By Michael Shabaka, Ph.D., Manex Consulting
The United States defined supplements in its 1994 Dietary Supplement Health and Education Act (DSHEA) as a product taken by mouth that contains a dietary ingredient intended to supplement the diet. While food, as defined in the Food Drugs & Cosmetics Act (FD&C), are articles used for general food or drink for human or animal consumption. The DSHEA Act, in essence, created a method to regulate supplements and anyone that produces supplements falls under the regulation of the FDA. Many food manufacturers, especially smaller firms or companies that are just starting often struggle with what parts of FSMA they must comply with, in addition to what labeling is needed on their products.
In California, there are the added requirements of local and state regulations such as Prop 65, the California Department of Public Health (CDPH), or your local county laws that you must follow. Generally, if you are selling food or supplements across state lines, you must follow all federal regulations. Therefore, your product must be FSMA compliant in all areas, in addition to being compliant with any local jurisdiction requirements.
However, if you are only selling within the state of California, you can sometimes just comply with CDPH and your local laws and of course, safe handling guidelines as noted in FSMA where applicable, such as the Foreign Supplier Verification Programs (FSVP), especially if it contains foreign ingredients. In addition, you must have the basics covered, such as effective HACCP and cGMP/GMP plans to ensure you’re manufacturing in a sanitary and low hazard environment.
Now, let’s look at the labeling requirement differences between the two. Dietary supplement labels are not required to be pre-approved by FDA, however, you must provide the FDA notification with the text of the structure/function claim no later than 30 days after marketing the product. There is a lot of grey area around this when it comes to interstate sales and Manex recommends that you follow this process and notify the FDA. The risk you run is the possibility of someone getting sick from your supplement, which then puts your processes under a compliance microscope that can shut down your production. With general food, there is no FDA notification required, however, the FDA can take action against you if your label is non-compliant.
When it comes to food labeling, it is required that dietary supplement labels include a Supplement Facts Panel, rather than a Nutrition Facts Panel. This is generally required for all FDA-regulated foods. General foods and dietary supplements must comply with all requirements as detailed in 21 CFR 101 regulations for food labeling. The FDA can determine general foods and dietary supplements as misbranded when they fail to meet applicable label claims or labeling requirements provided in the 21 CFR 101 regulation. This is the key reason why Manex recommends that even if you do not have interstate sales, you should be fully compliant with all label requirements – especially if your product has the potential to be resold.
Prior to FSMA, companies got around this requirement by having their supplement products be sold on a subscription basis only. That loophole is now closed, and it may be a good time to review your food labels and ensure you are compliant.
About the Author
Michael Shabaka, Ph.D., is the Director of Sales and Innovation Excellence for Manex. He has over 20 years of business development, sales and marketing experience, spanning several industries including biotech, high tech, publishing, environmental lab services, and the non-profit sector. Dr. Shabaka holds a Ph.D. in Organizational Behavior with a concentration in Transformative Learning and Change from the California Institute of Integral Studies, San Francisco. He also holds a Master of Business Administration degree in Marketing and Finance and a Bachelor of Arts degree in International Affairs from Holy Names College, Oakland. He can be reached at firstname.lastname@example.org.