< Safety & Toxicology>

Natural products are believed by the public to be largely free of toxicity. For most natural ingredients sold as dietary supplements the toxic dose is so high as to be unlikely to be consumed by humans. However, some natural products may cause side effects within the recommended intake range. Nevertheless, evidence of safety is critically important.

FDA has the statutory authority under the Dietary Supplement Health and Education Act of 1994 (DSHEA) and other Acts passed by Congress to:

1) Refer for criminal action any company that sells a dietary supplement that is toxic or unsanitary [Section 402(a)].

2) Seize dietary supplements that pose an "unreasonable or significant risk of illness or injury" [Section 402(f)].

3) Stop a new dietary ingredient from being marketed if FDA does not receive enough safety data in advance [Section 413].

4) Stop the sale of an entire class of dietary supplements if they pose an imminent public health hazard [Section 402(f)].

AIBMR believes that companies manufacturing or distributing dietary supplements must realize the importance of substantiating the safety of its products. This can be done by being able and prepared to:

1. Substantiate the safety of the ingredient and/or product in question. This means you have the published or proprietary toxicological data needed;

2. Submit toxicological studies that your company has commissioned or conducted that demonstrate the ingredient and/or product are safe as directed; and,

3. Document that the manufacturing of the ingredients and/or product met current Good Manufacturing Practices (cGMPs), including substantiation of the product’s potency, cleanliness and stability as required by the law [Section 402(g)].

AIBMR is prepared to assist your company in substantiating the safety of your ingredients and/or products. We have experience in organizing and commissioning toxicology studies on behalf of our clients and publishing those results if desired. This includes acute, subacute, chronic, carcinogenicity, and specialized toxicity testing, including neurotoxicology, pharmacokinetics, reproductive toxicology, and immunotoxicology, by various routes of administration. All of these studies are conducted according to Good Laboratory Practice (GLP) regulations.

AIBMR can assist companies in substantiating the microbiological safety of the product according to accepted in vivo and in vitro studies and analytical protocols.

We also monitor new developments and methods in non-animal toxicology testing.

Remember the famous saying by Paracelsus, "All things are poisons, for there is nothing without poisonous qualitites. It is only the dose which makes a thing a poison."