Making and Selling Elderberry SyrupAdair Hoover

The production and sale of elderberry syrup is oddly complicated. It is unique because it can be sold retail or wholesale, may be classified as a food or as a dietary supplement, and can be prepared as a shelf-stable food or refrigerated food.

The following information describes elderberry syrup, how and why it is classified, who regulates it, and food safety testing requirements.

Elderberry OverviewElderberries (Sambucus nigra) are a small fruit that grows on a bush or small tree. They are native to the northwest region of the United States and Europe. Like many fruits and berries, elderberries have a reputation for being a good source of nutrition. Historically elderberries have been used worldwide for medicinal purposes.

Elderberries can be toxic when eaten raw but are safe to eat when cooked. That is why boiling them down to make a “syrup” or “gummy” is a standard preparation method. Elderberries have a “high” pH, around pH 4.9, and are therefore classified as a “low acid food.” Preparation and packaging requirements are based on the food safety implications of the high pH.

The common method for preparing elderberry syrup is to add fresh or dehydrated elderberries to water and boil for 1-2 hours. The solids are strained out resulting in an elderberry-infused water, basically an “elderberry tea.” The infused water is then added to some type of syrup (honey is common) to make elderberry syrup.

Producers should consider the following factors when deciding how to make and sell their products.

Elderberry Syrup or Gummies sold as a supplement

That means the syrup or gummies are not a food; they are a dietary supplement. The use of any expressed or implied health claims makes the product a dietary supplement, not a food. Supplements are regulated by the FDA.

FDA guidance on Dietary Supplements for industry are included in the following links. FDA suggests that when creating the supplement label, producers visit https://www.fda.gov/ and search for elderberry syrup. Warning letters have been issued for label/labeling violations so preliminary research can help producers understand what is being looked at in advertisements as well as on product labels. Since FDA

Investigators cannot consult with firms, producers are encouraged to contact the Center for Food Safety and Applied Nutrition for assistance.

https://www.fda.gov/food/dietary-supplements/information-industry-dietary-supplements

https://www.fda.gov/food/dietary-supplements

Contact information for CFSAN

https://www.fda.gov/about-fda/center-food-safety-and-applied-nutrition-cfsan/contact-cfsan

21 CFR 111

https://www.ecfr.gov/cgi-bin/text-idx?SID=0e74632e09f343bc3f2bfd11bb0a47a1&mc=true&node=pt21.2.111&rgn=div5

Pros:

If your goal is to make health claims, you have more options when selling as a supplement. The retail store placement will help to convey health claims or benefits. It will likely be located in

the pharmacy section with other supplements.

Cons:

Navigating FDA regulations can be daunting.

Support:

The Clemson Extension Food2Market Program offers testing for pH and/or water activity, with results written into a process control letter (if needed by FDA). The Clemson Extension Food2Market program can also generate a supplement facts panel; however, the producer will be responsible for making sure that it meets FDA requirements.

Elderberry Syrup that is sold as a wholesale food.

That means that the producer is marketing the syrup as a food and plans to sell it to other businesses to sell. The South Carolina Department of Agriculture regulates elderberry syrup sold as a wholesale food product. An overview of the process to become registered with SCDA is as follows:

1. Produce food in an approved kitchen (a home kitchen is not approved).2. Have product(s) tested by a process authority.

a. Both shelf-stable and refrigerated elderberry syrups must be tested for pH to ensure the product’s finished pH is 4.1 or lower. This is because elderberries are a low acid food and raw honey is often added after the heat-treatment. If the finished pH is not 4.1 or lower then reformulation will be required. Elderberry syrups must be acidified. Examples of acidifiers include lemon juice, orange juice, lime juice, and citric acid. Most shelf-stable elderberry syrups will be classified as an “acidified food” which will require that the producer attend a Better Process Control School for acidified foods and file their facility and process with the FDA.

b. Contact Clemson Extension’s Food2Market program for process authority testing. www.clemson.edu/extension/food2market

c. If the product’s recipe is changed after product testing and, then the product’s new recipe must be re-tested by the processing authority.

3. Apply for your Registration Verification Certificate (RVC). This certificate must be obtained before products can be sold. Submitting this application initiates the first inspection of your facility and process.

4. Have product labels reviewed by the South Carolina Department of Agriculture.5. Have regular inspections by SCDA.

Pros:

In South Carolina there is a clear path to registration with regulatory and educational support available throughout the process.

Cons:

No health claims are allowed, including: word of mouth, social media, website, and packaging. Do not use the word “tonic” on the label or provide dosage instructions. These denote the product

as a supplement. The placement of shelf-stable elderberry syrup in retail establishments (grocery stores, markets,

etc.) will be with foods. For example, next to pancake syrups.

Support:

SCDA will require that you have the product tested for pH if you want to sell a refrigerated or shelf-stable product. The Clemson Extension Food2Market Program can test and issue the results in a process control letter; however, there will likely be a thermal process recommendation for food safety. Many producers don’t like to incorporate a thermal process because it may diminish the “benefits” of raw honey.

Clemson Extension Food2Market can also generate nutrition facts panels.

Elderberry Syrup sold direct to the end consumer.

This sales model would be regulated by the South Carolina Department of Health and Environmental Control (SC DHEC). Producers would need to work with SC DHEC directly. SC DHEC may be able to classify your product as non-potentially hazardous based on formulation. However, as a first step, SCDHEC will require an initial (one-time) testing for pH by a Process Authority.

Process options for retail:

1. Permitted retail food establishment: Sell product as refrigerated food, with pH of each batch confirmed to be 4.1 or lower. This is because elderberries are a low acid food and raw honey is often added after the heat-treatment. Recipe, process instructions, and testing report submitted to DHEC for review. Facility must test each batch to confirm pH <4.1.

2. Permitted retail food establishment: Sell product as shelf stable food, with pH of each batch confirmed to be 4.6 or lower. Product hot filled according to Process Authority guidance. Recipe, process instructions, copies of process letter and BPCS certificate submitted to DHEC for review. Facility must test each batch to confirm pH 4.6 or lower.

3. If the product’s recipe is changed after product testing and approval by SC DHEC, then the product’s new recipe must be re-tested and approved.

4. No health claims are allowed, including: word of mouth, social media, website, and packaging. You will only be able to produce as a food product and only sell directly to the end consumer. Also, if the product is to be sold as shelf stable, a thermal bottling process for acidified food will be required and Better Process Control certification will be required for the operator.

Support: You would be able to communicate with SC DHEC regulators for guidance at foodvariances@dhec.sc.gov.

Elderberry NutritionA note about the nutrition and supplement facts. When elderberries are infused into water and then strained out, it is impossible to know the exact quantity of nutrients that is retained. For more accurate measures a physical analysis should be performed. The Clemson Food2Market lab does not perform physical testing.

The following labs may conduct physical testing.

The University of Missouri-Columbia

Agriculture Experiment Station

https://aescl.missouri.edu/

OR

Merieux Labs

https://www.merieuxnutrisciences.com/us/

References Cited1. Author Last Name (no punctuation) First Name Initial(s), Author Last Name (no punctuation) First

Name Initial(s). Article title (use sentence case). Journal Name (use title case). Year Month-1st-three-letters;Volume(Issue):page numbers.

2. Doe J, Johnson A. This is the title of the publication. Journal Name. 2019 Mar;10(1):58–72.

Figure 1. A traditional elderberry syrup preparation starts with infusing water with elderberries, herbs, and spice. Image credit: Adair Hoover, Food Systems and Safety, Clemson Extension.

Figure 2. Traditional elderberry syrups are prepared by infusing water with elderberries, herbs, and spice. Image credit: Adair Hoover, Food Systems and Safety, Clemson Extension.

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