Why is elderberry syrup not FDA approved?

Elderberry syrup has become an increasingly popular herbal remedy in recent years, valued for its purported benefits in relieving cold and flu symptoms. However, elderberry syrup has not been approved by the U.S. Food and Drug Administration (FDA). There are several reasons why elderberry syrup lacks FDA approval.

What is Elderberry Syrup?

Elderberry syrup is made from the berries of the elderberry plant (Sambucus nigra). The berries are cooked with water and sugar to make a concentrated syrup. Elderberry syrup has long been used in traditional folk medicine as a remedy for colds, flu, and other respiratory infections. It is believed to have antimicrobial and immune-boosting properties. The syrup is rich in vitamin C and antioxidants like flavonoids, which are thought to support immune function.

Elderberry Syrup Uses

Elderberry syrup is commonly taken at the first signs of a cold or flu for symptom relief. It is used to:

  • Shorten duration of colds and flu
  • Reduce symptoms like fever, headaches, sore throat, cough, and congestion
  • Boost immune function to fight viral infections

Some studies have suggested elderberry can inhibit the replication of influenza viruses and reduce inflammation associated with infections. However, the evidence is still limited when it comes to elderberry’s effects on colds and flu.

Elderberry Syrup Benefits

Some key potential benefits associated with elderberry syrup include:

  • Antioxidant effects: Elderberries contain polyphenols and anthocyanins with antioxidant and anti-inflammatory activity.
  • Immune support: Compounds in elderberry may boost cytokine production and other immune processes.
  • Antiviral properties: Test tube and animal studies indicate elderberry extracts can inhibit viral attachment and replication for influenza strains.
  • Respiratory relief: Elderberry is believed to promote respiratory health, act as an expectorant, and soothe sore throat.

Is Elderberry Syrup FDA Approved?

No, elderberry syrup has not been approved by the FDA for safety and efficacy. The FDA does not evaluate or approve natural products like elderberry syrup in the same manner as medications.

Reasons Elderberry Syrup Is Not FDA Approved

There are several key reasons why elderberry syrup lacks FDA approval:

  • Insufficient research: There have not been enough large scale human trials on elderberry for colds and flu to support approval.
  • Safety concerns: Potential side effects and risks with long-term use are not well established.
  • Standardized production: There are no regulated standards for elderberry syrup production and quality control.
  • Health claims: Elderberry companies cannot make medical treatment claims that their products cure or prevent disease.

Let’s explore these reasons and the FDA approval process in more detail.

Insufficient Research

For the FDA to approve any medication or natural health product, substantial research and clinical evidence must demonstrate it is safe and effective for its intended uses. Currently there is insufficient scientific evidence from large, randomized controlled trials to conclusively prove elderberry syrup’s benefits.

Many studies on elderberry have had small sample sizes, lacked placebo controls, tested combinations with other herbs, or have other limitations. The largest, most rigorous study to date was published in 2019 in the Journal of General Internal Medicine. This randomized, double-blind, placebo-controlled trial with 312 airline passengers found no significant difference between elderberry extract and placebo for cold duration or symptoms.

While some lab and animal research shows promising antiviral and anti-inflammatory effects from elderberry, extensive clinical research in humans is needed to validate these results and gain FDA approval.

Safety Concerns

To gain FDA approval, a substance must have undergone thorough safety testing to identify potential side effects and risks, especially with long-term use. Currently, there are limited safety data on elderberry syrup.

Some potential safety concerns with elderberry include:

  • Allergic reactions in those with allergies to plants in the Adoxaceae family
  • Unsafe levels of cyanide or lectins if improperly prepared
  • Drug interactions due to effects on the immune system and possible diuretic effects
  • Safety for pregnant women, children, those with autoimmune disease is uncertain

The FDA requires extensive toxicology studies and clinical trials to determine if side effects occur and what doses are safe. These stringent safety requirements have not yet been conducted for elderberry syrup.

Standardized Production

To approve a product, the FDA also requires that manufacturing follows rigorous quality standards. There can be great variability in elderberry syrup brands in terms of:

  • Elderberry concentrates used
  • Amount of elderberry extract per serving
  • Additional ingredients added like flavors, preservatives, vitamins
  • Production methods used
  • Quality control and sanitation practices

This variability makes it difficult to ensure consistent product quality and potency. The FDA has strict cGMP regulations (current good manufacturing practices) that companies must follow to gain approval. Most elderberry syrup brands are not produced in cGMP certified facilities.

Restricted Health Claims

Finally, elderberry syrup lacks FDA approval because the FDA prohibits companies from making unsubstantiated health claims about their products treating, curing, or preventing any disease or condition. While some elderberry brands allude to benefits for immune health, they cannot state their products will treat colds or flu without extensive clinical evidence.

FDA Approval Process for Medications

To understand why elderberry syrup lacks FDA approval, it helps to look at the rigorous approval process required for medications and drugs. New medications must undergo the following phases of clinical trials to gain approval:

  • Preclinical research: Extensive lab and animal testing to determine a drug’s pharmacology, toxicity, and pharmacokinetics.
  • Investigational New Drug application: The drug sponsor formally proposes clinical studies to the FDA outlining manufacturing information, study protocols, and safety data from animal studies.
  • Phase 1 clinical trials: The drug is tested in a small group of healthy volunteers to determine a safe dosage range and identify side effects.
  • Phase 2 clinical trials: The drug is given to patients with the disease/condition to assess efficacy and optimal dosage.
  • Phase 3 clinical trials: Large controlled studies with hundreds to thousands of patients to verify efficacy, monitor adverse reactions, and compare to commonly used treatments.
  • FDA approval: The sponsor compiles all preclinical and clinical data into a New Drug Application for FDA review. Average approval takes 2-10 years.

As a natural product, elderberry syrup is not subject to these same regulations. But this extensive process illustrates the high level of scientific evidence required for FDA approval that elderberry currently lacks.

Alternative Approaches to Evaluation

Given the challenges and costs of gaining FDA approval, some alternative approaches have been proposed to evaluate elderberry syrup and similar herbal supplements:

  • Office of Dietary Supplements: The ODS at the National Institutes of Health could conduct safety and efficacy research on elderberry, as they have done for supplements like echinacea.
  • Self-affirmed GRAS: Brands could follow FDA guidelines to affirm elderberry syrup is Generally Recognized as Safe via scientific procedures.
  • Third-party testing: Independent laboratory testing by Certified for Sport, NSF International, ConsumerLab, or other groups could verify elderberry potency and purity.
  • Monograph approval: The FDA could develop an official botanical monograph outlining appropriate elderberry uses after reviewing available evidence.

While not as rigorous as the FDA new drug approval process, these approaches could help establish a stronger safety and quality basis for elderberry syrup products.

Should You Take Elderberry Syrup?

The lack of FDA approval does not necessarily mean elderberry syrup is unsafe or ineffective if used appropriately under medical supervision. Many consumers feel comfortable using elderberry syrup as an herbal supplement for immune health.

However, those considering elderberry syrup should be aware of the limited scientific evidence and lack of FDA review. It may be prudent to avoid extended or excessive use without consulting your healthcare provider. Those on medications should check for any potential elderberry interactions.

Talk to your doctor to weigh potential benefits and risks before using elderberry syrup, especially if you have any medical conditions or take any medications. While FDA approval is lacking, some laboratory and clinical research on elderberry is ongoing. Future studies may eventually substantiate elderberry’s use for colds, flu, and respiratory infections.

The Bottom Line

In summary, elderberry syrup lacks FDA approval because:

  • There is limited clinical research demonstrating safety and efficacy.
  • It does not meet stringent standards for quality manufacturing and labeling.
  • Health claims that elderberry treats or prevents disease are prohibited.

FDA approval is a lengthy, expensive process requiring extensive toxicology, dose-ranging studies, and randomized controlled trials. Elderberry syrup has not undergone this level of rigorous review by the FDA, but alternative evaluation options exist. Those considering elderberry syrup should be aware of the lack of FDA approval and limited evidence while monitoring for any side effects or interactions with medications.

Leave a Comment