Important Safety Information

Critical information about LACTIVAE™ (raw milk, oral solution)

Modern Safety Evidence (2005-2020)

Recent peer-reviewed research challenges common perceptions about raw milk safety. A 2024 study published in the Journal of Epidemiology and Global Health analyzed 16 years of CDC surveillance data (2005–2020), and an earlier analysis examined outbreak trends against legalization and consumption growth (2005–2016):18,19

0–2 deaths

Total deaths from raw milk in 16 years (vs. 5 deaths from pasteurized dairy)18

74% decrease

In outbreak rates from 2005 to 2016, after adjusting for growth in population and consumption19

Zero illnesses

Reported in California (2016–2020) despite retail grocery store sales18

0 typical, 10 max

Hospitalizations from raw milk per year nationally: typically zero, never more than 1018

Sources: Stephenson MM, et al. J Epidemiol Glob Health. 2024;14(3):787-816.18 Whitehead J, Lake B. PLoS Curr. 2018;10:ecurrents.outbreaks.bae5a0fd685616839c9cf857792730d1.19

Comparative Risk Context

Deaths by food, CDC outbreak surveillance 2005–2020:18

  • Cantaloupe: 38 deaths (19x more than raw milk)18
  • Peanut butter: 10 deaths (5x more than raw milk)18
  • Leafy greens: 6 deaths (3x more than raw milk)18
  • Pasteurized dairy: 5 deaths (2.5x more than raw milk)18
  • Raw milk: 0–2 deaths18

Regulatory Position

LACTIVAE™ (raw milk, oral solution) is not FDA approved. The U.S. Food and Drug Administration states that raw milk can harbor dangerous microorganisms that can pose serious health risks.24

The 2024 study concluded: “The available evidence conflicts with assumptions of zero risk for pasteurized milk and increasing trends in the burden of illness for raw milk.”18

WHO SHOULD NOT CONSUME LACTIVAE™

Source: U.S. Food and Drug Administration. FDA.gov. 2024.24

Children Under 5

Young children have developing immune systems and are at higher risk for severe complications from foodborne illness.

Adults Over 65

Older adults may have weakened immune systems and are more susceptible to serious infections.

Pregnant Women

Listeria infection during pregnancy can cause miscarriage, stillbirth, premature delivery, or life-threatening infection of the newborn.

Immunocompromised Individuals

People with HIV/AIDS, cancer patients undergoing treatment, transplant recipients, or those on immunosuppressive medications face significantly elevated risks.

Potential Health Risks

Harmful Bacteria

Raw milk can contain dangerous bacteria including:

  • Campylobacter - Leading cause of bacterial diarrhea
  • Salmonella - Can cause severe gastrointestinal illness
  • E. coli O157:H7 - Can cause kidney failure (HUS)
  • Listeria monocytogenes - Particularly dangerous for pregnant women
  • Brucella - Can cause chronic recurring fever

Common Symptoms

  • Diarrhea (sometimes bloody)
  • Stomach cramping and pain
  • Nausea and vomiting
  • Fever and chills
  • Headache and body aches

Serious Complications

  • Hemolytic Uremic Syndrome (HUS) - Kidney failure requiring dialysis
  • Guillain-Barré Syndrome (GBS) - Paralysis that can be permanent
  • Reactive Arthritis - Chronic joint inflammation
  • Miscarriage or Stillbirth - From Listeria infection during pregnancy

Risk Mitigation Strategies

If you choose to consume raw milk despite the risks, follow these guidelines:

  • Purchase only from licensed, regularly inspected producers who test their milk frequently
  • Maintain refrigeration at 38-40°F (3-4°C) at all times - never leave at room temperature
  • Consume within 7-10 days of production
  • Discard immediately if you notice off-odors, unusual taste, or visible contamination
  • Visit the farm to understand their sanitation and animal health practices
  • Keep raw milk separate from other foods to prevent cross-contamination
  • Use dedicated containers and utensils for raw milk

Regulatory Status

Federal: The sale of raw milk for human consumption across state lines is prohibited by the FDA under 21 CFR 1240.61.

State Laws: Regulations vary significantly by state. Some states allow retail sale, others permit only farm sales, and some prohibit raw milk sales entirely. Check your local regulations.

International: Most developed countries recommend against raw milk consumption. The CDC, FDA, and American Academy of Pediatrics all advise against drinking raw milk.

For More Information

LACTIVAE™ (raw milk, oral solution) is not FDA approved. Raw milk may contain harmful bacteria. Not recommended for: Children under 5, adults over 65, pregnant women, or immunocompromised individuals. Click to read more