Quiero saber acerca de...

khammond on DSKJM1Z7X2PROD with RULES

Federal Register / Vol. 86, No. 145 / Monday, August 2, 2021 / Rules and Regulations Letter to HelloCig Electronic Technology Co., Ltd Ref. 9 relying in part on undeclared active pharmaceutical ingredient as well as implied claims from imagery to determine products intended use; FDA
Warning Letter to Duy Drugs, Inc. Ref.
10 relying in part on undeclared sildenafil to establish intended use;
Letter from Steven B. Barber, District Director, Cincinnati District, FDA to Marc C. Sanchez, Esq., Mood and Mind, LLC, Ref. 7 at 910 relying in part on known attributes and common uses of product to establish use; Letter from Daniel Solis, Director, Import Operations Branch, Los Angeles District to Carol A. Pratt, K&L Gates LLP Ref.
11 relying in part on information available on the internet reflecting general understanding by consumers of mind-altering properties and purported medical uses of product, as well as pattern of changes to the importers website and blog to conceal the true intended use of the product by deleting references to the amount of a psychoactive component in the product; FDA Warning Letter to Lifetech Resources Labs Inc. Ref. 12
relying in part on presence of the prostaglandin analog, isopropyl cloprostenate, along with appearance claims to establish intended use; FDA
Warning Letter to INZ Distributors Ref.
13 relying in part on presence of analogue of an erectile dysfunction drug to determine products intended use.
One of the purposes of this rulemaking is to put to rest any dispute about FDAs interpretation of its statute and regulations, and its policyas embodied in this rule as well as in the precedent cited aboveregarding evidence that may be relevant to establishing intended use.
Comment 3 With respect to the many situations where manufacturers and distributors attempt to evade FDA
regulatory oversight by omitting promotional medical product claims, examples of which are provided above, one comment suggested that the Government could use other regulatory tools rather than apply FDAs authorities for premarket review of medical products. Specifically, the comment suggested that FDA employ a combination of post-market risk mitigation techniques which would require FDA to engage in the collection, review, and potential description in labeling of the risks associated with the unlabeled use before taking enforcement action against the product to protect the public health.
The same comment suggested that, alternatively, FDA could consider
VerDate Sep<11>2014

16:00 Jul 30, 2021

Jkt 253001

evidence other than promotional claims, but only to establish that in fact a promotional claim had been made.
Response FDA declines this suggestion. The fundamental purpose of the FD&C Act is to help protect the lives and health of people which, in the circumstances of modern industrialism, are largely beyond self-protection United States v. Dotterweich, 320 U.S.
277, 280 1943. Remedial legislation such as the Food, Drug, and Cosmetic Act is to be given a liberal construction consistent with the Acts overriding purpose to protect the public health United States v. An Article of Drug . . .
Bacto Unidisk, 394 U.S. 784, 798
1969. Although FDA generally considers risk as part of its determination whether to take enforcement action, part of the impetus for Congress development of the premarket review requirements was the determination that exclusive reliance on postmarket remedies, such as enforcement actions for false or misleading labeling, is inadequate because it does not prevent consumers from experiencing harm from unsafe and/or ineffective treatments.
FDAs position regarding evidence relevant to establishing intended use helps protect the public health. To describe more fully one of the examples cited above: In United States v. Johnson, 471 F.3d 764 7th Cir. 2006, the defendant imported dextromethorphan hydrobromide DXM, the active ingredient in some cough suppressants, and distributed it for recreational use.
During the 4 months his company was in operation, five customers died.
Because DXM is not a controlled substance, no charges were brought under the Controlled Substances Act, but the court found that FDA had jurisdiction under the FD&C Act id. at 765. Defendant pleaded guilty to three counts of introducing a misbranded drug into interstate commerce and received a 77-month sentence id.. In upholding that sentence, the Seventh Circuit noted that the defendant knewnot merely should have knownthat there was a substantial risk that more of his customers would die, and yet he continued to sell DXM for recreational use and failed to warn existing customers, including the two teenagers who died after he learned of the first two deaths id..
Because FDAs position on intended use helps ensure that it can help curb the distribution of dangerous and fraudulent products, FDA declines to construe intended use more narrowly than the statute provides.
Comment 4 One comment objected to FDAs statement in the proposed rule
PO 00000

Frm 00009

Fmt 4700

Sfmt 4700

41389

that relying exclusively on firms claims to determine intended use would adversely affect public health by opening the door to the marketing of products that are unapproved for any medical use. The comment argued that there is no public health need for FDA
to rely on evidence other than express claims to determine intended use because the FD&C Act and other statutes provide other authorities that allow FDA to take action against products that contain an active ingredient from an FDA-approved drug, controlled substance, or other pharmacological ingredient. Specifically, the comment recommended that FDA use its dietary supplement and food additive authorities to keep products containing pharmacological ingredients out of dietary supplements and conventional foods, rather than using an intended use analysis to classify and regulate the products as drugs. The specific authorities mentioned in the comment were the definitions of food and dietary supplement and the corresponding adulteration provisions of the FD&C Act; the premarket notification requirement for certain dietary ingredients not marketed in the United States before October 15, 1994;
and the premarket approval requirement for food additives. Similarly, another comment argued that rather than continuing to take the approach to intended use outlined in the NPRM, the Government could apply other provisions of Federal law; and that where there are gaps in existing legal provisions, FDA could seek specific product-based legislative changes.
Response We decline the comments suggestions. Although it is true that the authorities mentioned in the comment enable FDA to keep some products containing pharmacological ingredients out of the food supply and dietary supplement marketplace, the comment overstates the reach of FDAs other authorities and overlooks the fact that simply being outside the dietary supplement or food definition does not make a product unlawful and subject to enforcement action. To establish jurisdiction over a product as a drug and remove it from the marketplace, or require the manufacturer to obtain FDA
approval for the product before marketing it, FDA must be able to establish that the product is a drug based on evidence of its intended use Thus, the regulatory tools the comment recommends are not a substitute for FDAs medical product authorities that include an intended use determination.
As the previous comment response explained, suggestions that FDA use other regulatory tools in place of
E:FRFM02AUR1.SGM

02AUR1