FSMA: Letter of Guarantee, Affidavit

As governmental oversight and enforcement in the US becomes stricter and potentially more costly for US importers, wholesalers and retailers, foreign manufacturers will be asked to vouch for the safety and label compliance of their exported products.

That’s why more and more industrial and retail customers in the US request a legally binding Letter of Guarantee or and Affidavit from their foreign suppliers that they do not ship adulterated or misbranded food – as defined by the Food & Drug Administration.

Similarly, the increasing wave of lawsuits in California due to non-compliance with Prop 65, or the potential wave of lawsuits in Vermont, due to non-compliance with the Non-GMO law C.P. 121

Here’s the text for the Letter of Guarantee recommended by the authorities:

Letter of Guarantee: Safety

(1) Limited form for use on invoice or bill of sale (i.e. limited to a specific shipment of an article, in which case it may be a part of or attached to the invoice or bill of sale covering such shipment)

(Name of person giving the guaranty or undertaking) hereby guarantees that no article listed herein is adulterated or misbranded within the meaning of the Federal Food, Drug, and Cosmetic Act, or is an article which may not, under the provisions of section 404, 505, or 512 of the act, be introduced into interstate commerce.

(Signature and post-office address of person giving the guaranty or undertaking.)

(2) General and continuing form (considered to have been given at the date such article was shipped or delivered by the person who gives the guaranty)

The article comprising each shipment or other delivery hereafter made by (name of person giving the guaranty or undertaking) to, or in the order of (name and post-office address of person to whom the guaranty or undertaking is given) is hereby guaranteed, as of the date of such shipment or delivery, to be, on such date, not adulterated or misbranded within the meaning of the Federal Food, Drug, and Cosmetic Act, and not an article which may not, under the provisions of section 404, 505, or 512 of the act, be introduced into interstate commerce.

(Signature and post-office address of person giving the guaranty of undertaking.)

Letter of Guarantee: color additives for foreign manufacturers:

(Name of manufacturer and agent) hereby severally guarantee that all color additives listed herein were manufactured by (name of manufacturer), and (where color additive regulations require certification) are from batches certified in accordance with the applicable regulations promulgated under the Federal Food, Drug, and Cosmetic Act.

(Signature and post-office address of manufacturer.)

(Signature and post-office address of agent.)

Letter of Guarantee; GMO

As the Vermont law Consumer Protection Rule # 121 comes into effect July 1, 2016, US importers and their foreign suppliers may have to send to their customers the following sample Letter of Guarantee or Affidavit

I, ________________________, as the authorized agent of the manufacturer/producer listed above, hereby depose and state as follows:

The above named product(s) contains NO ingredients, additives or processing aides derived from commodities or seeds that have commercially grown genetically engineered varieties in the supply chain (i.e. contains no soybean, corn, cotton, canola, beet sugar, squash or papaya) or have not been knowingly or intentionally produced with genetic engineering and has been segregated from and has not been knowingly or intentionally commingled with food that may have been produced with genetic engineering.

I declare or affirm, under penalty of perjury, that the above statement is true and correct to the best of my knowledge.

Alternative:

The above named product(s) contain ingredients, additives or processing aides derived from commodities that have commercially grown genetically engineered varieties in the supply chain, BUT do not contain material derived from genetically modified plants because they have been sourced from traditional crops under an identity preserved program that is documented by the supplier.

It may help foreign manufacturers to obtain a Non-GMO certification, if this will help to sell and market their products in the US. The most widely recognized NON-GMO seal on food products comes from the Non-GMO Project.

More facts to know:

FSMA: The Meaning of Misbranded Foods
California Proposition 65
Vermont Non-GMO law
FSMA: The Meaning of Adulterated Foods