The FDA has warned Mannatech of witnessed manufacturing and labeling violations.

In a November 14th letter addressed to CEO and President Alfredo Bala, the FDA reveals it inspected Mannatech’s manufacturing facility for roughly a fortnight beginning December 28th, 2016.

The regulator also reviewed the labeling of Mannatech products in May, 2017.

Mannatech products targeted for violations by the FDA include:

  • BounceBack – classified as an “unapproved new drug”
  • MannaBears – incorrectly labelled as containing “no artificial color”, contains fruit juice color and vegetable juice color
  • MannaBears – ingredients carrots, cauliflower, kale, papayas, pineapple juice powder, tomatoes and broccoli cited as providing vitamins A, B6, C, E and K, thiamin, iron, riboflavin, niacin, folate, calcium, phosphorus, biotin, manganese, beta-carotene, potassium and dietary fiber, MannaBears nutrition facts label lists none of these ingredients
  • MannaBears – serving size errors on labeling makes provided nutritional information incorrect
  • MannaBears – cited as a dietary supplement in marketing but not identified as such on product labeling
  • Catalyst – incorrectly labelled as providing “100% or more of the daily value of vitamins, A, D and E”
  • TruSHAPE – product labeling makes nutrient content claims for antioxidants, yet doesn’t contain any ingredients with established RDI (required for antioxidant claims)
  • TruSHAPE – product labeling claims TruSHAPE “contains significant amounts of vitamins B, C and E”, but fails to meet 20% or more RDI requirement for claimed vitamins
  • ImmunoSTART – colostrum ingredient cited as providing “nutrients such as vitamins, minerals”, product labeling fails to identify specific nutrients, vitamins and minerals
  • ImmunoSTART – colostrum ingredient cited as providing “3 to 4 times more protein than regular cow’s milk”, product labeling fails to quantify amount of protein (min 10% RDI required)
  • TruPLENISH – incorrectly marketed as a dietary supplement and meal replacement

The FDA also went on raise additional concerns about MannaBears, including;

  • the grouping of fruit and vegetable powders, which suggests they are not listed by weight
  • the use of an FDA disclaimer on MannaBears labeling, which is not required for conventional foods
  • the labeling of MannaBears as gluten-free
  • referring to MannaBears as “a great source of glyconutrients”, which the FDA claims is “misleading” and not “a meaningful term that consumers would understand”

With respect to Mannatech’s manufacturing violations, the FDA claim their inspection

revealed (Mannatech) failed to comply with Current Good Manufacturing Practice regulations for dietary supplements.

These violations cause your dietary supplement products to be adulterated.

Mannatech responded to the FDA’s concerns on January 31st, 2017. In their November letter however the regulator claims it has been ‘unable to determine the adequacy of (Mannatech’s) corrective actions‘.

Mannatech was given fifteen days from the date of the FDA’s November 14th letter of warning.

The FDA has stated it will conduct another inspection of Mannatech’s manufacturing facilities.

Whether anything further comes of the FDA’s warnings remains to be seen.