Eden’s Answers Inc. and Sprigs Life Inc. FDA Warning (2017)

Detailed Analysis

False Claims and Regulatory Violations

The FDA identified regulatory violations in Eden’s Answers Inc. and Sprigs Life Inc.'s operations or product claims.

Potential Health Risks

Consumers should be aware of potential risks associated with products from Eden’s Answers Inc. and Sprigs Life Inc..

Regulatory Context

Your Testo Strong XY product labeling information that appears on your website lists the ingredient “Siberian Ginseng.”  The term "ginseng" may only be considered to be a common or usual name (or part thereof) for any herb or herbal ingredient derived from a plant classified within the genus Panax.  Specifically, your product contains an ingredient identified as Siberian Ginseng which is Eleutherococcus senticosus. That ingredient may not be declared under a name that includes the term "ginseng" because it is not from the genus Panax. Furthermore, the Testo Strong XY labeling on your website fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1).

Your Respiratory Aid, Raw Elderberry and Honey, and Pedia Para-Free product labels must present the name and place of business on the principal display panel or the information panel in accordance with 21 CFR 101.2(b).  Further, we note that your Respiratory Aid and Raw Elderberry and Honey products list “Evergreen Distributing,” the former name of Sprigs Life, as the business name.

Your Raw Elderberry and Honey product includes raw clover honey as an ingredient.  If dietary ingredients such as sugar, total carbohydrate, or calories are present in significant amounts per serving, they must be declared in the Supplement Facts (see 21 CFR 101.36(b)(2)).