News

Earthlight® Whole Food Vitamin D Receives Food Additive Petition Approval for the U.S. Market

July 13, 2020

MORRISTOWN, NJ 13 JULY 2020 – (PLT Health Solutions, Inc.) announced that Earthlight® Whole Food Vitamin D has received approval of its Food Additive Petition from the U.S. Food & Drug Administration, paving the way for this unique dietary ingredient to be used in food and beverages produced and sold in the United States. After extensive review of this mushroom-based ingredient, the U.S. FDA has positively assessed the safety of Earthlight Whole Food Vitamin D and published a notice of its permissible use as a nutrient supplement for food in the Code of Federal Regulations – CFR 172.382.  The approval covers Earthlight’s use in a broad range of food and beverage products, ranging from breakfast cereals and bakery products to juices and meal replacements. The approval also covers use of Earthlight in five food categories that until now were not covered in the CFR for Vitamin D fortification: fruit smoothies, soups and soup mixes, vegetable juices, extruded vegetable snacks and plant-based meat analogues.

According to Devin Stagg, Chief Operating Officer at PLT Health Solutions, FDA approval of Earthlight is timely considering rapidly growing interest in Vitamin D supplementation. “Earthlight is the right ingredient at the right time for food and beverage producers in the United States. Adequate levels of Vitamin D have always been important, but today, people are more tuned into D than ever. As a whole food, plant-based, clean label ingredient, Earthlight supports virtually every major food and beverage market trend and can really help product developers differentiate their offerings if they choose to fortify with Vitamin D,” he said.  Stagg went on to point out that Earthlight is simultaneously non-GMO, organic and a whole food – pointing to the trends that favor all these attributes with today’s consumers.

Plant-based, Whole Food Vitamin D

Earthlight is produced from mushrooms via a patented (U.S. Patent #8,545,915) process, by exposing these mushrooms to light. Much like the human body, mushrooms produce Vitamin D when exposed to UV light. Earthlight is a whole food ingredient that is minimally processed without any extract solvents. It offers consumer-friendly labeling as ‘mushroom powder’ or ‘mushroom powder Vitamin D’. This non-GMO ingredient delivers 1,000 micrograms (40,000 IU) of Vitamin D per gram of ingredient. Earthlight’s high concentration of Vitamin D means low use levels and excellent economics. Low use levels mean that it won’t affect the organoleptics of a food or beverage product. Earthlight is available in both conventional and organic grades.

Approved Use in a Broad Range of Food & Beverage Products

Earthlight is approved for use in many food & beverage products that have traditionally featured Vitamin D fortification, like breakfast cereals and meal replacements. But it is also approved for up and coming food and beverage types – particularly in the plant-based category.  Table 1 reviews the food  and beverage groups in which Earthlight may be used:

Table 1: U.S. FDA Approved Uses for Earthlight® Whole Food Vitamin D

Application Category

EXISTING

  • Breakfast cereals
  • Grain products & pastas
  • Plant milks
  • Plant yogurts
  • Soy-based beverages
  • Soy-based spreads
  • Soy-based cheeses & cheese products
  • Soy-protein based meal replacement beverages
  • Fortified fruit juices
  • Meal replacement beverages
  • Meal replacement bars (special diet)
  • Fruit juice drinks
  • Baked goods & baked snacks

NEW

  • Vegetable snacks
  • Fruit smoothies
  • Vegetable juices
  • Plant-based meats
  • Soups & soup mixes (non-meat)

According to Barbara A. Davis, PhD, RD, Head of Clinical & Regulatory Sciences for PLT, FDA approval of Earthlight is the culmination of years of work on the safety of the ingredient. “We’re pleased that U.S. FDA found our safety information acceptable and despite the hard work required, we are fully supportive of the Food Additives Petition process,” she added.

For the Federal Register Rule, visit here: https://www.federalregister.gov/documents/2020/07/13/2020-13822/food-additives-permitted-for-direct-addition-to-food-for-human-consumption-vitamin-d2

LEARN MORE ABOUT EARTHLIGHT HERE