand for wellness products. For health innovators, determining whether to proceed to market by defining a technology as a “wellness product” or a “dietary supplement” requires careful consideration.
Wellness Products
Medical devices are highly regulated in global markets. However, the legal definition of “medical device” is different in many of these jurisdictions, as well as their policies on “wellness” products. The legal and regulatory line between whether a technology is a wellness product and a medical device can be razor thin. A meticulous assessment should be conducted to determine if the product will be regulated as a medical device in the market of interest. Covita Health Partners can help you navigate these complexities and help keep you on the right side of compliance.
In the US, FDA generally considers products to be “wellness”, and therefore not regulate them, if they are low risk and are only intended to maintain or encourage a healthy lifestyle.
Some examples of applications wellness products can be intended to help consumers with are:
Weight Management
Mental Acuity
Physical Fitness
Self-Esteem
Relaxation & Stress Management
Sleep Tracking
Wellness products do not typically make references to diseases or conditions.
While it is possible to promote a wellness product for a particular disease or condition, it must only be done so where it is well understood that a healthy lifestyle could help reduce the risk of or help live with a particular chronic disease or condition. Examples of chronic diseases for which a healthy lifestyle is associated with risk reduction, or help in living well with that disease, include heart disease, high blood pressure, and type 2 diabetes.
Low Risk
It’s important to recognize that claims are not the only factor to consider when preparing to launch a wellness product in the US. The technology must also be “low-risk”. And while you may consider a product to be low-risk, it doesn’t mean that it is from a regulatory perspective. FDA specifically requires a product to meet three criteria in order for it to be “low-risk”.
1 / Must Not Be Invasive
A product that uses venipuncture to obtain blood sample for lactic acid testing and subsequent analysis to provide suggestions to enhance athletic performance is invasive and not a wellness product.
2 / Must Not Be Implanted
A product that is implanted and intended for improved self-image or self-esteem is implanted and not a wellness product.
3 / Must Not Involve an Intervention or Technology That May Pose a Risk to the Safety of Users or Other Persons if Specific Regulatory Controls Are Not Applied, Such As Risks From Lasers or Radiation Exposure
A neurostimulation product intended to improve memory introduces risks from electrical stimulation and is not a wellness product.
There are many nuances when determining a technology is a “wellness product”. CHP can help you understand the grey area and ensure your wellness product launches to the market in compliance, and is able to stay there compliantly.
Dietary Supplements
As consumers gravitate towards more “natural” and homeopathic remedies, the market is being flooded with more dietary supplements. While it is true they are regulated less than drugs, they are regulated nonetheless. FDA has the authority to take action against any adulterated or misbranded dietary supplement product after it reaches the market. The Federal Trade Commission (FTC) also has authority to take action against dietary supplement firms which employ claims in their marketing material which are not truthful, misleading, and not supported by science. It remains critical to ensure that you understand the dietary supplement regulations to protect your business and your customers from risk.
Types of Dietary Supplement Claims
FDA has categorized types of claims listed below which could be associated with dietary supplements, and each of these claims have different requirements:
Health Claims
Health claims could be "authorized" or "qualified" by FDA.
General Well-Being Claims
A statement that describes general well-being from consumption of a nutrient or dietary ingredient.
Nutrient Content Claims
A statements on the label package that indicate directly or by implication the level of a nutrient.
Classical Nutrient Deficiency Disease Claims
A statement that claims a benefit related to a classical nutrient deficiency disease and discloses the prevalence of such disease in the United States.
Structure/Function Claims
A statement that describes the role of a nutrient or dietary ingredient intended to affect or maintain a structure or function in humans.
Dietary Guidance Statements
Written or graphic material, based on recommendations from a consensus report, in labeling that represent or suggest that a food or a food group may contribute to or help maintain a nutritious dietary pattern.
Dietary supplements may make other labeling claims that are not defined by statute or regulation (e.g., claims about taste or ingredient quality), as long as those claims are not false or misleading.
CHP can you help understand the specific types of claims you can make about your dietary supplement, as well as help you with any FDA prior authorization which may be required for a claim, or any required disclaimers. Often times claims are the gateway to a dietary supplement company being on the receiving end of regulatory enforcement. We can help you position yourself for the greatest market success while staying on the right side of compliance.
Some people may also be surprised to learn there are US regulations for good manufacturing practices for dietary supplements. Whether you manufacture in-house or use a third-party, CHP is here to partner with you to ensure GMPs are met, the equipment and processes are validated properly and an appropriate quality system is established to ensure the integrity and quality of your product.