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FDA Warning Letter Explorer
FDA warning letter · Drugs

Meta Labs Pharmaceuticals, LLC

Issued · Posted by FDA

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

The claims on your website and product labels establish that these products are drugs under section 201(g)(1)(B) of the Act [21 U.S.C. 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease.

Passage 2

Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” under section 201(p) of the Act [21 U.S.C. 321(p)].

Passage 3

Accordingly, Diabetic Advantage, Yacon Root Extract, Nattokinase Max, Viral Immune Booster, and Respiratory Response fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)].

Passage 4

You failed to establish product specifications for the identity, purity, strength, composition of the finished batch of dietary supplement, and for limits on those types of contamination that may adulterate, or that may lead to the adulteration of, the finished batch of dietary supplement to ensure the quality of the dietary supplement, as required by 21 CFR 111.70(e).

Passage 5

You failed to establish, for each component that you use in the manufacture of a dietary supplement, identity specifications for each component; component specifications that are necessary to ensure that specifications for the purity, strength, and composition of dietary supplements manufactured using the components are met; and limits on the types of contamination that may adulterated or may lead to the adulteration of the finished batch of dietary supplement to ensure the quality of the dietary supplement, as required by 21 CFR 111.70(b).

Passage 6

You failed to establish master manufacturing records (MMRs) that identify specifications for the points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the MMR, as required by 21 CFR 111.205(b)(1) and in accordance with 21 CFR 111.210.

Passage 7

Your batch production record (BPR) failed to include complete information relating to the production and control of each dietary supplement batch manufactured, as required by 21 CFR 111.255(b) and in accordance with 21 CFR 111.260.

Passage 8

You failed to establish and follow laboratory control processes that are reviewed and approved by quality control personnel for the use of criteria for selecting standard reference materials used in performing tests and examinations, as required by 21 CFR 111.315(d).

Citations in the original letter

As cited in this historical letter, not a statement of current regulatory requirements.

  • 21 CFR 111
  • 21 CFR 111.70(e)
  • 21 CFR 111.75(c)
  • 21 CFR 111.70(b)
  • 21 CFR 111.75(a)
  • 21 CFR 111.75(a)(1)(i)
  • 21 CFR 111.75(a)(1)(ii)
  • 21 CFR 111.75(a)(2)(ii)
  • 21 CFR 111.205(b)(1)
  • 21 CFR 111.210
  • 21 CFR 111.210(d)
  • 21 CFR 111.210(f)
  • 21 CFR 111.210(g)
  • 21 CFR 111.210(h)(1)
  • 21 CFR 111.210(h)(2)
  • 21 CFR 111.210(h)(3)
  • 21 CFR 111.210(h)(5)
  • 21 CFR 111.255(b)
  • 21 CFR 111.260
  • 21 CFR 111.260(c)
  • 21 CFR 111.260(f)
  • 21 CFR 111.260(l)(1)(i)
  • 21 CFR 111.260(k)(1)
  • 21 CFR 111.315(d)
  • 21 CFR 201.5