Pharmaceutical

FDA warns aloe vera farm over numerous violations

aloe vera Pixabay 280x210 FDA warns aloe vera farm over numerous violations The Food and Drug Administration (FDA) slammed a Texas aloe vera farm with a warning letter over the marketing and labeling of its juice and dietary supplements that the agency says are in violation of the federal Food, Drug and Cosmetic Act.

One issue involved the Aloe Farms’ classification of aloe as a vegetable. “Although we do not dispute that aloe vera is a member of the vegetable kingdom in the broad sense of classifying an article as ‘animal,’ ‘vegetable,’ or ‘mineral,’ FDA considers the term ‘vegetable’ in the context of the juice definition to refer more narrowly to edible plant parts that consumers are accustomed to eating as vegetables in their diet,” the agency wrote in the warning letter.

The juice’s labels also use the word “natural,” however the FDA says that word is misleading since the product contains a synthetic ingredient, potassium sorbate. The nutritional values are also misleading, the agency said. For example, the company’s website claims the juice has no carbohydrates but the product’s label says there are four grams of carbohydrates per serving.

Regarding the aloe supplements sold by Aloe Farms, the FDA said its supplements and Whole-Leaf Aloe Vera Capsules are not properly labeled and identified as dietary supplements and that they lack finished product specifications.

The FDA also took issue with Aloe Farms’ topical products saying the company’s various websites make claims that its aloe vera gel “cures everything” and speeds up healing of burns, wounds, bedsores and other injuries. Such claims cannot be made by products that have not gone through rigorous studies and review such as those for pharmaceuticals.

The warning letter also referenced a December inspection during which agency officials found sanitary problems and other “significant violations.”

Aloe Farms was given 15 working days o respond in writing the specific steps that it has taken to correct the numerous violations outlined in the warning letter along with an explanation of each step being taken to prevent the violations fro happening again.

Sources:
Law360
FDA